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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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.
Justification for type of information:
Hydrocarbons, C9-C10, aromatics, >1% Naphthalene are a combination of Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics. Read across data is available for Hydrocarbons, C9 Aromatics and Hydrocarbons, C10-C12 Aromatics and the worst case scenario for each end point has been presented.
Reason / purpose:
read-across source
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Remarks on result:
other: (~6984) mg/kg/bw)
Key result
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.
Interpretation of results:
other: Not classified
Remarks:
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.
Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C9, aromatics based on analogue read across.

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/Lg 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/Lg (6984 mg/Kg bw).

According to EU GHS guidelines, the test substance is not classified as being toxic.

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
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Remarks on result:
other: (~6984) mg/kg/bw)
Key result
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:
other: Not classified
Remarks:
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.
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/Lg 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/Lg (6984 mg/Kg bw).

According to EU GHS guidelines, the test substance is not classified as being toxic.