Registration Dossier
Registration Dossier
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EC number: 827-162-2 | CAS number: 2218502-12-4
Endpoint summary
Administrative data
Description of key information
The acute toxicity of the substance CAS 2218502-12-4 (Direct Black 168 NaLi salts) has been determined by read-across from a structural analogue substance CAS 93281-13 -1 (Direct Black 168 Na salt). There are available adequate studies conducted with the source substance following oral administration in rats (OECD 401, GLP compliant) and dermal administration in rats (OECD 402, GLP compliant).
No studies are available for the determination of acute toxicity by inhalation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the report for the analogue approach in section 13 "Other reports"
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Reference
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
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the report for the analogue approach in section 13 "Other reports"
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Acute oral toxicity: Based on the results of acute oral toxicity testing conducted on the structural analogue, the substance is not classified as hazardous for the Acute Oral Category Hazard according to the EU CLP classification criteria (EU Regulation 1272/2008).The criteria in CLP Regulation establishes the limit for classification as Acute Tox Oral Category 4 in 2000 mg/kg, and the value obtained is >2000 mg/kg bw.
Acute dermal toxicity: Based on the results of acute dermal toxicity testing conducted on the structural analogue, the substance is not classified as hazardous for the Acute Dermal Category Hazard according to the EU CLP classification criteria (EU Regulation 1272/2008).
Acute inhalation toxicity: There isn't any test available for acute inhalation toxicity. The 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. No further information is necessary.
In conclusion, the substance is not classified for oral, nor dermal acute toxicity, according to the CLP Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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