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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
from July to August
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright White
Sex:
male/female
Route:
intradermal
Vehicle:
other: liquid paraffin
Concentration / amount:
Induction: 2.5 w/v%
challenge: 15 w/v%
Route:
epicutaneous, occlusive
Vehicle:
other: liquid paraffin
Concentration / amount:
Induction: 2.5 w/v%
challenge: 15 w/v%
No. of animals per dose:
control group: 10 (5/sex)
test substance group: 10 (5/sex)
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
challenge 15 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
challenge 15 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.

The intradermal injections (induction procedere) did not produce necrosis and ulcerations at the application site.

Executive summary:

In a guinea pig maximization test (GPMT) according to OECD TG 406 the test substance proved to be not senistizing after challenge with 15 % test substance.

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

In a guinea pig maximization test (GPMT) according to OECD TG 406 no skin sensitizing potential of the test substance could be observed based on the results after challenge with 15 % test substance.


Migrated from Short description of key information:
Guinea pig maximation test: not sensitising [Müller, 1987]

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 required.