Registration Dossier

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No data on test method. No GLP.

Data source

Reference
Reference Type:
review article or handbook
Title:
Fragrance raw materials monographs - Camphen
Author:
Opdyke DLJ
Year:
1975
Bibliographic source:
Food. Cosmet. Toxicol. (1975) 13, 735-738

Materials and methods

Principles of method if other than guideline:
A maximization test (Kligman, 1966; Kligman & Epstein, 1975) was carried out on 25 volunteers.
No more data was provided on the method.
GLP compliance:
no
Type of study:
other: maximization test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Camphene

In vivo test system

Test animals

Species:
human
Strain:
other: Not applicable
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
The material was tested at a concentration of 4 % in petrolatum.
Challengeopen allclose all
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
The material was tested at a concentration of 4 % in petrolatum.
No. of animals per dose:
25 human subjects
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: No data
Group:
test group
Dose level:
4 %
No. with + reactions:
0
Total no. in group:
25
Remarks on result:
other: Reading: other: No data. Group: test group. Dose level: 4 %. No with. + reactions: 0.0. Total no. in groups: 25.0.

Any other information on results incl. tables

The material was tested at a concentration of 4 % in petrolatum and produced no sensitization reactions.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The material was tested on humans at a concentration of 4 % in petrolatum and produced no sensitization reactions.
Executive summary:

A maximization test was carried out on 25 volunteers. The material was tested at a concentration of 4 % in petrolatum and produced no sensitization reactions.