Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
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:
- 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrol-1,4-dione

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: none
- Available non-GLP studies: none
- Historical human data: none
- (Q)SAR: no reliable (Q)SAR available, e.g. the substance is outside of the applicability domains of the 'Developmental/Reproductive Toxicity library (PG) 1.0.0'
- In vitro methods: no suitable or validated in-vitro methods available
- Weight of evidence: not applicable, as no information on toxicity to reproduction on the respective group of pigments (diketopyrrolopyrrols (DPP)) is available
- Grouping and read-across: not applicable, as no information on toxicity to reproduction on the respective group of pigments (diketopyrrolopyrrols (DPP)) is available
- 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) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
None of the specific adaption rules (8.7.,column 2) on reproductive toxicity applies. The substance is not known to have carcinogenic, mutagenic or developmental toxicity effects, or adverse effects on fertility. In addition, no toxicokinetic data are available to demonstrate no systemic absorption.
The extension of cohort 1B to include the F2 generation is not required as
- the uses do not lead to significant exposure of consumer and professionals,
- the substance is not genotoxic,
- there are no indications that the internal dose of the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure
- there are no indications of one or more relevant modes of action related to endocrine disruption
In addition, none of the requirements to trigger concerns calling for cohorts 2A/2B and 3 are met.


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: none

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:

- Premating exposure duration for parental (P0) animals: The standard pre-mating exposure duration of two weeks (see OECD TG 443) will be used, as there are no indications from available studies that would require a longer pre-mating period.
- Basis for dose level selection: As relevant toxicokinetic data are not available, doses will be selected based on the available toxicity data of the substance.
- Inclusion/exclusion of extension of Cohort 1B: The extension of cohort 1B to include the F2 generation is not required as the uses do not lead to significant exposure of consumer and professionals, the substance is not genotoxic, there are no indications that the internal dose of the substance and/or any of its metabolites will reach a steady state in the test animals only after an extended exposure and as there are no indications of one or more relevant modes of action related to endocrine disruption
- Termination time for F2: not applicable as cohort 1B will not be extended to include F2
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: Cohorts 2A/2B will not be included as none of the requirements, i.e. relevant existing information, specific relevant mechanisms/modes of action or existing relevant information from structurally analoguos substances, triggering concerns that justify inclusion of these cohorts are met.
- Inclusion/exclusion of developmental immunotoxicity Cohort 3: Cohort 3 will not be included as none of the requirements, i.e. relevant existing information, specific relevant mechanisms/modes of action or existing relevant information from structurally analoguos substances, triggering concerns that justify inclusion of this cohort are met.
- Route of administration: oral gavage
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals [if applicable]: All other considerations will be made according to the requirements of the OECD TG 443.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): C.I. Pigment Red 254 (Cinilex® DPP Red SR1C)
- Substance type: pigment
- Physical state: powder (red)
- Analytical purity: > 99%, typically 99.4%
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion