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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

NOAEL = 1000 mg/kg bw/day upon 28 days exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
The complete read across justification is detailed in section 13. Test substance is an isomer of the substance under registration; structural difference is not expected to significantly impact the toxicity potential. Source study has reliability 4: only limited information available from a migrated NONS file, as per Article 25(3) request.
Principles of method if other than guideline:
No information on the method is available.
GLP compliance:
not specified
Duration of treatment / exposure:
28 days
Dose descriptor:
NOAEL
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Critical effects observed:
not specified
Conclusions:
NOAEL = ca. 1000 mg/kg bw/day
Executive summary:

Method

No information on the method is available. Information derived from migrated NONS file, as per Article 25(3) request, permission to refer granted by ECHA.

 

Results

NOAEL = ca. 1000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on acute toxicity of Direct Blue 273 was available, thus a read across approach was followed. In particular, available information on Similar Substance 01, i.e. an isomer of Direct Blue 273, was used in the assessment.

Based on the structural similarity, the read across approach was considered as appropriate; further details are included in section 13.

Information on the Similar Substance 01 derived from migrated NONS file with permission to refer granted by ECHA. Details on testing method, animals and procedures are lacking.

 

Repeated dose toxicity: oral

In the test conducted on Similar Substance 01 for 28 days, a NOAEL of 1000 mg/kg bw was found.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), the threshold for classification upon a 28 days exposure is 300 mg/kg bw/day.

Due to the lack of adverse effect up to 1000 mg/kg bw/day, this dose was identified as NOAEL. Accordingly no classification was applied to test substance.

Based on a read across approach, no classification for repeated dose toxicity was applied to Direct Blue 273.