N1,N3-diallylpropane-1,3-diamine dihydrochloride

Endpoint summary

Description of key information

Repeated dose toxicity studies by the oral, inhalation and dermal routes do not need to be conducted because the substance is only manufactured and used under strictly controlled conditions during its whole lifecycle and thus this endpoint does not need to be further investigated. For further details please refer to the report "Exposure based adaptation information - N1,N3-diallylporpane-1,3-diamine dihydrochloride" attached in IUCLID Chapter 13.

However, according to the Commission Regulation (EU) 2021/979 of 17 June 2021, “Testing in accordance with Section 8.6.1 of Annex VIII may be omitted only for registrants producing less than 100 tonnes per year per manufacturer or importer, based on the exposure scenario(s) developed in the Chemical Safety Report”. This implies that testing in accordance with Section 8.6.1 is required for tonnages of >100 tonnes per year regardless of exposure. Therefore, a study according to OECD guideline 407 is initiated and will be submitted mid-2022.

Key value for chemical safety assessment

Toxic effect type:

dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

sub-chronic toxicity: oral

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

sub-chronic toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

sub-chronic toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Reference 1

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