Aromatic hydrocarbons, C9-12, benzene distn.

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Aromatic hydrocarbons, C9-12, benzene distn.

EC Number:

295-551-9

EC Name:

Aromatic hydrocarbons, C9-12, benzene distn.

Cas Number:

92062-36-7

Molecular formula:

not applicable for UVCB substances

IUPAC Name:

Aromatic hydrocarbons, C9-12, benzene distn.

Test animals

Species:

rat

Strain:

other: Charles River CD

Sex:

male/female

Details on test animals or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 8 mL/kg bw

Remarks on result:

other: (~6984) mg/kg/bw)

Effect levels 2

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:

other: 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.

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.