Registration Dossier
Registration Dossier
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EC number: 944-884-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
non skin irritant
non eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The potential of the substance to evoke skin irritation was evaluated in-vitro in a reconstructed human epidermis (RhE) test method according to the OECD Guideline 439 and EU Method B.46. Three tissues of the human skin model EpiDermTM were treated with the substance for 60 minutes. The test item was applied directly to each tissue. DPBS-buffer was used as negative control and 5 % SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.2. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 4.1 % (required: ≤ 20 %). The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was increased to 123.5 %. This value is above the threshold for skin irritation potential (50 %). Therefore, the substance is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
Eye irritation
The eye hazard potential of the test material was evaluated according to the OECD 492 in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study. The test item was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution. Demineralised water was used as negative control and methyl acetate was used as positive control. As the test item showed intense coloring in the pre-test, there was the risk to influence the photometric measurement. Therefore, an additional test for intensely coloured test items was performed. The result of the additional test showed, that the test item colour did not influence the result of the study. The acceptability criteria were respected and the test is considered as valid.
After treatment with the test item, the mean value of relative tissue viability was 98.8 %.
This value is well above the threshold for eye irritation potential (≤ 60 %). Under the conditions of the test, the substance is considered non- eye irritant in the EpiOcularTM Eye Irritation Test.
Justification for classification or non-classification
The substance was assessed for its skin and eye irritation potential in two in-vitro studies.
Skin irritation
In the OECD 439 assay, the mean viability of the tissues after the exposure to the substance is 123.5 %. The viability is greater than 50 % and thus the substance is not considered as a skin irritant.
According to CLP Regulation guidance, the classification criteria for the in-vitro skin corrosion/irritation studies are mentioned in the corresponding OECD test guideline. Based on the results of the in-vitro study and the reccomendations of the OECD Guideline 439, the substance should not be classified for skin irritation. The substance is not classified for skin irritation according to the CLP Regulation (EC) No. 1272/2008.
Eye irritation
In the OECD 492 assay, the mean tissue viability after the exposure to the substance is found as 98.8 %. The viability is greater than 60 % and thus the substance is not considered as an eye irritant. The substance is not classified for eye irritation according to the CLP Regulation (EC) No. 1272/2008.
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