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EC number: 261-332-1 | CAS number: 58567-11-6
Oral (OECD 401), rat: LD50 > 5000 mg/kg body weight leading to not classification according to GLPDermal (OECD 402), rat: LD50 > 5000 mg/kg body weight leading to not classification according to GLPInhalation: no information available
Ten healthy male Wistar rats with initial body weights between 165-198 grams were treated with 5000 mg/kg bw test substance orally. The animals were fasted prior to dosing. Clinical observations for mortality and/or systemic effects were made daily up to 14 days post dosing. Isolated instances of diarrhea, chromorhinorrhea and emaciation were noted during early part of the study. All animals survived up to end of study and were sacrificed on day 14. No effects were observed at gross necropsy. The LD50 was > 5000 mg/kg bw.
Ten (2 male and 8 female) healthy New Zealand White rabbits with initial body weights of 2.2 -2.8 kilograms received one dermal application 5000 mg/kg bw test item. The test material was applied to clipped, intact or abraded abdominal skin under occluded patches for 24 hours. Afterwards the exposure site was wiped, but not washed, to remove excess material. Observations for mortality and/or systemic effects were made daily for 14 days. Dermal reactions were scored at 24 hours by the Draize scoring system and were variable ranging from slight erythema and edema to severe erythema and moderate edema. Body weights were recorded pretest and at 14 days. All animals survived until end of the study and gross necropsy was conducted. In 9/10 animals scaly treated skin was observed. The acute dermal LD50 >5 g/kg.
- oral toxicity:
The test substance is not acutely toxic to rats in a reliable and valid acute oral toxicity study and the oral LD50 value is > 5000 mg/kg body weight (1980a).
- dermal toxicity:
The substance was not acutely toxic in a reliable and valid acute dermal toxicity study in rabbits with a dermal LD50 value > 5000 mg/kg body weight (1980b).
- inhalation toxicity:
Information about the acute inhalation toxicity of the substance is not available.
Dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the registration item exhibits no acute toxicity.
Based on the above stated assessment of the acute oral toxicity of the substance, the results from a reliable study are above the threshold value given in the CLP Regulation. Therefore the substance does not need to be classified according to CLP Regulation (EC) No. 1272/2008 of the European Parliament and of the Council as implementation of UN-GHS in the EU.
Based on the above stated assessment of the acute dermal toxicity, the substance does not need to be classified according to CLP Regulation (EC) No. 1272/2008 of the European Parliament and of the Council as implementation of UN-GHS in the EU.
According to regulation (EC) 1907/2006 Annex XI (weight of evidence), testing for acute inhalation toxicity is not considered to be required, for the following reasons:
- The test substance has a negligible vapour pressure. Thus an acute 4-hour inhalation study would be carried out at the limit dose of 5 mg/L aerosol. Assuming a very conservative value of 100% bioavailability, a rat would receive a systemic dose of 0.8 L/min/kg x 240 min x 5 mg/L aerosol = 960 mg/kg.
- Since the acute oral LD50 was higher than this value, it is considered unlikely that mortality would be observed in an acute inhalation study. In the acute oral toxicity study no effects were observed at the limit dose of 5000 mg/kg.
- With regard to possible local respiratory effects, the test substance is not classified for eye irritation and showed no irritation effects on the mucosal membranes of the eyes. Upon occluded application to the skin, the test substance showed irritative effects to the skin. In conclusion, the test substance is considered unlikely to exert a relevant local irritative effect on respiratory mucosal membranes.
Therefore, performance of an acute inhalation study is considered not necessary for scientific reasons and the test substance is considered unlikely to exert effects upon inhalation that would require classification according to CLP Regulation (EC) No. 1272/2008.
The substance does not have to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No. 1272/2008, as no specific toxic effects were observed after acute exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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