Registration Dossier

Administrative data

Description of key information

A guinea pig maximisation test is available for the substance which was provided by ECHA.

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: Data migrated from NONS with permission to refer granted by ECHA.
Qualifier:
according to
Guideline:
other: 92/69/EEC (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data provided by ECHA and permission to refer granted. No justifications available for why the LLNA was not used.
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
other: 5% in water
Concentration / amount:
Induction: Intradermal 5% in water and topical 100% (unchanged).

Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Route:
other: Epicutaneous (no futher details)
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
Not specified
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 in the test group and 10 in the negative control.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation

Maximum concentration not causing irritating effects in the preliminary test: 100%

Signs of irritation during induction: irritation was observed following application of sodium lauryl sulfate and prevented scoring of irritation due to the test substance alone. In the preliminary study no irritation was observed following intradermal injection (5%) or topical application (100%).

No evidence of sensitisation at each challenge was observed.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on information provided by ECHA, no evidence of skin sensitisation was observed in a guinea pig maximisation test. In accordance with the CLP Regulation (1272/2008) no classification for skin sensitisation effects is warranted.