Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 September 1994 to 29 september 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to international guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SR 48941
Batch 4SNP006

Test animals

Species:
rat
Strain:
other: OFA-SD (IOPS Caw)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Each group was composed of 5 animals of the sale sex. Animals were subjected to clinical examination and selected if they were in good health. The animals were assigned manually to the experimental group and identified by tattoo according to the Standard Operating Procedures.
- Source: Iffa Credo
- Age at study initiation: approximately 5 weeks old
- Weight at study initiation: 135 to 153 grams for males and 119 to 135 grams for females.
- Housing: Rats were housed 2 or 3 of the same group to stainless steel cages (891 cm² x 18 cm).
- Diet (e.g. ad libitum):free access to UAR AO4C. Food was withdrawn 18 hours before treatment and redistributed approximatly 4 hours after gavage.
- Water (e.g. ad libitum): tap water
- Acclimation: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (+/- 2°C)
- Relative Humidity (%): 40-70 %
- Air changes (per hr): air was renewed 10 to 11 times per hour without recycling.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.6% methylcellulose aqueous solution
Doses:
0 and 2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females per group
Control animals:
yes
Details on study design:
Animals were kept under observation for 15 days following administration. During this period, clinical signs and cases of mortality were recorded.
A study of body weight changes was performed by weighing the animals on the day of treatment (D1), then on D3, D8 and D15.
Post-mortem macroscopic examination was performed in the animals found dead during the study. Lethal dose values were calculated, when possible, after mortality 15 days following treatment.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality recorded
Clinical signs:
No abnormality detected
Body weight:
No abnormality detected
Gross pathology:
No abnormality detected

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dose level of 2000 mg/kg was non lethal (with LD50 > 2000 mg/kg), and did not induce adverse effects in rats of either sex.