Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary report. Although the study was conducted before Good Laboratory Practices were published, the study appears to have been conducted using appropriate methods and to have been fully reported.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF NFORMATION ON Distillate Fuels
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF NFORMATION ON Distillate Fuels 42-43

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
The method is draize Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
ca. 6.81
Remarks on result:
other: See table information

Any other information on results incl. tables

At 24 hours the skin of all rabbits was very irritated. Blisters had formed and some of these had opened.

At 72 hours the sites were still very irritated and open sores were observed in 2 rabbits.

At day 7 scabs had formed at most test sites

At day 14 the skin was healing but was still dry and flaky and there had been no hair growth.

Average scores for erythema and edema are listed below

Exposure time (h) Average score
Erythema     
Intact skin  24 4.0
72 3.83
Abraded skin  24 4.0
72 3.83
Edema     
Intact skin  24 3.0
72 2.92
Abraded skin  24 3.0
72 2.67

Applicant's summary and conclusion