Ethyl 4-oxovalerate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

The potential toxicity to reproduction of the test substance was evaluated by considering its analogue substances, due to the absence of available data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

All the information available on the reproductive toxicity of the similar substances was summarized in the file attached below.

Effects on developmental toxicity

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

The potential of the substance to cause developmental toxic effects was evaluated by considering data on the Similar Substances, due to the absence of data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

All the information available on the developmental toxicity of the rest of the similar substances was summarized in the file attached below.

Justification for classification or non-classification

No significantly adverse effects were observed during available experimental data.

According to the CLP Regulation (EC) No. 1272/2008, the following categories for reproductive toxicants are available:

- Category 1: Known or presumed human reproductive toxicant - Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. The classification of a substance is further distinguished on the basis of whether the evidence for classification is primarily from human data (Category 1A) or from animal data (Category 1B).

- Category 1A: Known human reproductive toxicant - The classification of a substance in this Category 1A is largely based on evidence from humans.

- Category 1B: Presumed human reproductive toxicant - The classification of a substance in this Category 1B is largely based on data from animal studies. Such data shall provide clear evidence of an adverse effect on sexual function and fertility or on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary nonspecific consequence of other toxic effects. However, when there is mechanistic information that raises doubt about the relevance of the effect for humans, classification in Category 2 may be more appropriate.

- Category 2: Suspected human reproductive toxicant - Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1. If deficiencies in the study make the quality of evidence less convincing, Category 2 could be the more appropriate classification. Such effects shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects.

 

The substance is not classified as a Reproductive toxicant based on the available experimental data