2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
C.I. Pigment Violet 23 nanoform

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:
There are no Studies available for this endpoint
- Available non-GLP studies
There are no Studies available for this endpoint
- Historical human/control data
There are no data available for this endpoint
- (Q)SAR
The test material is outside the applicability domain of these models
- In vitro methods
There are no in vitro methods available for this endpoint
- Weight of evidence
There are no data available for this endpoint
- Grouping and read-across: There is insufficient information available on possible reproductive effects of the registered substance and structural analogues.

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:
-The study according to OECD TG 414 in the rat is a standard requirement of REACH at the applicable tonnage level. None of the specific conditions set out in column 2 are completely applicable. Nevertheless, we are, based on our knowledge of the test material as well as the whole group of organic pigments, convinced that the test material is insoluble and not bioavailable and that, therefore, the results of this study could be predicted with sufficient confidence. However, we did not succeed in convincing ECHA as this specific situation is not reflected in the standard set by column 2 of the annexes.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.0³,¹⁹.0⁵,¹⁷.0⁶,¹⁴.0⁷,¹².0²³,³⁵.0²⁴,³².0²⁵,³⁰]hexatriaconta-1(36),2,5,7(12),8,10,14,16,18,20,23(35),24(32),25,27,29,33-hexadecaene

EC Number:

606-790-9

Cas Number:

215247-95-3

Molecular formula:

C34H22Cl2N4O2

IUPAC Name:

2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.0³,¹⁹.0⁵,¹⁷.0⁶,¹⁴.0⁷,¹².0²³,³⁵.0²⁴,³².0²⁵,³⁰]hexatriaconta-1(36),2,5,7(12),8,10,14,16,18,20,23(35),24(32),25,27,29,33-hexadecaene

Test material form:

solid: nanoform

Test animals

Species:

rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified