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Diss Factsheets

Administrative data

Description of key information

Key study: EU Method B.6 (GLP study). The substance was determined to be not a skin sensitiser in guinea pig.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Species:
guinea pig
Strain:
other: Himalayan
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
Intradermal: 20%
Epicutaneous: 100%
Adequacy of induction:
not specified
No.:
#1
Route:
other: Epicutaneous
Vehicle:
not specified
Concentration / amount:
100%
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Concentration of test material and vehicle used at induction:
Based on the results of the preliminary study a 20% concentration for the intradermal induction and the undiluted test substance for the epidermal induction was used.

Concentration of test material and vehicle used for each challenge:
The undiluted test substance was used for the challenge phase.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5

Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction:
The intradermal injections showed some erythema in controls as well as in test animals. Some animals showed also signs of necrosis. The epidermal exposure revealed in two animals in eschar formation.


Other observations:
No skin reactions were evident after challenge exposure in the experimental and control animals.


No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.


Body weights and body weight gain of experimetnal animals remained in the same range as controls over the study period.

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not a skin sensitizant in the GPMT.
Executive summary:

A skin sensitization study was conducted according to EU Method B.6 (GLP study). A total of 15 Himalayan guinea pig were treated at a single dose divided in two groups (10 test substance and 5 negative control). Based on the results of the preliminary study a 20% concentration for the intradermal induction and the undiluted test substance for the epidermal induction was used. The undiluted test substance was used for the challenge phase. No skin reactions were evident after challenge exposure in the experimental and control animals. Thus, the substance was determined not to be an skin sensitizer.

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

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for sensitisation according to the CLP Regulation (EC) no. 1272/2008.