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Diss Factsheets

Administrative data

Description of key information

The skin reactions observed in response to a 100% test substance concentration in six (of the 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 60 per cent.

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: ECHA provided robust study summary
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation test).
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The Guinea Pig Test met the previous requirements before the entry into force of REACH. The test is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
Species:
guinea pig
Strain:
other: Himalayan strain, albino guinea pig
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
5% concentration
Day(s)/duration:
8
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
2
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Maximum concentration not causing irritating effects in preliminary test: 100 %
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
Yellow staining in all animals was observed. This staining did not hamper the scoring of the skin reactions.
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
Yellow staining in one animal was observed. This staining did not hamper the scoring of the skin reactions.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Yellow staining in one animal was observed. This staining did not hamper the scoring of the skin reactions.
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
5

Signs of irritation during induction: Mild to moderate erythema was seen in all animals.

Evidence of sensitisation of each challenge concentration: Number of animals showing evidence of sensitisation at each

challenge concentration: Six

Other observations: Bodyweight gains of animals in the test group, between Day 0 and Day 24, were comparable to those in the control group. Yellow staining was observed at the test substance treated skin sites, 24 and/or 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The skin reactions observed in response to a 100% test substance concentration in six (of the 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 60 per cent.
Executive summary:

The study to assess the Contact Hypersensitivity to the test item in the Albino Guinea Pig (Maximisation Test) was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation". Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermal injected with a 5% concentration and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). In the challenge phase, skin reactions of grade 1 were observed in six experimental animals in response to the 100% test substance concentration. No skin reactions were evident in the control animals. Yellow staining was observed at the test substance treated skin sites, 24 and/or 48 hours after challenge. This staining did not hamper the scoring of the skin reactions. The skin reactions observed in response to a 100% test substance concentration in six (of the 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 60 per cent.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The study to assess the Contact Hypersensitivity to the test item in the Albino Guinea Pig (Maximisation Test) was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation". Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermal injected with a 5% concentration and epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil). In the challenge phase, skin reactions of grade 1 were observed in six experimental animals in response to the 100% test substance concentration. No skin reactions were evident in the control animals. Yellow staining was observed at the test substance treated skin sites, 24 and/or 48 hours after challenge. This staining did not hamper the scoring of the skin reactions. The skin reactions observed in response to a 100% test substance concentration in six (of the 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 60 per cent.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is classified and labelled as skin sensitising Cat 1B (H 317) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.