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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50, oral, rat, m/f > 2000 mg/kg bw

LD50, dermal, rat, m/f > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Vehicle:
polyethylene glycol
Remarks:
600
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: full details are not available
Mortality:
Male at 2000 mg/kg bw, number of deaths: 0
Female at 2000 mg/kg bw, number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: diarrhoea, apathie, piloerection
Gross pathology:
Effects on organ: none
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
migrated 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 study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw, number of deaths: 0
Female: 2000 mg/kg bw, number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: normal general state, retarded fur growth
Gross pathology:
Effects on organs: none
Other findings:
Discolouration of the skin due to the dye
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The analogue substance was tested for acute oral and dermal toxicity in two in-vivo studies following EU Method B1 and B3 respectively in a limite test. No mortality was observed for both studies nor effects on organs analysed by gross pathology. No other adverse effects were observed. The substace showed LD50 (LD0) > 2000 mg/kg bw and can be defined as non toxic.

Based on the read across considerations the same applies to Direct Blue 299

Justification for classification or non-classification