Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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 (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 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.