The Brief Pro+le summarizes the non-con+dential data on substances as it is held in the databases of the European Chemicals Agency

(ECHA), including data provided by third

parties. The Brief Pro+le is automatically generated; note that it does not currently distinguish between harmonised classi+cation and minimum classi+cation; information
requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the
responsibility to consult oIcial sources, e.g. the electronic edition of the OIcial Journal of the European Union.
This Brief Pro+le is covered by the ECHA Legal Notice.

Ceramide (Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-

(hydroxymethyl)heptadecyl])
Brief Pro+le - Last updated: 15/08/2018

Substance Description

Substance identity

EC / List name: SMILES:

IUPAC name: InChI:

Other names
Type of substance: Mono constituent substance

Origin: Organic

Registered compositions: 3
EC / List no.: 812-962-6
Of which contain: 0 impurities relevant for classi+cation
CAS no.: 34354-88-6
0 additives relevant for classi+cation
Index number:
Substance Listed:
Molecular formula:

Hazard classi5cation & labelling

Breakdown of all 3 C&L noti5cations submitted to ECHA

According to the noti+cations provided by companies to ECHA
in REACH registrations no hazards have been classi+ed.
Not Classi+ed

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

H a r m o n i s e d C l a s s i +c a t i o n
R E A C H r e g i s t ra t i o n d o s s i e r s n o t i +c a t i o n s
C L P n o t i +c a t i o n s

Properties of concern
Regulatory activities

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) Classi5cation Labelling & Packaging (CLP)

Registration Harmonised C&L:

Pre-registration:
NotiGcation: Classi+cation & Labelling has been noti+ed by industry
to ECHA for this substance.
Registration: This substance has 2 active registrations under REACH,
1 Joint Submission(s) and 0 Individual Submission(s). Biocidal Products Regulation (BPR)

Evaluation Active Substance:

Dossier Evaluation:
Biocidal Products:
Substance Evaluation:
Prior Informed Consent (PIC)
Authorisation
Annex I:
Candidate List:

Annex V:
Annex XIV (Authorisation
List): European Union Observatory for Nanomaterials (EUON)
Restriction
EUON:
Annex XVII (Restriction
List):
About this substance

General
This substance is manufactured and/or imported in the European Economic Area in 1 - 10 tonnes per year.

This substance is used by consumers, by professional workers (widespread uses), in formulation or re-packing and in manufacturing.

Consumer Uses
This substance is used in the following products: cosmetics and personal care products.

Other release to the environment of this substance is likely to occur from: indoor use as processing aid.

Article service life

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

Widespread uses by professional workers

This substance is used in the following products: cosmetics and personal care products.

ECHA has no public registered data on the types of manufacture using this substance.

This substance is used in the following activities or processes at workplace: hand mixing with intimate contact only with personal protective equipment available.

Other release to the environment of this substance is likely to occur from: indoor use as processing aid.

Formulation or re-packing
This substance is used in the following products: cosmetics and personal care products and pharmaceuticals.

This substance is used in the following activities or processes at workplace: closed batch processing in synthesis or formulation, mixing in open batch processes, transfer
of substance into small containers, laboratory work, production of mixtures or articles by tabletting, compression, extrusion or pelletisation and transfer of chemicals.

Release to the environment of this substance can occur from industrial use: formulation of mixtures.

Uses at industrial sites

ECHA has no public registered data indicating whether or in which chemical products the substance might be used.

ECHA has no public registered data on the types of manufacture using this substance.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

Manufacture
This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous
processes with occasional controlled exposure, closed batch processing in synthesis or formulation, batch processing in synthesis or formulation with opportunity for
exposure and laboratory work.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

Precautionary Measures and safe use

ECHA has no data from registration dossiers on the precautionary measures for using this substance. Guidance on the safe use of the substance provided by
manufacturers and importers of this substance.

Registrants/suppliers

Active
KIST Europe, Campus E7.1 66123 Saarbrücken Germany
[Con+dential], [Con+dential]

Inactive
Other names

IUPAC names
Ceramide (Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl])
Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-
Y3S

Regulatory processes names

Trade names
n-steoyl phytosphingosine

Other names

Scienti5c properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the
time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of
the information displayed.

Appearance/physical state / colour

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

C Physical state at 20°C and 1013 hPa Studies with data " # $ % & No data available
Solid (100%) [2]
Key study 1 1

Supporting study
C Form
Solid: crystalline (50%), Solid: particulate/powder Weight of evidence
(50%) [2]
Other
Data waiving
C Odour
Other (100%) [1] no waivers

C Substance type
Organic (100%) [2]

Melting/freezing point

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

R Melting / freezing point Studies with data " # $ % & No data available
124.6 - 126 °C @ 101.3 kPa [2]
Key study 2

Supporting study

Weight of evidence

Other
Data waiving

no waivers
Boiling point

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
1 study processed 0 summaries processed

R Boiling point Studies with data " # $ % & No data available

718 °C @ 10 hPa [1]
Key study 1 1

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Density

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

R Relative density Studies with data " # $ % & No data available

0.994 - 1.014 @ 20 °C [2]
Key study 2

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Vapour pressure

Study results 3 studies submitted Type of Study provided Summaries 0 summaries submitted
1 study processed 0 summaries processed

R Vapour pressure Studies with data " # $ % & No data available

0 Pa @ 25 °C [1]
Key study 1

Supporting study 1

Weight of evidence

Other
Data waiving

Not feasible 1

Sci. unjusti+ed

Exposure cons.

