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IIIA 10.2.5.2 Fish early life stage test

Not required.

IIIA 10.2.5.3 Fish life cycle test

Not required.

IIIA 10.2.6 Chronic toxicity to aquatic invertebrates

No data submitted for chronic toxicity to daphnia.
Gibberellins, including GA3 are naturally occurring compounds in the wider environment, being found in
plant tissues, fungal species and bacteria. Gibberellins are reported in plants at up to 10 mg/kg fresh
weight, production by bacteria has been found at levels of 0.01-1.0 mg GA3 equivalents per litre. Some
fungal species, including excrete large amounts of gibberellin in the region of mg/L levels. In addition,
hydrolytic data showed that degradation of GA3 was rapid.
Due to these facts it is considered that chronic exposure of aquatic organisms resulting from the proposed
use of GA3 will be insignificant. Based on the lack of significant chronic exposure and the low acute
toxicity of GA3 to daphnia it is considered that there will be no chronic risk to daphnia from the proposed
uses of GA3 and therefore chronic daphnia toxicity data are not required.

IIIA 10.2.6.1 21 day test (Daphnia magna)

Not required.

IIIA 10.2.6.2 Aquatic insect

Not required.

IIIA 10.2.6.3 Aquatic gastropod mollusc

Not required.

IIIA 10.2.7 Accumulation in aquatic non-target organisms

Bioaccumulation of any of the active substances under natural conditions is not expected to occur (refer
to Section 10.2.4), and a study is not necessary to determine bioaccumulation in aquatic non-target
organisms.

Study The justification is acceptable.

Comments:
IIIA 10.2.7/01

Agreed
endpoint/s:
IIIA 10.2.7

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IIIA 10.3 Effects on Terrestrial Vertebrates Other Than Birds

Overview and summary

EU Endpoints: Effects on Terrestrial Vertebrates Other Than Birds

Ecotoxicological endpoints for mammals
EU agreed endpoints
Active substance Test species1
(EFSA Journal 2012;10(1):2507)
Acute
Gibberellic acid Rat LC50 > 5000 mg/kg bw
Chronic
Gibberellic acid Rat, Rabbit NOEL = 1000 mg/kg bw/day2
1
enter end-point for the critical species only
2
Highest dose tested in the rabbit developmental study

Summary
The effects on terrestrial vertebrates other than birds for GIBER GOBBI 10 were not evaluated as part of
the EU review of Gibberellic acid. However further data on GIBER GOBBI 10 is not relevant as active
substance data on toxicity to terrestrial vertebrates other than birds is used and additional formulation data
are not considered essential. Therefore all relevant data were assessed in the EU review. Risk assessments
for GIBER GOBBI 10 with the proposed use pattern are provided here and are considered adequate.

Risk assessment
Toxicity
The mammalian toxicity endpoints for Gibberellic acid that are most appropriate for acute and long-term
ecological risk assessment are summarised in Tables 10.3-2 and 10.3-3. In addition the acute mammalian
endpoint of GIBER GOBBI 10 is also provided and the result is reported below. Further details can be
found in the corresponding EU review for each of the Gibberellic acid, and Part B, Section 3.

Table 10.3-2: Acute oral toxicity to mammals

Value
Substance Species Endpoint Report
(mg/kg bodyweight)
KIIIA1 7.1.1/01, A
GIBER GOBBI 10 Rat LD50 > 2000
Sanders, 2013
(EFSA Journal
Gibberellic acid Rat LD50 > 5000
2012;10(1):2507)
Lowest acute endpoints shown in bold are used in the risk assessment

Table 10.3-3: Reproductive toxicity to mammals

Study Value
Substance Species Report
Endpoint (mg a.s./kg bw/d)
Gibberellic Developmental study: (EFSA Journal
Rabbit 1000
acid NOEC 2012;10(1):2507)

Exposure
Mammals are typically exposed to dry residues on their food items following the dilution and spraying of
the formulated product. During these processes, much of the formulation constituents are likely to be lost

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by volatilisation. Therefore, where oral exposure is the main route of exposure, toxicity data for the active
substance are used in preference to data from tests with the formulated material. Exposure to GIBER
GOBBI 10 via dermal and inhalation routes is considered unlikely, since at the time of application and for
a short period thereafter, most wild mammals will leave the immediate vicinity of spray operations in
response to the human disturbance.

