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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to GLP and internationally recognized test guidelines (OECD).
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Route:
intradermal
Vehicle:
polyethylene glycol
Concentration / amount:
0.2%
Route:
epicutaneous, open
Vehicle:
polyethylene glycol
Concentration / amount:
0.2%
No. of animals per dose:
10 at 0.2%, 5 at 0% (control)
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
0.2%
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 0.2%. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2%. No with. + reactions: 5.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin reactions observed in response to a 50% test substance concentration in five of ten experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 50 per cent.
Executive summary:

Substance is classified as Skin Sensitiser, category 1B according EU CLP as it meets the criteria for guinea pig maximisation test requiring ≥ 30 % to <60% responding at >0.1% to <= 1% intradermal induction dose.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:
Migrated from Short description of key information:
The skin reactions observed in response to a 50% test substance concentration in five of ten experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 50 per cent.

Justification for selection of skin sensitisation endpoint:
Selected as best available data.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification