Registration Dossier

Administrative data

Description of key information

Since no reliable repeated dose toxicity studies on tri-n-butylamine are available, a sub-chronic toxicity study (90 -day) will be performed.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
There are only studies of insufficient reliability available to cover this endpoint

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Study duration:
subchronic
Species:
rat
Quality of whole database:
There is only a study of insufficient reliability available to cover this endpoint

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
There is only a study of insufficient reliability available to cover this endpoint

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

As there is no evidence for species differences in MoA or species specific activities the available data are regarded as relevant for humans.

Additional information

There is no reliable repeated dose study on tri-n-butylamine [TnBA] available. Some information is available from a reliable developmental toxicity study in rats, which is further discussed in section 7.8. The maternal NOAEL was 45 mg/kg bw, but the exposure period is short (10 days in this case) in developmental toxicity studies. Moreover, the examinations focus on reproduction and developmental effects rather than systemic repeated dose effects. The long-term oral studies conducted by Din Min in rats and rabbits are not valid due to inadequate test design and reporting. Also other studies on repeated dose toxicity performed after oral, inhalation or dermal exposure do not fulfill todays test guideline requirements are not sufficient for evaluation of repeated dose toxicity of the submission substance. Therefore, a repeated dose toxicity study has been requested by ECHA.

 

Justification for classification or non-classification

In the absence of reliable studies on repeated dose toxicity no classification according to Regulation (EC) No 1272/2008 is possible due to a lack of data.