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Agreed The risk to bees (oral and contact exposure) is acceptable.

endpoint/s:
IIIA 10.4.1

IIIA 10.4.1.1 Oral exposure QHO

Please see Point 10.4.1 above.

IIIA 10.4.1.2 Contact exposure QHC

Please see Point 10.4.1 above.

IIIA 10.4.2 Acute toxicity of the formulation to bees

IIIA 10.4.2.1 Oral

No bee acute oral study was performed with GIBER GOBBI 10 since a study with a similar formulation
GIBER GOBBI 20 was already available which is provided in support of the assessment.

Report: KIIIA1 10.4.2.1/01, Mr. S. Kimmel, 2013

Title: GIBER GOBBI 20: Acute Oral and Contact Toxicity to Honey Bees (Apis mellifera L.)
Document No: D78237
Guidelines: EPPO 23 and OECD 213
GLP Yes

Material and Methods:

GIBER GOBBI 20 (batch No. 404130425) is a white soluble tablet containing Gibberellic acid (Nominal
content: 200 g/kg; measured content: 209 g/kg).
Each treatment consisted of 4 replicates with 10 bees each. Therefore, a total of 40 bees per GIBER
GOBBI 20 treatment, reference item treatment, and control were set up.
A single concentration of 115 μg a.i./bee, referring to 550 μg product/bee was tested (limit-test, based on
the active content of 20.9%). Doses above nominal 115 μg a.i./bee were not tested in accordance with the
test guidelines. Parallel to the test item treatment, one control and 3 reference item treatments were run.
According to the test guideline, the intended dose should be offered to the bees in a volume of 20 μL 50%
(w/v) sugar solution/bee resulting in a total volume of 200 μL per 10 bees corresponding to one replicate.
In order to achieve a volume consumption of 200 μL, a surplus of 50 μL was added to the Eppendorf vial
serving as food container. Therefore, 250 μL were actually provided to 10 bees. The weights of the
Eppendorf vials including the treatment solutions were recorded before offering the treatments and after a
maximum of 6 hours, when they were consumed, to calculate the total food consumption and the effective
treatment dose per bee. Thereafter, the food was replaced with untreated 50% (w/v) sugar solution, which
was provided ad libitum for the remaining test period.
The application solution of the single dose of GIBER GOBBI 20 was prepared by dissolving 1.37 g of
GIBER GOBBI 20 homogeneously in 50 mL sugar solution (50% w/v) in an Erlenmeyer flask, which
was thoroughly shaken.
The bees were monitored for 48 hours after application of the treatments. The reference item treatments
were only observed up to the 24 hour assessment.

Findings:

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x After 48 hours, two bees had died in the control.

x In the GIBER GOBBI 20 treatment of 106 Pg a.i./bee (ingested dose), referring to 507 μg
product/bee, three bees had died after 48 hours, resulting in a mean corrected mortality of 2.6%.
Therefore, no statistically significant mortality was found at the GIBER GOBBI 20 treatment of
106 Pg a.i./bee, referring to 507 μg product/bee, since mean mortality was within the natural
range of 10% set as validity criterion for control mortality. As the corrected mortality in the
GIBER GOBBI 20 treatment does not exceed 50%, the LD50 was determined directly from the
raw data to be >106 Pg a.i./bee, referring to 507 μg product/bee.
x No behavioral effects were observed up to 48 hours after test initiation.
x In the reference item treatments, corrected mortality at the 24-hour assessment was 7.9% at the
lowest ingested dose of 0.033 μg, 42% at 0.086 μg and 100% at the highest ingested dose of
0.32 μg dimethoate/bee.
x The oral 24-hour LD50 of the reference item was calculated to be 0.10 μg dimethoate/bee.
Therefore, the performance criteria were met, as the oral LD50 at the 24-hour assessment in the
reference item treatments was in the required range of 0.10-0.35 μg a.i./bee.

Conclusion/endpoint:
Under the experimental conditions, the LD50 of GIBER GOBBI 20 was determined to be higher than
106 Pg a.i./bee (ingested dose), referring to 507 μg product/bee.

Study The study is acceptable.

Comments:
IIIA 10.4.2.1/01 The humidity was below the acceptable range for a short period of time due to
technical error. This deviation in humidity is not considered to have an influence
on biological results.

Agreed 48-h LD50 > 106 Pg a.s/bee (oral)

endpoint/s:
IIIA 10.4.2.1 48-h LD50 > 115 Pg a.s/bee (contact)

IIIA 10.4.2.2 Contact

No bee acute contact study was performed with GIBER GOBBI 10 since a study with a similar
formulation GIBER GOBBI 20 was already available which is provided in support of the assessment.

Report: KIIIA1 10.4.2.2/01, Mr. S. Kimmel, 2013

Title: GIBER GOBBI 20: Acute Oral and Contact Toxicity to Honey Bees (Apis mellifera L.)
Document No: D78237
Guidelines: EPPO 23 and OECD 214
GLP Yes

Material and Methods:

GIBER GOBBI 20 (batch No. 404130425) is a white soluble tablet containing Gibberellic acid (Nominal
content: 200 g/kg; measured content: 209 g/kg).

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Each treatment consisted of 4 replicates with 10 bees each. Therefore, a total of 40 bees per GIBER
GOBBI 20 treatment, reference item treatment, and control were set up.
A single concentration of 115 μg a.i./bee referring to 550 μg product/bee, was tested (limit-test, based on
the active content of 20.9%). Doses above nominal 115 μg a.i./bee were not tested in accordance with the
test guidelines. Parallel to the GIBER GOBBI 20 treatment, one control and 3 reference item treatments
were run.
One droplet with the volume of 1 μL of the application solution was placed on the dorsal side of the bee
thorax using a calibrated micro-pipette. Bees were anaesthetized with carbon dioxide before treatment.
Topical applications were made in the order of control, GIBER GOBBI 20 treatment and reference item
treatments in the order of ascending concentration.
The application solution of the single dose of GIBER GOBBI 20 was prepared by dissolving 5.48 g of
GIBER GOBBI 20 homogeneously in 10 mL deionized water (with 0.2% Etalfix Pro) in an Erlenmeyer
flask, which was thoroughly shaken. One μL of this application solution was applied per bee
corresponding to 115 μg/bee.
The bees were monitored for 48 hours after application of the treatments. The reference item treatments
were only observed up to the 24 hour assessment.

Findings:
x Up to 48 hours after test initiation, a mortality of 7.5% occurred in the control. The validity
criterion was met, as mortality in the control did not exceed 10% 48 hours after test initiation.
x The corrected mortality in the GIBER GOBBI 20 treatment was 0.0%. Since the corrected
mortality in the GIBER GOBBI 20 treatment does not exceed 50%, the LD50 was determined
directly from the raw data to be >115 Pg a.i./bee, referring to 550 μg product/bee.
x No behavioral effects were observed up to 48 hours after test initiation.
x In the reference item treatments, the corrected mortality at the 24-hour assessment was 5.4 and
16% at the two lower doses of 0.033 and 0.10 μg dimethoate/bee, respectively, and was 86% at
the highest dose of 0.30 μg dimethoate/bee.
x The contact 24-hour LD50 of the reference item was calculated to be 0.16 Pg dimethoate/bee.
Therefore, the performance criteria were met, as the contact LD50 at the 24-hour assessment in the
reference item treatments was in the range of 0.10-0.30 Pg a.i./bee .

Conclusion/endpoint:
Under the experimental conditions, the LD50 of GIBER GOBBI 20 was determined to be higher than
115 Pg a.i./bee, referring to 550 μg product/bee.

Study The study is acceptable.

Comments:
IIIA 10.4.2.1/01 The humidity was below the acceptable range for a short period of time due to
technical error. This deviation in humidity is not considered to have an influence
on biological results.

Agreed 48-h LD50 > 106 Pg a.s/bee (oral)

endpoint/s:
IIIA 10.4.2.1 48-h LD50 > 115 Pg a.s/bee (contact)

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IIIA 10.4.3 Effects on bees of residues on crops

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.4 Cage tests

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.5 Field tests

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.6 Investigation into special effects

IIIA 10.4.6.1 Larval toxicity

. As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.6.2 Long residual effects

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.6.3 Disorienting effects on bees

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

IIIA 10.4.7 Tunnel tests

As GIBER GOBBI 10 does not pose an unacceptable risk to honey-bees, further tests are not necessary.

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IIIA 10.5 Effects on Arthropods Other Than Bees

EU Endpoints: Effects on Arthropods
Ecotoxicological endpoints for Arthropods
Species EU agreed endpoints
Active substance
(EFSA Journal 2012;10(1):2507)
Acute
Aphidius colemani LR50 > 10 g a.s./ha
Gibberellic acid Chrysoperla carnea LR50 > 10 g a.s./ha
Orius strigicollis LR50 > 10 g a.s./ha
Sub-lethal
Gibberellic acid No data provided

Summary
Effects on arthropods other than bees of GIBER GOBBI 10 were not evaluated as part of the EU review
of Gibberellic acid. Therefore all relevant data and assessments are provided here and are considered
adequate.

able 10.5-1 Effects on other arthropod species

Test Endpoint PER PER off- HQ in- HQ off-
Species Test type
substance (g formulation/ha) in-field field field field
Aphidius Laboratory
LR50 = 1108* 0.46 0.04
GIBER rhopalosiphi Conditions
510 4.1
GOBBI 10 Typhlodromus Laboratory
LR50 = 765* 0.67 0.05
pyri Conditions
* Toxicity endpoint taken from the studies performed with GIBER GOBBI 20

Toxicity
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.

The toxicity of GIBER GOBBI 20 to non-target arthropods has been investigated. The testing and risk
assessment strategy used here follow the approach recommended in the ESCORT 2 guidance document
(Candolfi et al. 2001)10 and the EC Guidance Document on Terrestrial Ecotoxicology 11.

10
Candolfi MP, Barrett KL, Campbell PJ, Forster R, Grandy N, Huet M-C, Lewis G, Oomen PA, Schmuck R, Vogt
H (2000) ‘Guidance Document on regulatory testing procedures for plant protection products with non-target
arthropods’ From the workshop, European Standard Characteristics of Non-target Arthropod Regulatory Testing
(ESCORT 2) 21-23 March 2000.
11
EC Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC, SANCO/10329, 17
October 2002.
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