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Administrative data

Description of key information

LD50(oral) > 2000 mg/kg bw. (Bioassay, 2012)
LD50(dermal) > 2000 mg/kg bw. (Bioassay, 2012)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral toxicity

In a GLP compliant study, according to OECD guideline 423, the acute oral toxicity of N,N''-Hexane-1,6-diylbis[N'-benzylurea] following a single oral administration in female Wistar rats was investigated (Bioassay, 2012). Two groups of fasted animals (3/group) were treated by gavage with N,N''-Hexane-1,6-diylbis[N'-benzylurea] in olive oil Ph.Eur at a dose level of 2000 mg/kg bw and observed for 14 days. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The mean body weight increased within the normal range throughout the study period. No macroscopic findings were observed at necropsy. The acute oral LD50 of N,N''-Hexane-1,6-diylbis[N'-benzylurea] after single oral administration to female rats is > 2000 mg/kg bw.

Dermal toxicity: 

In a GLP compliant study, according to OECD guideline 402, the acute dermal toxicity of N,N''-Hexane-1,6-diylbis[N'-benzylurea] following a single dermal application in male and female Wistar rats was investigated (Bioassay, 2012). A group animals (5/sex) was dermally exposed to N,N''-Hexane-1,6-diylbis[N'-benzylurea] in olive oil Ph.Eur at a dose level of 2000 mg/kg bw for 24 hours under semi-occlusive dressing and observed for 14 days. All animals survived until the end of the study period. There were no signs of systemic toxicity and no signs of skin effects. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals slightly increased or stagnated during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal LD50 of N,N''-Hexane-1,6-diylbis[N'-benzylurea] after single dermal application in male and female rats was found to be > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity study, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP).