Registration Dossier

Administrative data

Description of key information

Acute oral, rats, LD50 > 2000 mg/kg bw (also LD0)
Acute dermal, rats, LD50 > 2000 mg/kg bw (also LD0)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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 on analogue substance
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male, 2000 mg/kg bw, number of animals: 5, numebr of death: 0
Male, 5000 mg/kg bw, number of animals: 5, number of death:0
Female, 2000 mg/kg bw, number of animals: 5, number of death:0
Female, 5000 mg/kg bw, number of animals: 5, number of death:0
Clinical signs:
2000 mg/kg : sedation, dispnea, piloerection, hunched posture
5000 mg/kg : sedation, dispnea, piloerection, hunched posture, movement disorder, diarrhoea

the surviving rats recovered within 4 to 6 observation days
Gross pathology:
No pathological changes were revealed for the animals sacrificed at the end of the test
Lung: several dark-red foci, in part, black
Liver, stomach, intestine, kidneys, adrenalas, spleen: black
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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 on analogue substance
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Remarks:
PEG400
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 animals: 5, number of death: 0
Female, 2000 mg/kg bw, number of animals: 5, number of death: 0
Gross pathology:
no signs
Other findings:
The area of application was discoloured black. All the rats recovered by the end of the test
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Two in vivo studies on the analogue substance for acute toxicity by oral and dermal route are available.

No mortality was observed for both studies, while systemic availability of a black substance was observed in the different organs at the highest dose without pathological changes.

based on the read across considerations the same values for LD50 for acute toxicity can apply to Acid Black 233:1

Justification for classification or non-classification

Based on the results of acute oral and dermal toxicity, no classification for acute toxicity is warranted under Regulation 1272/2008