Registration Dossier
Registration Dossier
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EC number: 946-768-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
LD50 > 5000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No information on "acute oral toxicity" is available for the Target Substance. However data on Similar Substance 02 has been taken into account for the assessment. More details about the similarity between the two substances are reported in section 13.
An in-vivo study for acute toxicity by oral route has been carried out according to a guideline similar to OECD 401 (only two doses tested). Male and female rats were administered 5000 mg/kg bw of a mixture with 50 % of the dye. No mortality was observed and therefore the LD50 or LD0 was set equal to 5000 mg/kg bw.
A study on acute toxicity by intraperitoneal route was carried out on the same test substance. The LD50 calculated in this tes was between 700 and 2000 mg/kg bw.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity.
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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