IIIA 10.3.1 Toxicity exposure ratios

IIIA 10.3.1.1 Acute toxicity exposure ratio (TERA)

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)6, a screening
assessment was performed as the first stage in risk assessment. In screening assessment the ‘daily dietary
dose’ (DDD) is calculated by multiplying the rate of application of the product (expressed as kg as/ha) by
the short-cut value (SV) according to formula:

DDDsingle application = application rate (kg as/ha) x SV

The SV is a default value for the species of concern (i.e. the indicator species, the generic focal species or
the focal species), derived according to formula:

SV= FIR/bw x RUD

Where: FIR: food intake rate
bw: body weight
RUD: residue per unit dose

Indicator species relevant for the intended uses and SV values are presented in the Table 10.3.1-1.

Table 10.3.1-1. Acute shortcut values (based on 90th percentile residues) for mammalian indicator
species
Shortcut value
Crop Corresponding crop group Indicator species for acute
assessment
Cotton, fruiting vegetables, grassland, leafy
Pear, cherry and Small herbivorous
vegetables, legume forage, maize, orchards, 136.4
citrus mammal
ornamentals/nursery, pulses, and vineyard
Cotton, fruiting vegetables, grassland, leafy
Small herbivorous
Grape vegetables, legume forage, maize, orchards, 136.4
mammal
ornamentals/nursery, pulses, and vineyard
Cotton, fruiting vegetables, grassland, leafy
Tomato, eggplant Small herbivorous
vegetables, legume forage, maize, orchards, 136.4
and artichokes mammal
ornamentals/nursery, pulses, and vineyard

For multiple applications, the DDD for single application is multiply by an appropriate multiple
application factor for 90th percentile reside data (MAF):

DDDmultiple applications = DDDsingle application x MAF

6
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438

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As recommended, the risk envelope approach was used for the risk assessment for birds according to the
guidance document SANCO/11244/2011 rev. 5.

Rationale for crop groupings

Following the procedure above, the key parameters for the first tier assessment are the application rate,
the number of application and application interval and the shortcut values depending on the generic focal
species.

The crop grouping covering the worst case scenario is presented in the table 10.3.1-2.

Table 10.3.1-2: Summary of crop grouping for the risk envelope approach
Maximum
Maximum number Interval
Crop group Crops included application rate MAF
of applications (days)
[g as/ha]
Pear 12 1 - -
Orange, lemon,
20 1 - -
Orchards cherry
Clementine,
10 2 7 1.4
mandarin
Vineyard Grapes 30 2 5 1.5
Fruiting Tomato, eggplant 10 3 7 1.6
vegetables and
leafy vegetables Artichoke 20 3 15 1.3
In bold, worst case scenario considered for risk assessment

Screening Step
The acute risk assessment for the use of GIBER GOBBI 10 is presented in Table 10.3.1-3.

Table 10.3.1-3: Acute risk (TERA) to mammals from Gibberellic acid

LD50 Multiple Daily
Shortcut App. rate
Crop group (mg a.s./kg MAF Dietary Dose TERA
value (kg a.s./ha)
bw/day) (mg a.s./kg bw/day)
Orchards 136.4 0.020 - 2.73 1832.8
Vineyard 136.4 0.030 1.5 6.14 814.6
Fruiting > 5 000
vegetables and 136.4 0.020 1.3 3.55 1409.9
leafy vegetables
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The TERA values are greater than the Annex VI trigger of 10, indicating low acute risk to mammals from
Gibberellic acid following application of GIBER GOBBI 10 at all proposed label rates.

