Registration Dossier

Administrative data

Description of key information

NOAEL, rat (oral), 3 month; systemic toxicity: 5 mg/kg bw/d 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
5 mg/kg bw/day

Mode of Action Analysis / Human Relevance Framework

Additional information

As no repeated dose toxicity studies are available for di-tridecamine, read-across with the structural analogue tridecylamine (TDA) is performed. The subchronic toxicity of TDA was tested under GLP conditions in a 90 day oral gavage study according to OECD TG 408 in male and female Wistar rats (BASF AG, 2004; Val. 2). Additionally, the effects on the male and female reproductive organs were examined. The tested dose levels of 5, 15, and 45 mg/kg bw/day were selected based on the results of a 4-week range finding study that was conducted with 5 rats per sex and dose at 25, 50, and 75 mg/kg bw/day.

 

No changes were seen in animals at 5 mg/kg bw/day. In the groups at 15 mg/kg bw/day, signs of toxicity included statistically significantly reduced body weights, body weight changes, and reduced food efficiency in males during the first 14 days of treatment, and respiration sounds and labored respiration in 4/10 male and in 4/10 females starting from day 32 until the end of the study. Similar findings, but in higher frequency and severity were seen in the groups at 45 mg/kg bw/day. This dose also led to increased relative liver weights in females and was lethal for one male and one female animal. Sensimotor tests and reflexes were not affected by the treatment in any group except for the landing foot-splay test in high-dose males, probably due to the generally poor condition of these animals. Ophthalmological examinations revealed no substance-related effects. Clinical pathology, i.e. hematology, clinical chemistry, and urinalysis, showed no treatment-related effects as compared to the control animals. Histopathological examinations revealed no changes beyond the normal.

 

Overall, signs of toxicity were seen in groups at 15 and 45 mg/kg bw/day. The NOAEL for systemic toxicity was 5 mg/kg bw/day. Sperm quality parameters and the estrous cycle were not affected at 45 mg/kg bw/day.

Justification for classification or non-classification

Based on the available information information on the read-across substance tridecylamine, di-tridecamine does not need to be classified for repeated dose toxicity according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.