Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.