Registration Dossier

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Remarks:
based on test type (migrated information)
Type of information:
experimental study planned
Study period:
An OECD test guideline 443, Extended One-Generation Reproduction Toxicity Study in the rat by the oral route of exposure is proposed as per REACH Annex X, Section 8.7.3. The test period will be established once the ECHA approves this Test Plan.
Justification for type of information:
Hazard endpoint for which vertebrate testing was proposed:
Reproductive toxicity (extended one-generation reproductive toxicity study) with the registered substance.

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information:

available GLP studies
No available GLP studies on the substances for the endpoint ‘reproductive toxicity’.

available non-GLP studies
No reliable non-GLP studies are avaialable for the endpoint ‘ reproductive toxicity’.

historical human data
No human data suggesting reproductive toxicity are available for this substance.

(Q)SAR
No validated (Q)SAR’s exist for this endpoint for this substance

in vitro methods
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment , chapter R7a. With regards to in vitro studies for reproductive toxicity, the regulatory acceptance of these studies and approaches to replace the animal testing for reproductive toxicity has not been achieved as they do not provide equivalent information and thus, cannot be used alone for classification and labelling and/or risk assessment.

weight of evidence
No additional studies t provide any weight of evidence.

grouping and read-across
No suitable structural analogues exist for this substance.

substance-tailored exposure driven testing [if applicable]
Based on existng exposure senario information 2,3-epoxypropyl neodecanoate does not qualify for this exemption.

[approaches in addition to above [if applicable]
Not applicable

other reasons [if applicable]
Not applicable

Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable:
Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
(a) the substance does not have uses leading to significant exposure of consumers or professionals, taking into account, interalia, consumer exposure from articles
(b) none of the following conditions are met:
— the substance displays genotoxic effects in somatic cell mutagenicity tests in vivo which could lead to classifying it as Mutagen Category 2, or
— there are indications that the internal dose for the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure, or
— there are indications of one or more relevant modes of action related to endocrine disruption from available in vivo studies or non-animal approaches.

An Extended One-Generation Reproductive Toxicity Study including cohorts 2A/2B (developmental neurotoxicity) is not proposed by the registrant in accordance with Article 40 or 41, in case of particular concerns on (developmental) neurotoxicity justified by the following:
— existing information on the substance itself derived from relevant available in vivo or non-animal approaches does not indicate developmental neurotoxicity in studies on adult animals or animals exposed prenatally), or
— specific mechanisms/modes of action of the substance does not have an association with (developmental) neurotoxicity, or
— existing information on effects caused by substances structurally analogous to the substance being studied, do not suggest such effects or mechanisms/modes of action.

An Extended One-Generation Reproductive Toxicity Study including cohort 3 (developmental immunotoxicity) is not proposed by the registrant in accordance with Article 40 or 41, in case of particular concerns on (developmental) immunotoxicity justified by any of the following:
— existing information on the substance itself derived from relevant available in vivo or non-animal approaches does not indicate developmental immunotoxicity, or
— specific mechanisms/modes of action of the substance does not have an association with (developmental) immunotoxicity, or
— existing information on effects caused by substances structurally analogous to the substance being studied, do not suggest such effects or mechanisms/modes of action.

Other studies on developmental neurotoxicity and/or developmental immunotoxicity instead of cohorts 2A/2B (developmental neurotoxicity) and/or cohort 3 (developmental
immunotoxicity) of the Extended One-Generation Reproductive Toxicity Study do not exists to clarify the concern on developmental toxicity.

A two-generation reproductive toxicity studies (B.35, OECD TG 416) was not initiated before 13 March 2015.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: Liquid at room temperature.
Details on test material:
As per IUCLID5 Sections 1.1, 1.2. and 1.4.

Test animals

Species:
rat

Administration / exposure

Route of administration:
other: Most relevant route of exposure.

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion