Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
not specified
Sex:
male/female
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 %
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
Positive control results:
no data

No contact sensitisation. Potential for mild irritation.

Executive summary:

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guinea pig maximization test (GPMT) the test substance revealed no skin sensitising potential. A potential for mild irritation was observed (McLain et al., 1990).


Migrated from Short description of key information:
Guinea pig maximation test: not sensitising [McLain et al. 1990]

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.