Registration Dossier
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EC number: 203-149-1 | CAS number: 103-83-3
Endpoint summary
Administrative data
Description of key information
There are subacute oral toxicity studies available in rats dosed with N,N-Dimethylbenzylamine up to 400 mg/kg bw/day by gavage for 28 days resulting in a NOAEL of 150 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
ORAL ADMINISTRATION
There is no sub-chronic study available. In accordance with section 1 of REACH Annex XI, a sub-chronic repeated dose toxicity study is not required.
There are 2 sub-acute oral studies available which are performed according the respective guideline and in which the test substance
was applied by gavage to male and female rats in dosages of 0, 6, 30, 150, 200 mg/kg bw/day (BG Chemie 1988, 1990) or 0, 50, 100, 200, 400 mg/kg bw/day (MHLW 1997), respectively. In addition, rats of the control group and rats treated with 200 and 400 mg/kg bw/day were observed after termination of treatment for further 2 weeks (recovery group, MHLW 1997).
Mortalities of both males and females receiving 400 mg/kg were observed from week 2. Miosis and salivation was observed in those rats receiving 200 and 400 mg/kg bw/day. The 150 mg/kg bw/day males had slightly higher testis weights than the controls. However, there was no histopathological correlate. In male and female animals dosed with 100 mg/kg bw/day miosis was the only observed finding . There were no differences between controls and male and female rats dosed with 50, 30 or 6 mg/kg bw/day. Thus, the overall NOAEL is considered to be 150 mg/kg bw/day
Based on these unspecific findings in the available subacute studies it is not assumed that a longer duration of treatment would substantially change the assessment of the substance. Therefore, taking also into consideration the need to balance the value of information generation by animal testing with animal welfare a subchronic (90-days) repeated dose toxicity study is not a priority.
DERMAL APPLICATION
There are no data available
INHALATION EXPOSURE
There are no valid studies available
Justification for classification or non-classification
Based on the available data, no classification is required according to the classification criteria 67/548/EWG and
EU Regulation 1272/2008 (CLP/GHS).
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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