Registration Dossier
Registration Dossier
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EC number: 700-582-2 | CAS number: 30392-50-8
Endpoint summary
Administrative data
Description of key information
The test substance Dibenzylaminoacetylbrenzkatechin * HCl was investigated for acute oral toxicity in male and femal Wistar rats.
Based on a dose range finding study the acute oral toxicity of Dibenzylaminoacetylbrenzkatechin * HCl was tested only at a dose level of 2000 mg/kg body weight (limit test). According to OECD Guideline 401 (adopted: February 24th 1987) no fully study has to be carried out, if no compound-related mortality is produced in a limit test. The same holds true for currently valid guidance documents such as e.g. OEDC 423 (2001).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Study performed according OECD Guideline 401 (conducted in compliance with GLP). Deficiencies: No deficiencies in comparison to OECD Guideline 401 (Adopted: February 24th 1987). Therefore no further discussion of the results is considered to be necessary.
Justification for classification or non-classification
Because the substance 2-[bis(phenylmethyl)amino]-1-(3,4,-dihydroxyphenyl)-ethanone hydrochloride is handled as an on-site isolated intermediate under strictly controlled conditions as defined in 1907/2006/EEC (REACH) Article 3 (15b), only all the available existing information without any additional testing on (amongst others) human health have to be included in the registration dossier as stated in 1907/2006/EEC (REACH) Article 17(2).
The limit test presented in this dossier, which was performed to investigate the acute oral toxicity of 2-[bis(phenylmethyl)amino]-1-(3,4,-dihydroxyphenyl)-ethanone hydrochloride, is the only existing available information (to the best of our knowledge) on the acute toxicity of this substance.
Therefore only a conclusion on the acute oral toxicity of 2-[bis(phenylmethyl)amino]-1-(3,4,-dihydroxyphenyl)-ethanone hydrochloride can be drawn, which is the following:
Based on the results obtained in the study the median lethal dose value (LD50) of Dibenzylaminoacetylbrenzkatechin * HCl for male and female Wistar rats is greater than 2000 mg/kg body weight. Based on this result Dibenzylaminoacetylbrenzkatechin * HCl is neither classified as very toxic, toxic or harmful according to the Directive 67/548/EEC (DSD), nor as oral toxic category 1 to 4 according to the Regulation 1272/2008/EC (CLP).
Therefore in section “2.1 Classification and Labelling GHS” and “2.2 Classification and Labelling DSD –DPD” the statement “conclusive but not sufficient for classification” has been selected as the reason for no classification.
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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