Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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: see 'Remark'
Remarks:
Summary study report. The response to the positive control challenge was not remarkable. It is doubtful therefore, that the assay used is sufficiently sensitive. 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 INFORMATION ON Distillate fuel oils
Author:
American Petroleum Institute
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON Distillate fuel oils pag 44-45

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
The API procedure is defined in: Any other information on materials and Methods
GLP compliance:
not specified
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml undiluted
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.5 ml undiluted
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: See: Any other information results incl. tables
Remarks on result:
other: Reading:

Any other information on results incl. tables

The average scores for erythema and edema during the induction phase and after challenge are tabulated below.

   Test material  Positive control
 Induction    
 Erythema  1.3 1.3 
 Edema 0.3  0.3 
 Challenge  
 Erythema 1.3  1.9 
 Edema 0.3  0.7 

The authors concluded that the test material was not sensitizing since the differences between induction and challenge scores were not statistically significant.

Applicant's summary and conclusion