Registration Dossier
Registration Dossier
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EC number: 915-617-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: the substance does not cause skin irritation based on OECD TG 404.
Eye irritation: not irritant based on OECD TG 405.
The substance is not irritating to skin and eyes and is not expected to be a respiratory 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 adverse effect observed (not irritating)
Additional information
Skin irritation
Skin irritating properties of the test substance were studied in two studies with rabbits conducted in compliance with GLP (Toxicol Laboratories Limited, Key study 1985 and supporting study 1984), performed according to the protocol described in the methods for the determination of toxicity in Annex V of EEC Directive 79/831 (similar to OECD 404). The test substance, 0.5 mL undiluted, was applied for 4 hours under semi-occlusive conditions to an area of 2.5 cm2 in 4 (1985) or 3 (1984) female rabbits. After 4 hours, the test substance was removed by gentle swabbing with cotton wool soaked in warm water, and animals were observed for 168 hours. The mean erythema and oedema scores over 24, 48 and 72 hours were 1.2 and 0.2 (1985) and 1.4 and 0.3 (1984). In all cases, oedema was fully reversible within 72 hours, while slight erythema (score 1) was still observed at the end of the 7 days observation period in 2 (1985) or 1 (1984) animals. Despite the fact that the irritation was not fully reversible at the end of the study period the effects were decreasing and minor and therefore the test substance was concluded to be non-irritating to rabbit skin. The study from 1985 is selected as key study with the study from 1984 supporting the results.
Eye irritating
Eye irritating properties of the test substance were studied in a pre-GLP study with rabbits, conducted according to a protocol similar to OECD TG 405 (Cosmopolitan Safety Evaluation Inc., 1980). A single instillation of 0.1 mL undiluted test substance into the eyes of 6 rabbits resulted in mean scores of 0.3, 0.1, 1.1 and 0.3 for cornea, iris, conjunctiva and chemosis, respectively, over 24, 48 and 72 hours. All effects were fully reversible within 72 hours. Based on these results, the test substance was concluded to be non-irritating to rabbit eyes.
Respiratory irritation
For assessing respiratory irritation mostly human data are used because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3). However, there are no human data such as indicated in R7.2.3 the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. In experimental tests the test substance is not corrosive or irritating for the skin or eye, which minimizes the respiratory irritation hazard (REACH guidance: 7.2.1.2). Furthermore the test substance has a low volatility of 0.0055 Pa and will limitedly vapourise as such and from mixtures. Therefore no C&L is needed for the respiratory irritation.
Justification for classification or non-classification
Based on the negative results of the available studies, classification of the substance for skin, eye or respiratory irritation is not warranted in accordance with EU CLP (EC no 1272/2008 and its amendments).
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