Registration Dossier

Administrative data

Description of key information

Read-across from analogue:

Skin irritation:

Not irritating, key study with 6 albino rabbits following 24 hours occluded contact with the test material according to the procedure described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404).

Eye irritation:

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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 similar to OECD Guideline 404) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
no
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Remarks on result:
no indication of irritation

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, the read-across approach is applied and the substance Ultramarine Violet is considered to be not irritating.

Interpretation of results:
GHS criteria not met
Remarks:
not irritating
Conclusions:
Based on the experimental results obtained with the analogue, the read-across approach is applied and the substance Ultramarine Violet is considered to be not irritating.
Executive summary:

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING:
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes.
Reason / purpose:
data waiving: supporting information
Reason / purpose:
data waiving: supporting information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Read-across from analogue:

Skin irritation:

Key study. Study with 6 albino rabbits following 24 hours occluded contact with the test material.

The procedure used was described in the U.S.Federal Register, 1973, Vol.38, No.187, Section 1500:41 (similar to OECD Guideline 404).

The result was as follows:

0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.

Eye irritiation:

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.

Justification for classification or non-classification

Based on the available data, the substance is not classified.