Registration Dossier
Registration Dossier
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EC number: 202-635-0 | CAS number: 98-08-8
Endpoint summary
Administrative data
Description of key information
The LD50 in female and male rats administered intraperitoneally were determined to be 15000 and 23000 mg/kg bw, respectively. The LD50 respectively for mice was determined to be 10000 mg/kg bw (reference 7.2.4-1 +2).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 toxicity - rat
In a published study, the test item was applied intraperitoneally to the stomach of male and female rats in pure form and all treated animals were observed for 14 days after the administration. The LD50 was determined to be 15000 and 23000 mg/kg bw for females and males, respectively.
Acute toxicity - mouse
In a published study, the test item was applied intraperitoneally to the stomach of mice in pure form and all treated animals were observed for 14 days after the administration. The LD50 was determined to be 10000 mg/kg bw.
Acute oral toxicity
In accordance with REACh Annex XI (1.1.2) and Article 25 (1), existing data on acute toxicity with the test item is used to cover the endpoint ‘Acute toxicity: oral’ in order to avoid unnecessary animal testing. Acute toxicity study using intraperitoneal administrations route as worst case of application is included in the dossier under endpoint 4.2.4 ‘Acute toxicity: other routes’. No adverse effects were observed in intraperitoneal studies below 2000 mg/kg bw which is the limit dose for acute oral tests.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No. 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008, as amended for the twelfth time in Regulation (EU) No. 2019/521.
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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