Registration Dossier

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).