Registration Dossier

Administrative data

Description of key information

Read-across from analogue:

Skin sensitising: Not sensitising

Key study. Study with 20 guinea pigs by application of the test material to the flank for 24 hours with a 25% and 12.5% concentration of the test material, according to procedure described by B.Magnusson and A.M. Kligman (J. Invt. Derm. 1969 52pp.268 -276) (similar to OECD Guideline 406).

The result was as follows: sensitisation rate of 0-8%.


Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No information available
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
12.5% and 25% concentration of the test material
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No visible reactions
Reading:
1st reading
Group:
negative control
Remarks on result:
not measured/tested
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/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, the read-across approach is applied and the substance Ultramarine Violet is considered to be not sensitising.

Interpretation of results:
GHS criteria not met
Remarks:
not sensitising
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 sensitising.
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 sensitising.

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

Justification for classification or non-classification

Based on the available data, the substance is considered as non-sensitising.