N,N-dibutylformamide

Endpoint summary

Description of key information

According to REGULATION (EC) No 1907/2006, Annex XI, section 3, repeated dose toxicity testing in accordance with Annes VIII, section 8.6 can be omitted, as relevant human exposure can be excluded; based on the exposure scenario(s) developed in the Chemical Safety Report.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

exposure considerations

Justification for data waiving:

a short-term toxicity study does not need to be conducted because relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

exposure considerations

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

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

No data available.

Additional information

Exposure based adaptation of information requirements:

Testing in accordance with sections 8.6 (repeated dose toxicity) and 8.7 (reproductive toxicity) of REACH Annex VIII may be omitted if relevant human exposure can be excluded in accordance with REACH Annex XI section 3. In accordance with section 3.2 (b) of Annex XI, testing can be omitted where the substance is not incorporated in an article and the manufacturer/importer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.

The substance DBF is manufactured and used under strictly controlled conditions over the entire lifecycle. Possible exposure is limited to sampling and cleaning and maintenance work under strictly controlled conditions with limited exposure probability: Only a small, well-defined and trained group of workers is involved in these processes and the possible exposure occasionally to low levels of DBF is considered controlled using appropriate risk management measures to minimize exposure.

Therefore, on the basis of the described process conditions, testing of DBF for repeated dose toxicity and/or toxicity to reproduction should not be performed since the criteria of exposure-based adaptation of information requirements according to Annex XI section 3.2 (b) are clearly met.

An adequate justification and documentation for this adaptation is attached in the respective field in IUCLID section 7.5.1: "Attached justification". The relevant exposure scenarios are provided in the CSR, attached in IUCLID section 13.1.

 

 

 

Justification for classification or non-classification

Due to the exposure based adaptation of information requirements, no data on specific organ toxicity after repeated exposure are available for DBF. Thus, no classification is warranted acccording to REACH Regulation (EC) No 1907/2006.