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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:
weight of evidence
Study period:
Apr 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study design similar to OECD 401 with deviations and restricted reporting

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7 days recovery, females tested
GLP compliance:
no
Remarks:
performed before GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 99.6 g (mean)
- Fasting period before study: 12 h
- Diet (e.g. ad libitum): Standard Altorim R (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%
Doses:
1.0; 1.6; 2.5; 4.0 or 6.3 mL/100 g bw
according to
1055; 1688; 2638; 4200 or 6647 mg/kg bw ((assuming a density of 1.055 g/cm3 in case of a 10% solution)
No. of animals per sex per dose:
10 females/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
Statistics:
LD50 derivation according Kärber method

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2.55 other: (10% solution)/100 g bw
Remarks on result:
other: corresponding to 2690 mg/kg bw/d
Mortality:
Dose: 1055 mg/kg bw; Mortality rate: 0/10
Dose: 1688 mg/kg bw, Mortality rate: 3 / 10
Dose: 2638 mg/kg bw, Mortality rate: 4 / 10
Dose: 4220 mg/kg bw, Mortality rate: 10 / 10
Dose: 6647 mg/kg bw, Mortality rate: 10 / 10
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of the testsubstance was 2690 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

The test item was tested for its acute oral toxicity potential. 10 female rats were treated with doses of 1055, 1688, 2638, 4220 or 6647 mg/kg bw and observed for 7 days.

The median lethal dose was 2690 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements according to regulatory requirements.