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Description of key information

Not skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

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

No study on target substance was available, thus a read across approach was followed for the assessment. In particular, studies on Similar Substance 01 and Similar substance 02 according to OECD guideline 406 were used. Details on the read across are available in section 13.

In a study from 1995 on Similar Substance 01, a sample with high purity (90 % dye, described as "purified") was tested. After intradermal induction at 5 %, no skin reactions were seen in 20 female guinea pigs.

In a study from 1994 on Similar Substance 01, a sample with 80 % purity, described as "raw", was tested. After intradermal induction at 5 %, a positive response was seen in 15 % and 30 % of treated animals after 24 h and 48 h, respectively. In particular, skin reactions were noted in 2/10 male and 4/10 female animals, 48 h after removal of the dressing.

As no positive response was seen in the study from 1995, despite

- the content of test substance was higher than in the study from 1994,

- only female animals were used, which were found to be more sensitive than males in the study from 1994,

the sensitisation response in the study from 1994 was reasonably attributed to the impurities content of test sample. Therefore, such study was disregarded, while the study from 1995 was selected as key study.

The lack of skin sensitising potential was confirmed by results of a study on Similar Substance 02. The evaluation for skin reactions, 24 h after challenge, showed 10 % positive responses in guinea pigs. No positive responses were noted 48 h after challenge.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Category 1

Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test.

As for guinea pig maximisation test, a response of at least 30 % of animals is considered positive.

Subcategorisation is done as follows in case of a guinea pig maximisation test:

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria: ≥ 30 % responding at ≤ 0.1 % intradermal induction dose or ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Specific criteria: ≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % topical induction dose.

As no positive response was seen in test animals upon a 5 % intradermal induction dose, the substance is not classified within the CLP Regulation (EC 1272/2008).

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