Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Read-across from analogue:

Key studies:

- Key studies: Two studies on Bacterial reverse mutation assay (Ames test) according to OECD guideline 471.

Results: negative

- Key study: In vitro mammalian chromosome aberration test according to OECD guideline 473.

Result: negative

- Key study: In vitro mammalian cell gene mutation test according to OECD guideline 476.

Result: negative

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue with EC number 309-928-3 (Ultramarine Blue) shares the same functional group with the substance EC number 701-186-2 (Ultramarine Violet) and the results can be extrapolated to Ultramarine Violet.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACHThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)Ultramarine blue, C.I. Pigment blue 29: CAS number: 57455-37-5, EC name: Silicic acid, aluminum sodium salt, sulfurized, EC number: 309-928-3 Ultramarine Violet, C.I. Pigment Violet 15: CAS number: 12769-96-9, EC name: sodium aluminosilicate violet, EC number: 701-186-2. No relevant impurities.
3. ANALOGUE APPROACH JUSTIFICATIONThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
4. DATA MATRIX (Please, see attached document "Reporting Format for the analogue approach")
Reason / purpose:
read-across source
Principles of method if other than guideline:
Read-across approach from published data (method OECD Guideline 471) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Interpretation of results:negative

The analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).

 

The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.

Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be not mutagenic.

Conclusions:
Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be not mutagenic.
Executive summary:

Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be not mutagenic.

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue with EC number 309-928-3 (Ultramarine Blue) shares the same functional group with the substance EC number 701-186-2 (Ultramarine Violet) and the results can be extrapolated to Ultramarine Violet.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACHThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)Ultramarine blue, C.I. Pigment blue 29: CAS number: 57455-37-5, EC name: Silicic acid, aluminum sodium salt, sulfurized, EC number: 309-928-3 Ultramarine Violet, C.I. Pigment Violet 15: CAS number: 12769-96-9, EC name: sodium aluminosilicate violet, EC number: 701-186-2. No relevant impurities.
3. ANALOGUE APPROACH JUSTIFICATIONThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
4. DATA MATRIX (Please, see attached document "Reporting Format for the analogue approach")
Reason / purpose:
read-across source
Principles of method if other than guideline:
Read-across approach from published data (method OECD Guideline 473) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test
Key result
Species / strain:
other: Chinese Hamster cells (CHL/IU)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

The analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).

 

The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.

Based on the experimental results obtained with the analogue according to OECD 473, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Conclusions:
Based on the experimental results obtained with the analogue according to OECD 473, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.
Executive summary:

Based on the experimental results obtained with the analogue according to OECD 473, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue with EC number 309-928-3 (Ultramarine Blue) shares the same functional group with the substance EC number 701-186-2 (Ultramarine Violet) and the results can be extrapolated to Ultramarine Violet.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACHThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)Ultramarine blue, C.I. Pigment blue 29: CAS number: 57455-37-5, EC name: Silicic acid, aluminum sodium salt, sulfurized, EC number: 309-928-3 Ultramarine Violet, C.I. Pigment Violet 15: CAS number: 12769-96-9, EC name: sodium aluminosilicate violet, EC number: 701-186-2. No relevant impurities.
3. ANALOGUE APPROACH JUSTIFICATIONThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
4. DATA MATRIX (Please, see attached document "Reporting Format for the analogue approach")
Reason / purpose:
read-across source
Principles of method if other than guideline:
Read-across approach from a study report (method OECD Guideline 471 and EU method B.13/B.14) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Interpretation of results: negative

The analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).

 

The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.

Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Conclusions:
Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.
Executive summary:

Based on the experimental results obtained with the analogue according to OECD 471, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue with EC number 309-928-3 (Ultramarine Blue) shares the same functional group with the substance EC number 701-186-2 (Ultramarine Violet) and the results can be extrapolated to Ultramarine Violet.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACHThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)Ultramarine blue, C.I. Pigment blue 29: CAS number: 57455-37-5, EC name: Silicic acid, aluminum sodium salt, sulfurized, EC number: 309-928-3 Ultramarine Violet, C.I. Pigment Violet 15: CAS number: 12769-96-9, EC name: sodium aluminosilicate violet, EC number: 701-186-2. No relevant impurities.
3. ANALOGUE APPROACH JUSTIFICATIONThe analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.
4. DATA MATRIX (Please, see attached document "Reporting Format for the analogue approach")
Reason / purpose:
read-across source
Principles of method if other than guideline:
Read-across approach from a study report (method OECD Guideline 476) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
yes
Type of assay:
mammalian cell gene mutation assay
Key result
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Interpretation of results: negative
Remarks on result:
other: all strains/ cell type tested

The analogue approach covers the substance Ultramarine Blue (CAS 57455-37-5) and the substance Ultramarine Violet (CAS 12769-96-9).

 

The analogue Ultramarine Blue shares the same functional group with the substance Ultramarine Violet. Therefore, they are expected to be toxicologically equivalent.

Based on the experimental results obtained with the analogue according to OECD 476, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Conclusions:
Based on the experimental results obtained with the analogue according to OECD 476, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.
Executive summary:

Based on the experimental results obtained with the analogue according to OECD 476, the read-across approach is applied and the substance Ultramarine Violet is considered to be negative.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Based on the available data on genetic toxicity in vitro, the substance is considered as negative and therefore, it is not classified.