Registration Dossier
Registration Dossier
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EC number: 944-062-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Not sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation
According to the CLP Regulation n. 1272/2008, substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) 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 (according to 3.4.2.2.4.1).
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:
Local lymph node assay-EC3 value ≤ 2 %
Guinea pig maximisation test- ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose
Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical 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.
Local lymph node assay - EC3 value > 2 %
Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose
Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.
Under the experimental conditions employed, 10% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
As conclusion, according to the paragraph 3.4 of the CLP Regulation n. 1272/2008, the registered substance is not classified as skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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