Registration Dossier
Registration Dossier
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EC number: 931-291-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Reliable in vivo studies demonstrate that the substance is not irritant and not corrosive to the skin. Based on all the available data, the substance should be considered as a substance causing serious eye damage (Category 1; irreversible effects on the eye).
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:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion: Three studies in rabbits (reliability: 1) and Human volunteer studies (reliability: 4); Eye irritation: Six studies in rabbits (reliability 1 and 2). See the section justification for classification or non-classification for further information.
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin irritation:
Generally, primary emphasis shall be placed upon existing human experience and data, followed by animal experience and testing data, followed by other sources of information. The three studies in rabbits showed irritation, but the mean value of the scores for either erythema/eschar or oedema calculated was below the criteria for classification in all animals. In addition, the effects reversed during the observation period. On the other hand, the available human data showed responses of mild to moderate erythema. But the results of the human volunteer studies can not be interpreted in relation to classification as the conduct of the study does not allow this. They are cumulative occluded applications, mostly for 4 consecutive 24-hour applications, and up to 14 days. Moreover, as comparable results were obtained with the negative control (deionized water), it can not be established whether the reported effects were substance related effects. The results from the human studies are therefore interpreted as inconclusive. Based on the 3 studies in rabbits, the substance is not classified.
Eye irritation:
All the conducted studies in rabbits showed irritation to eyes, resulting in classification based on the mean scores following grading at 24, 48 and 72 hours after installation of the test material. Moreover, in 2 of the studies (reported under section 5.4.1), the effects in one animal on the cornea and conjunctiva did not fully reverse within the observation period of 21 days. Therefore, based on all the available data, the substance should be considered as a substance causing serious eye damage (Category 1; irreversible effects on the eye).
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