Registration Dossier
Registration Dossier
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EC number: 272-062-9 | CAS number: 68683-16-9
Endpoint summary
Administrative data
Description of key information
Not eye irritant
Not skin 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)
Additional information
Eye Irritation/Corrosion
The eye irritation potential of the test substance has been investigated according to the OECD guideline 492.
The test itemwas applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 28 minutes.
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.
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. But the result of the additional test showed, that the test item colour did not critically influence the result of the study.
Demineralised water was used as negative control and methyl acetate was used as positive control.
The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD>0.8 and < 2.5, OD was 1.9. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 34.7% (< 50%).
Variation within tissue replicates of the controls and the test item was acceptable (< 20%).
After treatment with the test item, the mean value of relative tissue viability was 104.0%.
This value is well above the threshold for eye irritation potential (≤ 60%). Test items that induce values above the threshold are considered non-eye irritant.
Skin Irritation/Corrosion
The test substance has been first test for its potential to cause eye irritation according to the method above described. Due to the results obtained in the study conducted following OECD guideline 492, no further studies on skin irritation/corrosion have been taken into account and the substance is considered as non skin irritant.
Justification for classification or non-classification
According to the criteria set up on the OECD Guideline 492 the test substance is not classified as eye irritant.
No studies have been carried out to assess the skin irritation however, cosidering the results obtained in the eye irritation in vitro study, the substance has not been classified as skin irritant.
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