Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: short abstract

Data source

Reference
Reference Type:
publication
Title:
Acute toxicologic evaluation of aldadiene
Author:
McLain DE et al.
Year:
1990
Bibliographic source:
J. American College Toxicology, Part B. Vol. 1, pp. 36-37, 1990

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: according to the method of Magnusson and Kligman (1969)
Vehicle:
other: propylene glycol (1st induction), petrolatum (2nd induction, glycerine (challenge)
Concentration / amount:
1st induction (day 0): 5 % ;
2nd induction (day 7): 10 % ;
challenge (day 21): 2.5 %
Challengeopen allclose all
Route:
other: according to the method of Magnusson and Kligman (1969)
Vehicle:
other: propylene glycol (1st induction), petrolatum (2nd induction, glycerine (challenge)
Concentration / amount:
1st induction (day 0): 5 % ;
2nd induction (day 7): 10 % ;
challenge (day 21): 2.5 %
No. of animals per dose:
30 (15 per sex)
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data

Any other information on results incl. tables

No contact sensitisation. Potential for mild irritation.

Applicant's summary and conclusion

Executive summary:

In a guinea pig maximization test (GPMT) the test substance revealed no skin sensitising potential. A potential for mild irritation was observed.