Part A – Core Registration Report

Assessment
Page 13 of 78

toxicity risk to birds is expected to results from applications of GIBER GOBBI 10 at all proposed label
rates.

Risk assessment through drinking water

According to the Guidance of EFSA, Risk Assessment for Birds and Mammals (2009)5, only the puddle
scenario is relevant for long term risk assessement. The TER value is presented in Table 10.1.2-3.
Table 10.1.2-3: TER value through drinking water – Puddle scenario
DWR for small Calculated
Concentration Organic adsorption Application PEC Annex VI
granivorous NOEC
of the spray coefficient – KOC rate puddle
birds acceptable
solution (g/L) (mL/g) (mg/m²) (mg/L) TERLT (mg a.s./kg
(L/kg bw/d) bw/day)
Fruiting vegetables and leafy vegetables
0.05 7.1 2 0.09788 0.46 5 0.23
Vineyard
0.10 7.1 3 0.16639 0.46 5 0.38
Orchards
0.02 7.1 2 0.06525 0.46 5 0.15
Note: calculations conducted using the spreadsheet provided by EFSA at: http://www.efsa.europa.eu/en/scdocs/scdoc/1438.htm

The Tier 1 long-term exposure estimate through drinking water would require a long-terme NOEC of less
than 0.38 mg a.s./kg bw/day to be below the Annex VI trigger of 5. Since it is very unlikely, no
unacceptable long term risk to birds is expected to result through drinking water following applications of
GIBER GOBBI 10 at all proposed label rates.

Review -
Comments:
IIIA 10.1.2
Agreed The long-term risk to birds is acceptable on the basis of weight-of-evidence (EFSA
endpoints: review report).
IIIA 10.1.2

IIIA 10.1.3 Baits: Concentration of active substance in bait in mg/kg

GIBER GOBBI 10 is intended for use as a foliar spray, and therefore this information is not required.

IIIA 10.1.4 Pellets, granules, prills or treated seed

GIBER GOBBI 10 is intended for use as a foliar spray, and therefore this information is not required.

IIIA 10.1.4.1 Amount of active substance in or on each item

GIBER GOBBI 10 is intended for use as a foliar spray, and therefore this information is not required.

IIIA 10.1.4.2 Proportion of active substance LD50 per 100 items and per gram of items
GIBER GOBBI 10 is intended for use as a foliar spray, and therefore this information is not required.

5
Guidance of EFSA: Risk Assessment for Birds and Mammals. European Food Safety Authority (EFSA), Parma, Italy, EFSA
Journal 2009; 7(12):1438
Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18
Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 14 of 78

IIIA 10.1.5 Size and shape of pellet, granule or prill

GIBER GOBBI 10 is intended for use as a foliar spray, and therefore this information is not required.

IIIA 10.1.6 Acute toxicity of the formulation

Avian toxicity tests with the formulation were not performed, since it is possible to extrapolate from data
obtained with the active substance.

IIIA 10.1.7 Supervised cage or field trials

The risk assessment above demonstrated that the proposed use of GIBER GOBBI 10 poses no
unacceptable to birds, and therefore further studies are not considered necessary.

IIIA 10.1.8 Acceptance of bait, granules or treated seeds (palatability testing)

The information concerned is not relevant since GIBER GOBBI 10 is intended for use as a foliar spray.

IIIA 10.1.9 Effects of secondary poisoning

Gibberellic acid has a log POW value of 0.72 at pH 7. Given that the log Pow is less than 3 it is considered
that there is no potential for bioaccumulation of GA3 in fatty tissues and therefore it is not necessary to
consider the risk from secondary poisoning further. Therefore, based on the low log POW values the risk
from bioaccumulation to fish-eating and worm-eating birds is negligible.

