Registration Dossier
Registration Dossier
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EC number: 215-403-9 | CAS number: 1325-65-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40290.
Endpoint summary
Administrative data
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)
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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