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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 at 30 days

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

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

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

Leist (Leist, 1982) and Dystar (Dystar, 1979) studies, respectively at 28 and 30 days, don't report a limit dose for Direct Red 23 (DR23), but identify No-Observed-Adverse-Effect-Level (NOAEL) as > 1000 mg/kg. In the other Dystar study it has been concluded that the no toxic effect level (NOEL) of DR23, when fed to rats for 6 months, was 750 ppm in the diet, or 37.5 mg/kg body weight/day; nevertheless in the same study has been stressed that the effects found at the 1500 and 3000 ppm levels were only weak, aspecific and of doubtful, if any biological significance.

Leist (Leist ,1982) and Dystar (Dystar, 1979) studies are more reliable than the Dystar supporting study, thus the key value chose was the NOAEL > 1000 mg/kg.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Subacute study (30 days) on Direct Red 23 of which results have been confirmed in the Leist et al. 1982 study.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin

Justification for classification or non-classification

According to CLP regulation (EC1272/2008) Direct Red 23 is not classified for repeated dose toxicity (subacute).