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Administrative data

Description of key information

Skin sensitising

Key value for chemical safety assessment

Skin sensitisation

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

No information on "skin sensitisation" is available for the Target Substance. However data on a Similar Substance (Similar Substance 02) was taken into account for the assessment. More information about the similarity between the two substances is reported in section 13. The substance has been tested for its skin sensitisation potential according to the OECD guideline 406.

In this study 40 % of the animals were positive at the 24-hour reading and 25 % at the 48-hour reading after treatment with a non-irritant test substance concentration of 25 % in vaselinum album.

The response of at least 30 % positive animals following an intradermal induction of 5 % is considered as positive.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

SKIN SENSITIZATION

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.

Specific criteria of animal test:

when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive.

For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.

Furthermore, stimulation index of three or more is considered a positive response in the local lymph node assay.

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:

Guinea pig maximisation test-≥ 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.

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.

Based on the result obtained in the Guinea Pig Maximisation Test, according to the paragraph 3.4. of the CLP Regulation EC n. 1272/2008, the test substance is classified in Sub Category 1B,  as more than 35 % of animals were positive after treatment with a non-irritant test substance concentration of 25 % in vaselinum album (intradermal induction dose = 5 % of test substance).