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Risk assessment through drinking water

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)7, the leaf scenario
is only relevant for leaf vegetables whereas the puddle scenario is relevant for all the intended uses of
GIBER GOBBI 10. The TER value is presented in Table 10.3.1.1-4 and 10.3.1.1-5.
Table 10.3.1.1-4: TER value through drinking water – Leaf scenario
DWR for small
Concentration Organic adsorption Application LD50 PEC
granivorous
of the spray coefficient – KOC rate (mg a.s./kg pool TERA
mammals
solution (g/L) (mL/g) (mg/m²) bw) (mg/L)
(L/kg bw/d)
Fruiting vegetables and leafy vegetables
0.05 7.1 2 5000 10 0.24 2083.3
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Table 10.3.1.1-5: TER value through drinking water – Puddle scenario

DWR for small
Concentration Organic adsorption Application LD50 PEC
granivorous
of the spray coefficient – KOC rate (mg a.s./kg puddle TERA
mammals
solution (g/L) (mL/g) (mg/m²) bw) (mg/L)
(L/kg bw/d)
Fruiting vegetables and leafy vegetables
0.05 7.1 2 5000 0.09788 0.24 212847
Vineyard
0.10 7.1 3 5000 0.16639 0.24 125204
Orchards
0.02 7.1 2 5000 0.06525 0.24 319271
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The TERA values through drinking water are well above the Annex VI trigger of 10, indicating a low
acute risk to mammals from Gibberellic acid following application of GIBER GOBBI 10 at the proposed
label rate.

Review Risk assessment from dietary exposure

Comments:
IIIA For screening step calculations of Table 10.3.1-3 the EU agreed endpoint was used. The
10.3.1.1 risk is acceptable even when the acute mammalian endpoint of GIBER GOBBI 10
(KIIIA1 7.1.1/01, A Sanders, 2013) is considered:

LD50 Multiple Daily

App. rate
(mg Shortcut Dietary Dose
Crop group (kg MAF TERA
a.s/kg value (mg a.s/kg
a.s/ha)
bw/day) bw/day)
Orchards 136.4 0.020 - 2.73 153.1
> 418
Vineyard 136.4 0.030 1.5 6.14 68.1

7
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438

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Fruiting
vegetables
136.4 0.020 1.3 3.55 117.7
and leafy
vegetables

Risk assessment from exposure through drinking water consumption

Puddle scenario: According to the Guideline for Birds and Mammals, no specific
calculations of exposure and TER are necessary when the ratio of maximum effective
application rate to the worst case toxicity endpoint does not exceed 50 for less sorptive
substances. Ratio calculations are provided below:

Maximum
Time Test effective Trigger
Endpoint Ratio
scale substance application value
rate*
30*1.21 g LD50 > 418 mg
Acute GA3 < 0.09 50
a.s/ha a.s/kg bw
* MAFm based on soil DT50 of 5 days

Leaf scenario: The leaf scenario is not relevant for small mammals
Agreed The risk to mammals from dietary acute exposure is acceptable.
endpoints:
IIIA The risk from exposure via intake of contaminated drinking water is acceptable.
10.3.1.1

IIIA 10.3.1.2 Short-term toxicity exposure ratio (TERST)

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)7, the short-term
risk to mammals is is generally no longer required since it is assumed as a default that the effects are
caused by long term exposure.

IIIA 10.3.1.3 Long-term toxicity exposure ratio (TERLT)

The long-term risk to wild mammals was assessed from long-term TER values, calculated according to
the EFSA Guidance (2009)7.

Indicator species relevant for the intended uses and SV values are presented in the Table 10.3.1.3-1.

Table 10.3.1.3-1: Indicator species and shortcut values (based on mean residues) for the
mammalian reproductive assessment.
Shortcut value
Crop Corresponding crop group Indicator species for acute
assessment
Cotton, fruiting vegetables, grassland, leafy
Pear, cherry and Small herbivorous
vegetables, legume forage, maize, orchards, 72.3
citrus mammal
ornamentals/nursery, pulses, and vineyard
Small herbivorous
Grape Cotton, fruiting vegetables, grassland, leafy 72.3
mammal

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