Registration Dossier
Registration Dossier
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EC number: 277-155-8 | CAS number: 72968-81-1
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)
- Additional information:
The aim of this study was to evaluate the skin sensitization potential of test item following dermal exposure in the Local Lymph Node Assay on Similar substance 01.
No mortality was observed during the main test. No significant, treatment related effect on body weights or any other sign of systemic toxicity were observed in any treatment group. No signs of irritation (monitored by erythema scoring) or any other local effect were observed at the treatment site (ears) in any treatment group.
No significant lymphoproliferation (SI ≥ 3) compared to the relevant control (DMF) was observed for the test item at the tested concentrations. The corresponding stimulation index values were 0.5, 0.9, 0.9 and 2.1 at test item concentrations of 25 %, 10 %, 5 % and 2.5 % (w/v), respectively. No significant, biologically relevant dose-response relationship was observed (p = 0.26, r = 0.74; evaluated by linear regression using the calculated SI values).
The lack of a significantly increased lymphoproliferation up to the maximum attainable concentration of 25 % (w/v, based on solubility) and also the lack of a significant, biologically relevant dose-response relationship are considered evidence that the substance is not a skin sensitizer.
Under the conditions of the assay, substance tested at the maximum feasible concentration of 25 % (w/v, based on solubility) and also at concentrations of 10 %, 5 % or 2.5 % (w/v) as formulations (apparently solutions) in a suitable vehicle (DMF) was shown to have no skin sensitization potential in the Local Lymph Node Assay.
Similar substance 01 is not a skin sensitizer.
Based on the read-across principle, the results can be considered for the assessment of the registered substance.
Justification for read-across is detailed in the report attached to the IUCLID section 13.
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.
The LLNA assay failed to calculate an EC value higher than 2 %; Stimulation Index resulted to be lower than 3 for all of the tested concentrations.
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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