Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: reaction mass of beta-phellandrene and d-limonene and l-limonene
- Name of the substance for which the testing proposal will be used [if different from tested substance]

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
No GLP studies are available on the substance for the end point listed above.
- Available non-GLP studies
No non-GLP studies are available on the substance for the end point listed above.
- Historical human data
No historical human data are available on the substance for the endpoint listed above.
- (Q)SAR
Not adequate for the endpoint listed above according to ECHA guidance documents*.
- In vitro methods
No in vitro method is available to address the developmental toxicity.
- Weight of evidence
There are no data to establish a weight of evidence argument.
- Grouping and read-across
There are not enough data on read across analogues to propose a read-across for the endpoint listed above.
- Substance-tailored exposure driven testing [if applicable] Not applicable
- Approaches in addition to above [if applicable] Not applicable
- Other reasons [if applicable] Not applicable
* Chapter R.7 a: Endpoint specific guidance Version 4.1 – October 2015

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Test proposal is fully in line with ECHA guidance document*, and can neither be replaced by in vitro testing nor by using other data from other substances. All possible adaptation possibilities were considered and none was applicable to this substance.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Pre-natal developmental toxicity in rat according to guideline OECD 414.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion