Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Near-guideline, GLP-compliant study. Adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Principles of method if other than guideline:
The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Viscous hydrocarbon liquid
Details on test material:
Catalytic cracked clarified oil (CCCO), API 81-15, CAS No. 64741-62-4.
Dark brown viscous liquid

Data below taken from American Petroleum Institute (1985d). In-vivo sister chromatid exchange (SCE) assay. Catalytic cracked clarified oil, API Sample 81-15, CAS No. 64741-62-4. Testing laboratory: Microbiological Associates Inc., 5221 River Road, Bethesda, MD 20816, USA. Owner company: American Petroleum Institute, 2101 L Street, Northwest, Washington, DC 20037, USA. Study number: 32-32754. Report date: 1985-11-25.

Gravity API: 0.1
Specific gravity: 1.0753
Viscosity in SUS @ 210 °F: 56.1
Flash Point °F: 396
Sulfur wt %: 1.1
Pour Pt °F: 35
Asphaltenes % (MN 596): 4.2
Carbon residue wt %: 4.6
Ash wt %: 0.05

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Body weight at study initiation: approx.2.6 kg

IN-LIFE DATES: From: 15 January 1982 To: 29 January 1982.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Fur was clipped from a region of skin (equivalent to around 10% of the total body area) approx. 18 hr prior to dosing. The test site from 2 males and 2 females was lightly abraded immiediately before treatment.
Duration of exposure:
24 hr
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 male / 2 female - intact skin
2 male / 2 female - abraded skin
Control animals:
not required
Details on study design:
The test substance was administered dermally to male and female rabbit and animals observed for 14 days. Body weights were recorded the prior to treatment and again at gross necropsy on day 14.
Statistics:
None used

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No
Clinical signs:
No
Body weight:
Weight gain unremarkable
Gross pathology:
No abnormalities detected
Other findings:
None

Any other information on results incl. tables

No deaths resulted and there were no significant clinical signs. Any erythema that may have been present after patch removal was obscured by the black tarry test substance.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 > 2000 mg/kg bw
Executive summary:

The test substance was administered to clipped skin from groups of male and female NW rabbits (n = 4/sex) at 2000 mg/kg bw followed by a 14 day observation period.

The test site from 2 animals per sex was lightly abraded prior to dosing. There were no clinical signs or evidence of systemic toxicity, and all animals gained weight during the post-treatment period. No lesions were present at scheduled necropsy. 

The acute dermal LD50 was >2000 mg/kg bw in both sexes.