Registration Dossier
Registration Dossier
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EC number: 200-906-8 | CAS number: 75-83-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it is an acceptable well-documented publication which meets basic scientific principles.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg - Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: saran wrap sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with damp towels
- Time after start of exposure: 4 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg - Duration of exposure:
- 4 hrs
- Doses:
- up to 5.0 ml/kg
- No. of animals per sex per dose:
- 3 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Statistics:
- method of Litchfield and Wilcoxen
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Remarks on result:
- other: 3.35 g/kg
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Animals showed signs of discomfort and were uncoordinated at the end of the exposure period.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 4-hr LD50 for dermal exposure in rabbits is > 5.0 mL/Kg bw (3.35 g/Kg).
- Executive summary:
This study examined the dermal toxicity of the hexane. Doses of up to 5.0 mL/Kg of test substance was placed on the shaved skin of 3 male rabbits. The test area was then covered with a saran wrap sleeve for 4 hrs. After the exposure period, the test substance washed off, and the animals observed for toxicity and mortality over the next 14 days.
No animals died, however, they did show signs of discomfort and uncoordination after the exposure. The LD50 for dermal exposure is >5.0 mL/Kg (3.35 g/Kg). The test substance is not classified as toxic under EU GHS guidelines.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Toxicological Properties of Hydrocarbon Solvents
- Author:
- Hine, CH, and Zuidema, HH
- Year:
- 1 970
- Bibliographic source:
- Industrial Medicine, Vol. 39, No. 5, May 1970.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
- IUPAC Name:
- C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
- Details on test material:
- - Name of test material (as cited in study report): S-1
- Composition of test material, percentage of components: C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2-3 kg
Administration / exposure
- Type of coverage:
- occlusive
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: saran wrap sleeve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with damp towels
- Time after start of exposure: 4 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg - Duration of exposure:
- 4 hrs
- Doses:
- up to 5.0 ml/kg
- No. of animals per sex per dose:
- 3 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs - Statistics:
- method of Litchfield and Wilcoxen
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Remarks on result:
- other: 3.35 g/kg
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Animals showed signs of discomfort and were uncoordinated at the end of the exposure period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 4-hr LD50 for dermal exposure in rabbits is > 5.0 mL/Kg bw (3.35 g/Kg).
- Executive summary:
This study examined the dermal toxicity of the hexane. Doses of up to 5.0 mL/Kg of test substance was placed on the shaved skin of 3 male rabbits. The test area was then covered with a saran wrap sleeve for 4 hrs. After the exposure period, the test substance washed off, and the animals observed for toxicity and mortality over the next 14 days.
No animals died, however, they did show signs of discomfort and uncoordination after the exposure. The LD50 for dermal exposure is >5.0 mL/Kg (3.35 g/Kg). The test substance is not classified as toxic under EU GHS guidelines.
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