Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Remarks:
Prenatal developmental toxicity study
Type of information:
experimental study planned
Justification for type of information:
Public substance name: 1,1-Dimethyl-2-phenylethyl acetate
EC Number: 205-781-3
CAS Number: 151-05-3

Date of considerations: 16 March 2017

 Hazard endpoint for which vertebrate testing was proposed:

Developmental toxicity / teratogenicity

 Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):

 available GLP studies

No available GLP studies on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

 available non-GLP studies

No available non-GLP studies on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

 historical human data

No human data suggesting Developmental toxicity are available for this substance.
According to the EFSA Journal (2009) 1033, 7-19, the estimated intakes of 1,1-Dimethyl-2-phenylethyl acetate based on Maximised Survey-derived Daily Intake (MSDI) approach are 0.34 μg/capita/day (EU), 0.04 μg/capita/day (USA), respectively. And its threshold of concern is 1800 μg/person/day.

 (Q)SAR

No validated (Q)SAR exists for this endpoint. There is no known mode of action for 1,1-Dimethyl-2-phenylethyl acetate causing Developmental toxicity effects.

 in vitro methods

In accordance with ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a. With regards to studies for Developmental 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 labeling and/or risk assessment.

 weight of evidence

No available ‘weight of evidence’ data on the substance for the endpoint ‘Developmental toxicity / teratogenicity’.

 grouping and read-across

No data exists on analogous substances. It is the intention to use test data from 1,1-Dimethyl-2-phenylethyl acetate for further read-across to similar substances thus avoiding the need to perform further testing.

 substance-tailored exposure driven testing [if applicable]

Not applicable

 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 (instruction: free text):

Adaptation options as defined in Annexes VI to X were not applicable for this substance and this endpoint.

However, since the substance is widely used as food additive, Developmental toxicity is unlikely and a test could be avoided by allowing an adaptation on this basis and outside of Annexes VI to X.

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Qualifier:
according to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
other: CRL Sprague-Dawley CD® IGS rats

Results and discussion

Applicant's summary and conclusion