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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 March to 05 April 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study conducted in compliance with OECD Guideline No. 423 with minor deviations: age at study initiation, housing and feeding conditions, details of fasting not reported. These deviations do not affect the quality of the study and are not considered to be relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
age at study initiation, housing and feeding conditions, details of fasting not reported
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
13 December 2005
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Source and lot/batch No.of test material: MANE FILS SA / 713060- Physical state: Colourless liquid- Date received: 13 March 2006- Expiration date of the lot/batch: February 2007- Purity test date: February 2006- Test item was considered at 100% for the study.- Name of test material (as cited in study report): Figolide A45240- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Elevage JANVIER (53940 Le Genest St Isle, France.- Weight at study initiation: 208-228 g- Fasting period before study: No data- Housing: No data- Diet: No data- Water: No data- Acclimation period: 5 days ENVIRONMENTAL CONDITIONS - Temperature: 21-23 °C - Humidity: 38-60 % IN-LIFE DATES: 21 March to 05 April 2006

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
ADMINISTRATION: Animals received an effective dose of 2000 mg/kg bw of the test item, administered by force-feeding under a volume of 1.95 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.MAXIMUM DOSE VOLUME APPLIED: 1.95 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations: Clinical observations were performed 30 minutes, 1, 3 and 4 h after test substance administration, and once daily thereafter for 14 days. - Frequency of weighing: Body weights were observed on Days 0, 2, 7 and 14.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred during the study.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the criteria of the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw administered by force-feeding under a volume of 1.95 ml/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No clinical signs related to the administration of the test substance were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. In this study, the oral LD50 of test substance was considered to be higher than 2000 mg/kg bw in female rats.

 

Under the test conditions, the test substance is not classified for acute oral toxicity according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.