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Description of key information

No study on skin sensitisation is available with the target substance. Data generated with the category substances LABS and LABS Na were considered to be pivotal datasets to assess this endpoint. The target substance is considered not sensitising to skin and therefore not to be classified.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
The justification document on the read across category approach is included in IUCLID section 13.
Justification for non-LLNA method:
The guinea pig maximization test was performed prior to publication of the OECD guideline 429.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Group:
negative control
Remarks on result:
other: Data not available
Reading:
2nd reading
Group:
negative control
Remarks on result:
other: Data not available
Reading:
1st reading
Group:
positive control
Remarks on result:
other: Data not available
Reading:
2nd reading
Group:
positive control
Remarks on result:
other: Data not available
Interpretation of results:
GHS criteria not met
Conclusions:
There is no skin sensitisation study available with the target substance. Data generated with LABS is considered pivotal to this endpoint. The target substance is considered to be non sensitising and therefore not to be classified according to CLP Regulation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No skin sensitisation study is available with the target substance. The data generated with the category substances LABS and LABS Na are considered pivotal datasets within the category to assess this endpoint.

A group of 10 male and 10 female guinea pigs were used to determine the potential of LABS to be sensitising to skin according to test protocol from Magnusson, B., and Kligman, A.M. (1969) study. The animals were first given an intradermal induction of 0.05% of test substance in corn oil. One week later, they were given a dermal induction of 5% test substance in corn oil. A group of 5 male and 5 female guinea pigs were used as controls. These animals were treated in a similar fashion with vehicle only. Two weeks after the dermal induction, a challenge was performed via dermal exposure to 2.5% test substance in corn oil. The control group was exposed as well. The animals were exposed for 24 hrs. Skin irritation readings were made at 24 and 48 hrs after the end of exposure. No positive responses were seen in either the test or control group. The test substance is not sensitising to skin.

A guinea pig maximization test was performed with LABS Na to determine the skin sensitisation potential. Ten male and ten female guinea pigs were given intradermal injections of 25% test solution. Control animals (5 male and 5 female) were given injections of vehicle only. One week later, a second induction was done by dermal exposure to 25% test solution for 24 hrs. Control animals were again exposed to vehicle only. On day 21, the challenge exposure was performed. All animals were exposed to 12.5% test solution dermally. Exposure was for 24 hrs, with observations made at 48 and 72 hrs after the start if exposure. No positive reactions were noted. The test substance is not sensitizing.

The target substance is considered to be non sensitising to skin and therefore not to be classified according to CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance is considered to be non sensitising and therefore not to be classified according to CLP Regulation.