Review -
Comments:
IIIA 10.1.9
Agreed Gibberellic acid has a log POW value of less than 3 (0.72). Therefore, it is
endpoints: considered that there is no potential for bioaccumulation of GA3 in fatty tissues.
IIIA 10.1.9

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 15 of 78

IIIA 10.2 Effects on Aquatic Organisms

EU Endpoints: Ecotoxicological endpoints for aquatic species
EU agreed endpoints
Active substance Test species1
(EFSA Journal 2012;10(1):2507)
Acute toxicity to fish
Gibberellic acid Cyprinus carpio 96 h LC50 > 100 mg a.s./L
Chronic toxicity to fish
Gibberellic acid No data provided
Acute toxicity to aquatic invertebrates
Gibberellic acid Daphnia magna 48 h EC50 > 76 mg a.s./L
Chronic toxicity to aquatic invertebrates
Gibberellic acid No data provided
Toxicity to green algae
Pseudokirchneriella 72 h EbC50 > 17 mg a.s./L
Gibberellic acid
subcapitata 72 h ErC50 > 25 mg a.s./L
Toxicity to aquatic plants
Gibberellic acid No data provided
Mesocosm
Gibberellic acid Not required
1
enter end-point for the critical species only

Summary
Effects on aquatic organisms for GIBER GOBBI 10 were not evaluated as part of the EU review of
Gibberellic acid. Data on GIBER GOBBI 10 is evaluated here, and risk assessments for GIBER GOBBI
10 with the proposed use pattern are provided here and are considered adequate.

Revised PECsw are provided in Part B, Section 5, point 9.7. Full details are provided in that section of
how the PECsw are calculated. The global maximum PECsw was from one application and so this is
used in the risk assessment.

The table below summarises the TERs for all the relevant organisms.

Table 10.2-1 Toxicity data for aquatic species (most sensitive species of each group)
Test PEC TER risk
Organism Toxicity endpoint TER
substance (μg/L) assessment trigger
Cyprinus carpio 96 hr LC50 > 100 000 μg/L > 4 669 100
Gibberellic Daphnia magna 48 hr EC50 > 76 000 μg/L > 3 548 100
21.4180
acid Pseudokirchneriella
72 hr EbC50 > 17 000 μg/L > 793 10
subcapitata
Pseudokirchneriella
GIBER 72 hr EyC50 = 137 550 μg/L* 13 120 10
subcapitata 10.48
GOBBI 10
lemna minor 7-day EC50 = 925 290 μg/L* 88 291 10
* Toxicity endpoints taken from the studies performed with GIBER GOBBI 20

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 16 of 78

All the TER values are above the Annex VI triggers indicating that application of GIBER GOBBI 10
according to the proposed label uses poses low risk to aquatic organisms.

Review Considering the composition of the products GIBER GOBBI 10 and GIBER
Comments: GOBBI 20 (see Part C), it can be concluded that the two products are similar from
IIIA 10.2 to ecotoxicological point of view. Studies generated for GIBER GOBBI 20 are used
IIIA 10.2.7 in the risk assessment of the product GIBER GOBBI 10.
Agreed
endpoints:
IIIA 10.2 to
IIIA 10.2.7

Toxicity
A summary of the toxicity data for all aquatic organisms used in the risk assessment is provided in Table
10.2-4. Further details of the studies on the active substance are provided in the Gibberellic acid EU
review.

No studies were performed with the formulation GIBER GOBBI 10 since studies with a similar
formulation GIBER GOBBI 20 were already available.
The formulation GIBER GOBBI 10 has the same composition as GIBER GOBBI 20, with a lower active
substance content (10% w/w instead of 20% w/w). Please refer to the detailed compositions provided in
the Part C, point IIIA 1.4.1.
As generally the toxicity appears to be primarily influenced by the active substance, it is deemed
acceptable to consider that the studies with GIBER GOBBI 20 are adequate to predict the potential
ecotoxicity of the formulation GIBER GOBBI 10.
Details regarding the tests with the product GIBER GOBBI 20 are provided in section 10.2-5.

