Registration Dossier

Administrative data

Description of key information

Read-across from analogue:

Key studies:

Oral repeated dose 90-day toxicity study: Test method is similar to OECD guideline 408. No GLP study.

Combined repeated dose and reproduction / developmental screening: OECD guideline 422. GLP study.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
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 408) on the analogue EC number 309-928-3 (Reporting format for the analogue approach is attached). Please, see CSR appendix I.
GLP compliance:
no
Key result
Dose descriptor:
NOAEL
Effect level:
>= 50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality
Critical effects observed:
not specified

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 NOAEL for the substance Ultramarine Violet is considered to be 50 mg/kg bw/day.

Conclusions:
Based on the experimental results obtained with the analogue, the read-across approach is applied and the NOAEL for the substance Ultramarine Violet is considered to be 50 mg/kg bw/day.
Executive summary:

Based on the experimental results obtained with the analogue, the read-across approach is applied and the NOAEL for the substance Ultramarine Violet is considered to be 50 mg/kg bw/day.

Endpoint conclusion
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Justification for classification or non-classification

Oral repeated dose toxicity (90 -day study): NOAEL= 50 mg/kg bw/day. The substance is not classified.