Registration Dossier

Administrative data

Description of key information

A study on the analogue substance was assessed for repeated dose oral toxicity according to OECD 408.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
1 409.7 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

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

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In lieu of repeat dose data on nonanal, data are presented for the analogue substance dodecanal. The dodecanal NOAEL was 20000 ppm, equivalent to 1409.7 mg/kg bw/d.

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD (Q)SAR Toolbox. From the profile, it can be seen that the two substances share structural similarities and also "mechanistic action" similarities which are both general and endpoint specific. Therefore read-across is justified.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The test substance was assessed for repeated oral dose toxicity according to OECD 408.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
In line with Column 2, point 8.6.1, Annex VIII of Regulation 1907/2006, a repeat-dose inhalation study does not need to be performed as the substance has low vapour pressure and high melting point, so the potential for the generation of inhalable forms is low. The use of this substance should not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and a repeat-dose inhalation study is not required. As an objective of Regulation EC No. 1907/2006 is to reduce, replace or refine animal testing, based on the above information and information in this dossier, it can be reasonably expected that inhalation exposure is not expected and as such, further investigation using vertebrate animals is therefore considered unnecessary.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
In line with Column 2, point 8.6.1, Annex VIII of Regulation 1907/2006, a repeat-dose inhalation study does not need to be performed as the substance has low vapour pressure and high melting point, so the potential for the generation of inhalable forms is low. The use of this substance should not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and a repeat-dose inhalation study is not required. As an objective of Regulation EC No. 1907/2006 is to reduce, replace or refine animal testing, based on the above information and information in this dossier, it can be reasonably expected that inhalation exposure is not expected and as such, further investigation using vertebrate animals is therefore considered unnecessary.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The physicochemical and toxicological properties suggest low potential for significant rate of absorption through the skin. Furthermore the results of laboratory animal studies show low acute dermal toxicity. In a 90 - days repeated dose study on the analogue substances, undec10-enal and Dodecanal, via dietary administration, the test substance did not exacerbate systemic toxicity effects which suggest bioavailability is low, therefore there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration. Furthermore, contact with neat substance will be prevented by risk mitigation measures in the modern industrial setting. Further investigation using vertebrate animals is therefore considered unnecessary.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
The physicochemical and toxicological properties suggest low potential for significant rate of absorption through the skin. Furthermore the results of laboratory animal studies show low acute dermal toxicity. In a 90 - days repeated dose study on the analogue substance, undec10-enal, via dietary administration, the test substance does not exacerbate systemic toxicity effects which suggest bioavailability is low, therefore there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration. Furthermore, contact with neat substance will be prevented by risk mitigation measures in the modern industrial setting. Further investigation using vertebrate animals is therefore considered unnecessary.

Justification for classification or non-classification

The analogue substance, Dodecanal, was assessed for repeated dose oral toxicity according to OECD 408. The No Observed Adverse Effect Level (NOAEL) for the rat was considered to be 20000 ppm, equivalent to 1409.7 mg/kg bw/d.