Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 402. GLP.
Justification for type of information:
See read-across justification provided in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
(note: CAS No. not assigned in original reference).

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
3750 mg/kg
No. of animals per sex per dose:
4 males and 4 females/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 750 mg/kg bw
Mortality:
One animal died on day 6 of the 14-day post-exposure observation period.
Clinical signs:
Erythema and edema were observed at the test site.
Gross pathology:
Necropsy revealed congested lungs and white areas on the liver. In addition, four animals were found to have congested lungs, but it was not clear that this effect was treatment-related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for unleaded gasoline (API PS-6) in the rabbit is >3750 mg/kg. This finding does not warrant classification of the test material as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Executive summary:

The acute toxicity of unleaded gasoline (API PS-6) was evaluated in rabbits via occlusive dermal application at 3750 mg/kg. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the following 14 days. One animal died on day 6 post-exposure. Erythema and edema were observed at the test site during the observation period. Necropsy revealed congested lungs and white areas on the liver. In addition, four animals were found to have congested lungs, but it was not clear that this effect was treatment-related. The LD50 for unleaded gasoline (API PS-6) is >3750 mg/kg.

This finding does not warrant classification of the test material as an acute dermal toxicant under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).