Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxicity to reproduction - fertility (screening)

According to Regulation (EC) No 1907/2006, Annex VIII, 8.7.1, column 2, testing for effects on fertility by a screening test is not required as a test for prenatal developmental toxicity (Annex IX, 8.7.2) is proposed for the structurally related substance erucamide (CAS 112-84-5), which will be used for read-across in accordance with the criteria set out in Annex XI, article 1.5.

Toxicity to reproduction - fertility (two-generation study)

According to Regulation (EC) No 1907/2006, Annex IX, 8.7.3, column 1, a two-generation reproductive toxicity study has to be performed in one species, male and female, using the most appropriate route of exposure, if the 28-day or 90-day studies indicate adverse effects on reproductive organs or tissues. Data on selected reproduction parameters will be provided in the proposed 90-day oral repeated dose toxicity study according to OECD 408, which will be performed with the structurally related substance (Z)-Docos-13-enamide (CAS 112-84-5) in accordance with the criteria for read-across according to Annex XI, article 1.5. To assess the possible effect on reproduction and fertility, additional parameters will be included (extensive gross necropsy and detailed histopathology of male and female reproductive organs and tissues, and sperm parameters). Based on the outcome of the subchronic toxicity study on parameters related to reproduction toxicity, the next steps in the testing strategy will be reconsidered.


Short description of key information:
Waiving - Toxicity to reproduction screening
Waiving - Toxicity to reproduction 2-generation study

Justification for selection of Effect on fertility via oral route:
A repeated dose toxicity study via the oral route according to OECD Guideline 408 with extended standard protocol including fertility parameters and histopathological examination of reproduction organs for the structurally related substance (Z)-Docos-13-enamide (CAS 112-84-5) in compliance with the criteria for read-across according to Annex XI, article 1.5 is proposed. The results of the study will be used to justify the waiving of a 2-generation study for toxicity to reproduction if no adverse effects on reproductive organs or tissues are observed in this study. A screening test for toxicity to reproduction is not required since a prenatal developmental toxicity study for the structurally related substance is proposed, which will be used for read-across based on the analogue approach.

Effects on developmental toxicity

Description of key information
Waiving - (Prenatal) Developmental Toxicity
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Additional information

Toxicity to reproduction - (pre)natal developmental toxicity

According to Regulation (EC) No 1907/2006, Annex IX, 8.7.2, column 1, a pre-natal developmental toxicity study has to be performed in one species via the most appropriate route of administration, having regard to the likely route of human exposure. A pre-natal developmental toxicity study via the oral route according to OECD Guideline 414 for the structurally related substance (Z)-Docos-13-enamide (CAS 112-84-5) is proposed and the generated data will comply with the criteria for read-across according to Annex XI, article 1.5. The results of the study will be used to determine the following steps in the testing regime.


Justification for selection of Effect on developmental toxicity: via oral route:
According to Regulation (EC) No 1907/2006, Annex IX, 8.7.2, column 1, a pre-natal developmental toxicity study has to be performed in one species via the most appropriate route of administration, having regard to the likely route of human exposure. A pre-natal developmental toxicity study via the oral route according to OECD Guideline 414 for the structurally related substance (Z)-Docos-13-enamide (CAS 112-84-5) is proposed and the generated data will comply with the criteria for read-across according to Annex XI, article 1.5. The results of the study will be used to fulfil the data requirements for this endpoint for docosanamide (CAS 3061-75-4).

Justification for classification or non-classification

Additional information