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Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive toxicity - fertility - oral/dermal/inhalation: Study was waived; The substance is considered not to exert any reproductive toxic effects (fertility).

Link to relevant study records

Referenceopen allclose all

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
other justification
Justification for data waiving:
other:
Reproductive effects observed:
not specified
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

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Pigment Violet 23

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no GLP-Studies available
- Available non-GLP studies: There are no non-GLP-Studies available
- Historical human/control data. There are no human data available
- (Q)SAR: No validated QSAR-models exist for reproductive toxicity endpoints
- In vitro methods: No validated in vitro-models exist for reproductive toxicity endpoints
- Weight of evidence: There is insufficient information available on possible reproductive effects of the registered substance
- Grouping and read-across: There is insufficient information available on possible reproductive effects of the registered substance and structural analogues.
- 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:
- Specific adaptions of annexes 6 to 10 are not applicable because there are no indications that the substance is mutagenic, carcinogenic or a reproductive toxicant. Though the registered substance as an organic pigment is considered non-reactive, extremely poorly soluble, and hence not bio-available, there are insufficient data available to prove this assumption.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
There is a study according to OECD 421 going on, which will be used to determine the dose range and the final design of the planned study. Results of this OECD 421 study will be available in about 3 months (End of July 2021)
Qualifier:
according to guideline
Guideline:
EU Method B.56 (Extended One-Generation Reproductive Toxicity Study)
GLP compliance:
yes (incl. QA statement)
Justification for study design:
The study design is not yet fixed. The final study design will be determined based on the results of an ongoing OECD 421 study.
As there are no indications of reproduction toxicity in available data and the material is considered not-bio-available, the basic design of the study is considered probable.

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: 14 days
- Basis for dose level selection: a dose range finding study (OECD 421) is ongoing
- Inclusion/exclusion of extension of Cohort 1B : no extension of cohort 1B
- Termination time for F2: no F2-generation
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: not yet determined
- Inclusion/exclusion of developmental immunotoxicity Cohort 3: not yet determined
- Route of administration: oral gavage
Species:
rat
Sex:
male/female
Route of administration:
oral: gavage
Control animals:
yes, concurrent vehicle
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Reproductive toxicity - developmental toxicity / teratogenicity - oral/dermal/inhalation: Study was waived; The substance is considered not

to exert any reproductive toxic effects.

Link to relevant study records

Referenceopen allclose all

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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. QA statement)
Species:
rat
Abnormalities:
not specified
Developmental effects observed:
not specified
Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
This study will only be performed when deemed necessary after the completion of a study of the same type in the first species

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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

It can reasonably be deduced that Pigment Violet 23 does not cause toxicity to reproduction and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because

- Pigment Violet 23 is a chemically unreactive substance,

- Pigment Violet 23 can be considered insoluble because it has an extremely low solubility in water and n-octanol,

- due to its extremely low solubility, it is unlikely that Pigment Violet 23 becomes systemically bioavailable after oral, dermal or inhalation exposure,

- Pigment Violet 23 caused no systemic toxic effects in a 28-day oral gavage study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- Pigment Violet 23 does not have to be classified as skin sensitizing or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.

It can therefore be concluded with sufficient certainty that Pigment Violet 23 will not cause toxicity to reproduction and that testing is not scientifically necessary.

 

It can reasonably be deduced that Pigment Violet 23 does not cause developmental toxicity (including effects on breast-fed babies via the mother's milk) and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because

- Pigment Violet 23 is a chemically unreactive substance,

- Pigment Violet 23 can be considered insoluble because it has an extremely low solubility in water and n-octanol,

- due to its extremely low solubility, it is unlikely that Pigment Violet 23 becomes systemically bioavailable or enters the mother's milk after oral, dermal or inhalation exposure,

- Pigment Violet 23 caused no systemic toxic effects in a 28-day oral gavage study in rats (NOAEL 1000 mg/kg/day) and there was no evidence of absorption of the substance,

- Pigment Violet 23 does not have to be classified as skin sensitizing or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.

It can therefore be concluded with sufficient certainty that Pigment Violet 23 will not cause developmental toxicity and that testing is not scientifically necessary.

Additional information