Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Remarks:
secondary literature; collection of data; human tox data

Data source

Reference
Reference Type:
review article or handbook
Title:
Monographs on Fragrance raw Materials. Benzonitrile
Author:
Opdyke, D. L. J.
Year:
1979
Bibliographic source:
Food. Cosmet. Toxicol. 17 Suppl.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
maximization test according to Kligman, 1966; Kligman&Epstein, 1975
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid

Method

Type of population:
not specified
Controls:
no details reported
Route of administration:
dermal

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: all (35 of 35 and 27 out of 27)
- Number of subjects with equivocal reactions: none
- Number of subjects with irritating reactions: none

RESULT OF CASE REPORT: no sensitisation reactions

Any other information on results incl. tables

The material was tested at a concentration of 2% in petrolatum and produced no sensitisation reactions (Epstein, 1977). The material was retested (same concentration) in mixed panel it produced no sensitisation reactions (Epstein, 1977).

Applicant's summary and conclusion

Conclusions:
Benzonitrile was tested at a concentration of 2% in petrolatum and produced no sensitisation reactions (Epstein, 1977). The material was retested (same concentration) in mixed panel it produced no sensitisation reactions (Epstein, 1977).
Executive summary:

Benzonitrile was tested at a concentration of 2% in petrolatum and produced no sensitisation reactions (Epstein, 1977). The material was retested (same concentration) in mixed panel it produced no sensitisation reactions (Epstein, 1977).