Registration Dossier
Registration Dossier
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EC number: 210-498-3 | CAS number: 616-91-1
Endpoint summary
Administrative data
Description of key information
According to the available literature, the oral LD50 of the test substance is above 3000 mg/kg bw in mouse and above 5050 mg/kg bw in rat (reference 7.2.1 -1 to 7.2.1 -6).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch Code 4
Additional information
The available in vivo data on mice and rats (publications) were used to assess the acute oral toxicity in a weight of evidence approach. In a metabolism, pharmacokinetic and toxicity study in rats (reference 7 .2.1 -1), an LD50 of > 6000 mg/kg bw was determined. In mice, an LD50 of 7888 mg/kg bw was determined (reference 7.2.1 -2). In other studies, comparable LD50 values were determined in mice (LD50 = 6400 mg/kg bw; reference 7.2.1 -6, LD50 = 4400 mg/kg bw; reference 7.2.1 -4, LD50 > 3000 mg/kg bw, reference 7.2.1 -5) or rats (LD50 = 5050 mg/kg bw; reference 7.2.1 -3, LD50 > 6000 mg/kg bw; reference 7.2.1 -5), respectively. Since all available data indicate a low acute oral toxicity potential of the test item in different species, the whole data set is regarded as sufficient to cover the endpoint acute oral toxicity. Accordingly, the test item is considered to be classified as UN GHS No Category. Therefore no in vivo study was performed recently. This decision is in line with REACH Regulation (EG) No 1907/2006, Annex XI (1) and in the interests of animal welfare (avoidance of unnecessary in vivo experiments).
In conclusion, the determined high LD50 values of the test item indicate a low toxicity and do not warrant a classification for acute oral toxicity (UN GHS: No Category).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test data are suitable for classification
purposes under Regulation 1272/2008 (CLP). As a result the test item is
not considered to be classified for acute oral toxicity under Regulation
(EC) No 1272/2008, as amended for the tenth time in Regulation
(EU) No 2017/776.
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.
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