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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:
08 - 23 Jan 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(2004)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Groupe interministeriel des produits chimiques, Paris, France
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: fluid gel, not further specified

Test animals

Species:
rat
Strain:
other: Sprague Dawley-SPF Caw
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest St. Isle, France
- Age at study initiation: eight weeks
- Weight at study initiation: 180 - 200 g
- Fasting period before study: from Day -1 to 4 h after the test administration
- Housing: in groups of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; sawdust bedding.
- Diet: foodstuff, ad libitum (except during the fasting period)
- Water: tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 32 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.78 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (females)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on Day 0 (just before administration) and on Days 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423 may be considered higher than 5000 mg/kg bw.
Mortality:
No mortality occurred during the study period.
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 and was 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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

The test material was investigated for acute oral toxicity according to the OECD TG 423, and in compliance with GLP. The test material (57.2 a.i.) was administered once via oral gavage to 6 female Sprague-Dawley rats at a dose of 2000 mg/kg bw. No mortality occurred and no signs of systemic toxicity were observed throughout the study period. Based on these findings, classification for acute oral toxicity according to Regulation (EC) No 1272/2008 is not warranted.