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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: RELIABLE SUMMARY REPORT
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
ROBUST SUMMARY OF INFORMATION ON HEAVY FUEL OILS
Author:
AMERICAN PETROLEUM INSTITUTE
Year:
2003
Bibliographic source:
ROBUST SUMMARY OF INFORMATION ON HEAVY FUEL OILS PG 50

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: BUEHLER TEST
Deviations:
not specified
Principles of method if other than guideline:
METHOD BUEHLER TEST
GLP compliance:
not specified
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Concentration / amount:
0.5 ml diluted (1:2 in mineral oil) test material w as applied under occlusion to the shorn skin of 10 guinea pigs.
Challengeopen allclose all
Route:
other: MINERAL OIL
Concentration / amount:
0.5 ml diluted (1:2 in mineral oil) test material w as applied under occlusion to the shorn skin of 10 guinea pigs.
No. of animals per dose:
10

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: SEE NY OTHER INFORMATION ON RESULTS INCL. TABLES
Remarks on result:
other: Reading:

Any other information on results incl. tables

The following responses were recorded.

Group                                          Incidence              Severity

HVGO test group                            1/10                     0.1&0.0

HVGO challenge control                   0/4                      0.3&0.0  

Positive control                                10/10        3.6&3.3

DNCB challenge control               0/4                      1.0&0.0

These data demonstrate that the test material is not a skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information