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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:
From 24 SEP 1974 to 8 OCT 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF breeding colony
- Weight at study initiation: mean 91 g
- Fasting period before study: 16 h
- Housing: plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% suspension in vehicle
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Remarks on result:
other: 3 animals died within 175 to 245 minutes post application without any visible signs of toxicity
Mortality:
- 3 animals died within 175 to 245 min after the application
- the remaining 7 animals survived the observation period
Clinical signs:
- faeces and urine were yellow-coloured
Body weight:
- body weight development of the remaining animals was not impaired
Gross pathology:
- the deceased animals during the test as well as the animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The testing for acute oral toxicity yielded a median lethal dose (LD50) of > 15000 mg test substance per kg bw in female rats.
Executive summary:

Female rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest applicable dose of 15000 mg/kg bw. Three animals died at this dose within 4 hours after application showing no signs of toxicity. The other animals survived the 14 day observation period. At the end of the observation period there were no changes found in necropsy in all animals. Due to this findings the oral LD50 value is > 15000 mg/kg bw.

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008 .