Registration Dossier
Registration Dossier
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EC number: 204-599-1 | CAS number: 123-08-0
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity
The LD50 value of the test item after oral administration was determined to be 3980 mg/kg bw (reference 7.2.1 -1).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension in vehicle
- Doses:
- 500, 2000 and 3980 mg/kg bw
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 3 980 mg/kg bw
- Based on:
- test mat.
- Mortality:
- at the dose of 3980 mg/kg bw 1/2 animals died.
- Clinical signs:
- 500 mg/kg bw: Animals became drowsy shortly after administration.
2000 mg/kg bw: Animals developed tremors shortly following administration.
3980 mg/kg bw: Animals developed tremors shortly following administration.
Some bilateral hydronephrosis was observed on doses of 500 mg/kg bw and greater. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 was 3980 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 980 mg/kg bw
- Quality of whole database:
- Data from handbook which is considered reliable to cover this endpoint
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
Acute oral toxicity
Based on the available data received from a publication, the LD50 of the test item is considered to 3980 mg/kg bw in rats after oral administration. Thus, the LD50 value is higher than the threshold of 2000 mg/kg bw leading to classification and labelling.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for fourteenth time in Regulation (EU) No 2020/217.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
