Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
2 male and 2 female rats dosed with 1, 2, 4, or 8 ml/kg of test substance via oral gavage.
GLP compliance:
no
Remarks:
prior to GLP
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 weeks
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Doses:
1, 2, 4, 8 ml/kg
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: daily
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Remarks on result:
other: (~6984) mg/kg/bw)
Sex:
female
Dose descriptor:
LD50
Effect level:
4 mL/kg bw
Remarks on result:
other: (~3492 mg/kg/bw)
Mortality:
One female at the 4 ml/kg dosage died on day 7 of the study. The two females given dosages of 8 ml/kg died on day 7 of the study. No males at any dosage level died during the study.
Clinical signs:
One female from the 8 ml/kg dosage group became ataxic on day 4, a condition that persisted until the death of the animal on day 7.
Body weight:
The two males receiving the 4 ml/kg dosage were underweight for 14 days.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 for female rats was 4 ml/kg bw. The LD50 for male rats was > 8 ml/kg (6984 mg/kg/bw). Given the relative density of 0.873 g/ml for the test substance, the LD50 for female rats is equivalent to 3492 mg/kg bw, at which level the test substance is considered not classifiable. m
Executive summary:

This study was conducted to determine the acute oral toxicity of Hydrocarbons, C9, aromatics to rats. 2 male and 2 female rats dosed with 1, 2, 4, or 8 ml/kg of test substance via oral gavage. One female rat in the 4 ml/kg exposure group died, and both females in the 8 ml/kg exposure group died after showing signs of lethargy and ataxia. None of the male rats in the study died. The LD50 for female rats is then 4 ml/kg. The LD50 for male rats is > 8 ml/kg (6984 mg/kg bw). According to EU GHS guidelines, the test substance is not classified as being toxic.