N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Endpoint:

two-generation reproductive toxicity

Data waiving:

other justification

Justification for data waiving:

other:

Reproductive effects observed:

not specified

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Additional information

The substance is not a known genotoxic carcinogen nor is it a known germ cell mutagen. Relevant human exposure to the substance cannot be excluded. However, in silico reproductive toxicity predictions for the substance are available. Therefore, in accordance with column 2 of REACH Annex VIII, the reproductive toxicity study (required in section 8.7.1) does not need to be conducted as information to address the reproductive toxicity of the substance is available.

In accordance with column 1 of REACH Annex IX, the two-generation reproductive toxicity study (required in section 8.7.3) does not need to be conducted at this time as the 90-day repeated-dose study does not indicate adverse effects on reproductive organs or tissues.

Short description of key information:
In accordance with column 2 of REACH Annex VIII, the reproductive toxicity study (required in section 8.7.1) does not need to be conducted as information to address the reproductive toxicity of the substance is available. In accordance with column 1 of REACH Annex IX, the two-generation reproductive toxicity study (required in section 8.7.3) does not need to be conducted at this time as the 90-day repeated-dose study does not indicate adverse effects on reproductive organs or tissues.

Justification for selection of Effect on fertility via oral route:
In accordance with column 1 of REACH Annex IX, the two-generation reproductive toxicity study (required in section 8.7.3) does not need to be conducted at this time as the 90-day repeated-dose study does not indicate adverse effects on reproductive organs or tissues..

Effects on developmental toxicity

Description of key information

In accordance with REACH Annex XI, the pre-natal developmental toxicity study (section 8.7.2) does not appear to be scientifically necessary. The supporting read-across prediction identifies a reproductive toxicity LOEL of 110 mg/kg body wt/day that is suitable for use in risk assessment.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Additional information

In accordance with REACH Annex XI, the pre-natal developmental toxicity study (section 8.7.2) does not appear to be scientifically necessary. The negative QSAR results (S-IN, 2013 - 7.8.2 In silico prediction - QSAR.002) support the prediction of the target substance’s toxicological properties by read-across (S-IN, 2013 - 7.8.1 In silico prediction - read-across.003). Therefore, based on a weight of evidence approach, it is not necessary to conduct a pre-natal developmental toxicity study as the read-across prediction supported by the QSAR conclude that specific reproductive toxicity is unlikely to occur. In addition, the read-across prediction identifies a reproductive toxicity LOEL of 110 mg/kg body wt/day that is suitable for use in risk assessment.

Justification for selection of Effect on developmental toxicity: via oral route:
In accordance with REACH Annex XI, the pre-natal developmental toxicity study (section 8.7.2) does not appear to be scientifically necessary.

Justification for classification or non-classification

The read-across prediction of no specific reproductive toxicity is supported by the QSAR prediction. Therefore, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.7.