Registration Dossier
Registration Dossier
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EC number: 456-880-5 | CAS number: 439685-79-7
Endpoint summary
Administrative data
Description of key information
LD50>2000 mg/kg bw in a limit test by oral route.
LD50>2000 mg/kg bw in a limit test by dermal route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley rats were given a single oral (gavage) dose of Mexoryl SBF at 2000 mg/kg bw. No mortality was observed. Piloerection was observed within 2 h of treatment in 3/6 animals. No other clinical signs were noted. During the first week of the study, a reduced body weight gain and a body weight loss were observed in 2/6 and 1/6 animals, respectively, without any relevant consequence at the end of the study. The overall body weight gain of the other treated animals was not affected by treatment with the test item. No macroscopic abnormalities were observed at study termination on Day 15.
In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a group of Sprague Dawley rats (5/sex/dose) were given a single dermal application of Mexoryl SBF at 2000 mg/kg bw. No deaths, no clinical signs and no cutaneous reactions were observed during the study. When compared to historical control animals, a slightly lower body weight gain was noted in 1/5 females between Day 1 and Day 8 and in another female between Day 8 and Day15, without any relevant consequence at the end of the observation period. Overall body weight gain of the other animals was similar to that of historical control animals. No macroscopic abnormalities were observed at necropsy.
Justification for classification or non-classification
Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore MEXORYL SBF does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (EC) N° (1272/2008).
Based on the available data no additional self-classification is proposed regarding specific target organ toxicity - single exposure
according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC. No data were available by inhalation.
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