Registration Dossier
Registration Dossier
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EC number: 605-150-6 | CAS number: 15848-49-4
Endpoint summary
Administrative data
Description of key information
Skin irritation: irritating (OECD 439, GLP)
Eye irritation: not corrosive/not severe irritant to the eye (OECD 437; GLP compliant)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
Two reliable in vitro skin irritation studies described in Heppenheimer (2011) and Heppenheimer (2012) (OECD 439, GLP compliant) are considered to be reliable without restirctions. The substance was determined to be irritating to the skin in both studies.
Eye irritation
One reliable in vitro study described by Heppenheimer (2012) (OECD 437; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not corrosive or severly irritating to the eyes.
Justification for selection of skin irritation / corrosion endpoint:
Two in vitro skin irritation studies described in Heppenheimer (2011) and Heppenheimer (2012) (OECD 439; GLP compliant) are considered to be reliable without restrictions. Both studies showed the test substance to be irritating to the skin.
Justification for selection of eye irritation endpoint:
One reliable in vitro study described by Heppenheimer (2012) (OECD 437; GLP compliant) is considered to be reliable without restrictions. The substance was determined to be not corrosive or severly irritating to the eyes.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Skin irritation
References Heppenheimer (2011) and Heppenheimer (2012) will be used for classification. The mean relative absorbance (% of the negative control, correlating with mean tissue viability) after 15 minutes incubation in the in vitro human skin model test (EpiSkin, according to OECD 439) were as follows for the two references:
Heppenheimer (2011): relative viability = 10.9%
Heppenheimer (2012): relative viability = 49.5% (experiment 1) and 5.7% (experiment 2) (due to a borderline result in experiment 1, a second, confirming experiment was carried out).
The classification criteria according to regulation (EC) 1272/2008 as skin irritant are met, since the mean tissue viability was below the threshold for skin irritants of 50.0%.
Eye irritation
Reference Heppenheimer (2012) is considered as the key study for eye irritation and will be used for classification. According to Heppenheimer (2012), the mean in vitro score of the in vitro bovine corneal opacity and permeability assay (BCOP, according to OECD 437) was 2.6. The value was below the threshold value of 55.1 for severe eye irritants . The classification criteria according to(EC) 1272/2008 and subsequent amendments as severe eye irritant are not met, hence no classifcation is required.
Respiratory irritation
The classification as respiratory irritant is normally covered under the endpoint specific target organ toxicity- single exposure and repeated exposure.Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) for further information.
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