Table 10.2-4: Summary of the toxicity values of Gibberellic acid for aquatic organisms
Organism Test substance Endpoint Value Reference
Fish
EFSA Journal
Cyprinus carpio Gibberellic acid 96h LC50 > 100 mg a.s./L
2012;10(1):2507
Aquatic invertebrates
EFSA Journal
Daphnia magna Gibberellic acid 48h EC50 > 76 mg a.s./L
2012;10(1):2507
Algae
72h EbC50 > 17 mg a.s./L EFSA Journal
Gibberellic acid
72h ErC50 > 25 mg a.s./L 2012;10(1):2507
Pseudokirchneriella 72h ErC50 296.90 mg/L KIIIA1
subcapitata GIBER GOBBI 20
10.2.2.3/01,
72h EyC50 137.55 mg/L Sabrina
Mantilacci, 2013
Aquatic macrophytes
fronds number:
7-day ErC50 1337.03 mg/L
KIIIA1
7-day EyC50 925.29 mg/L
10.8.2.1/01,
Lemna gibba GIBER GOBBI 20
Sabrina
dry weight:
Mantilacci, 2013
7-day ErC50 1242.30 mg/L
7-day EyC50 954.37 mg/L
In bold, values used for the risk assessment

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili
 Part A – Core Registration Report
Assessment
Page 17 of 78

The results from the tests using the formulation indicate that the toxicity of the formulation reflects the
toxicity of the constituents. Generally the toxicity appears to be primarily influenced by the active
substance (Gibberellic acid).

The results from the active substance studies on fish and daphnia magna show no sign of toxicity and
therefore algae represents the most sensitive species for the active substance Gibberellic acid.

Therefore, the formulation GIBER GOBBI 10 was tested on algae and the results show no sign of toxicity
with a NOEC of 50 mg/L and a 72h day EyC50 of 137.55 mg/L (corresponding to 10.45 mg a.s./L and
28.75 mg a.s./L respectively). The corresponding TER value was equal to 13 120 and is well above the
trigger of 10.
In this context, further tests on fish and dapnia magna with the formulation GIBER GOBBI 10 were not
considered necessary since it is expected that the coformulants in GIBER GOBBI 10 do not increase the
toxicity of the active substance and therefore it is deemed acceptable to extrapolate from data with the
active substance. The calculated TER values based on the end-points from studies with the active
substance result in excessive margins of safety, therefore further data on the formulated product are not
considered necessary to ensure safety to aquatic organisms.

Tests with gastropod molluscs and insects other than sediment dwellers are not required. GIBER GOBBI
10 is not intended for direct application in water bodies.

Metabolites of Gibberellic acid

No data are available on metabolites of Gibberellic acid in water. However, gibberellic acid (GA3) and its
degradation or reaction products are naturally-occurring compounds. It is highly unlikely that any
metabolite would show increased toxicity compared to the parent compound. Therefore no further
evaluation of metabolite toxicity is considered necessary.

Exposure
Aquatic organisms may be exposed to GIBER GOBBI 10 and Gibberellic acid through spray drift, run-
off and drainage from the application site into adjacent water bodies. Exposure of aquatic organisms
from these routes was estimated by calculating Predicted Environmental Concentrations in surface water
(PECSW) (see Part B, Section 5).
As recommended, the risk envelope approach was used for calculating these PECSW and the risk
assessment for aquatic organisms according to the guidance document SANCO/11244/2011 rev. 5.

GIBER GOBBI 10
Due to the differing and unknown dissipation times of the constituents of GIBER GOBBI 10 in aquatic
systems, it was only possible to calculate the maximum instantaneous PECSW value from entry through
spray-drift that occurred immediately after a single application. The PECSW was calculated using the
following equation:

% Drift u Applicatio n rate ( g / ha )

PEC SW ( Pg/L) = 90th %ile

Water depth (cm) u 10

Applicant Document ID - 4522***_F dRR GIBBER GOBBI 10 Evalud: Date : 12 /18

Applicant Author: F. Khalili