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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Summary study report

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON LUBRICATING OIL BASESTOCKS pag 30-31

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
The test procedure was consistent with that given in OECD Guideline 404 (1981) except that the exposure period was 24 hours rather than the 4 hours recommended in the OECD protocol.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
other: see any other information on materials and methods
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
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
Time point:
other: Results of the 24 and 72-hour readings were used to determine the Primary Irritation Index.
Score:
ca. 5.4
Max. score:
5.8
Reversibility:
no data

Any other information on results incl. tables

 Observation period  Erythema Intact Erythema Abraded  Edema Intact Edema Abraded  Average Score
 24 hrs.  2.3  2.3 2.7  2.7 
 72 hrs.  3.0 3.0  2.5  3.0  5.8 
 96 hrs.  2.7 2.8  2.7  3.0  5.6 
 7 days  1.3 2.2  0.8  1.7  3.0 
 14 days

Primary dermal irritation index: 5.4

Applicant's summary and conclusion