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Toxicological information

Acute Toxicity: dermal

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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:
1970
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

Constituent 1
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

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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