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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Standard method equivalent to EC method, GLP-compliant, adequate experimental details for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 h
Doses:
single dose - 2000 mg/kg bwt
No. of animals per sex per dose:
2 female - 2000 mg/kg bwt
2 male - 2000 mg/kg bwt
Details on study design:
gp1 = 1 male, 1 female - intact skin prior to treatment
gp2 = 1 male, 1 female - skin abraded prior to treatment

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 2; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No signs of systemic reaction.
Other findings:
Signs of toxicity (local):
Slight to moderate local irritation noted.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study on the analogous substance, Renewable Diesel is predicted to be of low toxicity via dermal route of exposure.