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Registration Dossier
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EC number: 701-186-2 | CAS number: -
Endpoint summary
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 safe cosmetic in the area around the eyes. This result is supported by public 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
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH: The analogue approach covers the substance Ultramarine Blue (EC nº 701-340-9) and the substance Ultramarine Violet (EC nº 701-186-2).The analogue Ultramarine Blue shares the same structure (Sodalite-type structure (SOD-Zeolite)) 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, EC number: 701-340-9;
Ultramarine Violet, C.I. Pigment Violet 15, EC number: 701-186-2.
No relevant impurities.
3. ANALOGUE APPROACH JUSTIFICATION: The analogue approach covers the substance Ultramarine Blue (EC nº 701-340-9) and the substance Ultramarine Violet (EC nº 701-186-2).The analogue Ultramarine Blue shares the same structure (Sodalite-type structure (SOD-Zeolite)) 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 for cross-reference:
- read-across source
- 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
- 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.
Reference
The analogue approach covers the substance Ultramarine Blue (EC nº 701-340-9) and the substance Ultramarine Violet (EC nº 701-186-2).
The analogue Ultramarine Blue shares the same structure (Sodalite-type structure (SOD-Zeolite)) 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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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 around the eyes. - Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 safe cosmetic in the area around the eyes. This result is supported by public 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.
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