Other
Partition coeZcient

Study results 3 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

R Log Pow Studies with data " # $ % & No data available

12.01 @ 25 °C and pH 7 [2]
Key study 2

Supporting study

Weight of evidence

Other
Data waiving

Not feasible 1

Sci. unjusti+ed

Exposure cons.

Other

Water solubility

Study results 3 studies submitted Type of Study provided 1 summary submitted

R Summaries
3 studies processed 1 summary processed

R Water solubility (mass/vol.) Studies with data " # $ % Water solubility

0.01 - 10 000 000 ng/L @ 20 - 25 °C and pH 7 [3] 0.015 ng/L @ 25 °C
Key study 1 2

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Solubility in organic solvents / fat solubility

& Data not provided by the registrant

Surface tension

Study results 3 studies submitted Type of Study provided Summaries 0 summaries submitted
0 studies processed 0 summaries processed

& No automatically processable data submitted Studies with data " # $ % & No data available
Key study

Supporting study 1

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 2

Exposure cons.

Other
Flash point

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
1 study processed 0 summaries processed

R Flash point Studies with data " # $ % & No data available

254 °C @ 101.325 kPa [1]
Key study 1

Supporting study

Weight of evidence

Other
Data waiving

Not feasible 1

Sci. unjusti+ed

Exposure cons.

Other

Auto [ammability

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
0 studies processed 0 summaries processed

& No automatically processable data submitted Studies with data " # $ % & No data available
Key study

Supporting study

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 2

Exposure cons.

Other

Flammability

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

C Interpretation of results Studies with data " # $ % & No data available

Not classi+ed based on GHS criteria (50%), GHS
Key study 2
criteria not met (50%) [2]
Supporting study

Weight of evidence

Other
Data waiving

no waivers
Explosiveness

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
0 studies processed 0 summaries processed

& No automatically processable data submitted Studies with data " # $ % & No data available
Key study

Supporting study

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 1

Exposure cons.

Other 1

Oxidising

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
0 studies processed 0 summaries processed

& No automatically processable data submitted Studies with data " # $ % & No data available
Key study

Supporting study

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 1

Exposure cons.

Other 1

Oxidation reduction potential

& Data not provided by the registrant

pH

& Data not provided by the registrant

Dissociation constant

& Data not provided by the registrant

Viscosity

& Data not provided by the registrant

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to
ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the
correctness of the information displayed.
Phototransformation in air

& Data not provided by the registrant

Hydrolysis

& Data not provided by the registrant

Phototransformation in water

& Data not provided by the registrant

Phototransformation in soil

& Data not provided by the registrant

Biodegradation in water - screening tests

Study results 4 studies submitted Type of Study provided Summaries 0 summaries submitted
3 studies processed 0 summaries processed

C Interpretation of results Studies with data " # $ % & No data available

Readily biodegradable (33%), Readily biodegradable
Key study 2 1 1
but failing the 10-day window (33%), Not readily
biodegradable (33%) [3] Supporting study

Weight of evidence

Other
Data waiving

no waivers

Biodegradation in water & sediment - simulation tests

& Data not provided by the registrant

Biodegradation in soil

& Data not provided by the registrant

Bioaccumulation: aquatic / sediment

& Data not provided by the registrant

Bioaccumulation: terrestrial

& Data not provided by the registrant

Adsorption/desorption

& Data not provided by the registrant

Henrys law constant (H)

& Data not provided by the registrant

Distribution modelling

& Data not provided by the registrant

Ecotoxicological information
This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the
time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of
the information displayed.

Predicted No-Effect Concentration (PNEC)

& Data not provided by the registrant

Short–term toxicity to 5sh

& Data not provided by the registrant

Long–term toxicity to 5sh

& Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results 2 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

P/R Results Studies with data " # $ % & No data available

EC50 (48 h) 7 - 100 000 µg/L [2]
Key study 2
EL10 (48 h) 100 mg/L [1]
Supporting study

Weight of evidence

Other
Data waiving

no waivers

Long–term toxicity to aquatic invertebrates

& Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results 3 studies submitted Type of Study provided Summaries 0 summaries submitted
2 studies processed 0 summaries processed

P/R Results Studies with data " # $ % & No data available

EC50 (4 days) 77.7 ng/L [1]
Key study 1 1 1
EL10 (72 h) 100 mg/L [1]
Supporting study
NOELR (72 h) 100 mg/L [1]
Weight of evidence

Other
Data waiving

no waivers
Toxicity to aquatic plants other than algae

Study results 1 study submitted Type of Study provided Summaries 0 summaries submitted
1 study processed 0 summaries processed

P/R Results Studies with data " # $ % & No data available

IC50 (4 days) 80 ng/L [1]
Key study 1

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Toxicity to microorganisms

& Data not provided by the registrant

Sediment toxicity

& Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

& Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

& Data not provided by the registrant

Toxicity to terrestrial arthropods

& Data not provided by the registrant

Toxicity to terrestrial plants

& Data not provided by the registrant

Toxicity to soil microorganisms

& Data not provided by the registrant

Toxicity to birds

& Data not provided by the registrant

Toxicity to mammals

& Data not provided by the registrant

Toxicological information
This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of
generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the
information displayed.
Derived No- or Minimal Effect Level (DN(M)EL)

& Data not provided by the registrant

Toxicokinetics, metabolism, and distribution

& Data not provided by the registrant

Acute toxicity

Study results Type of Study provided Summaries 0 summaries submitted

0 summaries processed

oral 1 study submitted oral & No data available

1 study processed

P/R Results Studies with data " # $ %

LD50 5 000 mg/kg bw (rat) [1]
Key study 1

Supporting study
M/C Interpretations of results
GHS criteria not met [1] Weight of evidence

Other
Data waiving

no waivers

inhalation 0 studies submitted inhalation

0 studies processed

& No data available Studies with data " # $ %

Key study

Supporting study

Weight of evidence

Other
Data waiving

no waivers

dermal 2 studies submitted dermal

1 study processed

P/R Results Studies with data " # $ %

LD50 2 000 mg/kg bw (rat) [1]
Key study 1 1

Supporting study
M/C Interpretations of results
GHS criteria not met [1] Weight of evidence

Other
Data waiving

no waivers

other routes 0 studies submitted other routes

 0 studies processed

& No data available Studies with data " # $ %

Key study

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Irritation / corrosion

Study results Type of Study provided 1 summary submitted

M/C Summaries
1 summary processed

Skin
Study data: skin 3 studies submitted Study data: skin
0 studies processed No adverse effect observed (not irritating)

Eye
& Study data not processed for brief pro+le Studies with data " # $ % No adverse effect observed (not irritating)
Key study 1
Respiratory
Supporting study 1
No study available
Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 1

Exposure cons.

Other

Study data: eye 3 studies submitted Study data: eye

0 studies processed

& Study data not processed for brief pro+le Studies with data " # $ %

Key study 2

Supporting study

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 1

Exposure cons.

Other
Sensitisation

Study results Type of Study provided Summaries 0 summaries submitted

0 summaries processed

Study data: skin 3 studies submitted Study data: skin & No data available
0 studies processed

& Study data not processed for brief pro+le Studies with data " # $ %

Key study 1

Supporting study

Weight of evidence

Other
Data waiving

Not feasible

Sci. unjusti+ed 2

Exposure cons.

Other

Study data: respiratory 0 studies submitted Study data: respiratory

0 studies processed

& Study data not processed for brief pro+le Studies with data " # $ %

Key study

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Repeated dose toxicity

& Data not provided by the registrant

Genetic toxicity

Study results Type of Study provided 1 summary submitted

M/C Summaries
1 summary processed

Toxicity - InVitro
Study data: in vitro 3 studies submitted Study data: in vitro
0 studies processed No adverse effect observed (negative)

Toxicity - InVivo
& Study data not processed for brief pro+le Studies with data " # $ % No study available
Key study 1 1

Supporting study 1

Weight of evidence

Other
Data waiving

no waivers

Study data: in vivo 0 studies submitted Study data: in vivo

0 studies processed

& Study data not processed for brief pro+le Studies with data " # $ %

Key study

Supporting study

Weight of evidence

Other
Data waiving

no waivers

Carcinogenicity

& Data not provided by the registrant

Toxicity to reproduction

& Data not provided by the registrant

Neurotoxicity

& Data not provided by the registrant

Immunotoxicity

& Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

& Data not provided by the registrant

The brief pro+le is based on non-con+dential data contained in ECHA’s databases at the time of generation. Please be aware that as additional data
is submitted to ECHA, the brief pro+le will also be updated to reoect the new situation. All data remain the property of its respective owners. ECHA
Note that the brief pro+le is an automatically generated summary and that not all available data may be displayed. The content is subject to change
without prior notice. The information has not been reviewed or veri+ed by ECHA or any other authority. The Agency thus cannot guarantee the
correctness of the information displayed. The identi+cation of applicable legislative frameworks is done automatically and without manual
veri+cation. Therefore this does not constitute oIcial and legally binding information. To con+rm if a substance is covered by a speci+c legislative
framework the oIcial publication should be consulted.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the
permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take any responsibility
whatsoever for any copyright or other infringements that may be caused by using the information. This brief pro+le is covered by the ECHA Legal
Notice.