Registration Dossier
Registration Dossier
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EC number: 700-661-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In accordance with Column 2, Annex VIII Section 8.5 of Regulation (EC) No 1907/2006, it is considered justified to omit studies on acute toxicity as the substance is classified as corrosive to the skin.
Key value for chemical safety assessment
Acute toxicity: via oral route
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
Oral
Acute toxicity testing by the oral route is waived as the substance is corrosive. Supporting information is available in the form of a range finding study that was conducted prior to the 28 -day repeated dose toxicity test. The study was conducted to GLP and was in accordance with the standardised guideline OECD 423. As the test material was not dosed at the top dose level of 2000 mg/kg, the EU criteria for classification could not be applied. The study was thereby assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).
During the study the test material was administered to three groups of female rats, by oral gavage, at concentrations of 50 and 300 mg/kg. Mortality, clinical signs and body weight were recorded and a gross necropsy was performed on all animals. Under the conditions of the study there were no unscheduled deaths. Clinical signs were restricted to hunched posture, which was recorded in one animals that received 300 mg/kg. This sign was observed at approximately 1 hour and approximately 1¾ hours after administration of the second dose fraction. No other adverse signs were recorded. Body weight gains were considered to be acceptable for rats of this age and strain and no macroscopic abnormalities were recorded in any animal. The LD50 of the test material was subsequently determined to be in excess of 300 mg/kg.
Inhalation
In accordance with Column 2, Annex VIII Section 8.5 of Regulation (EC) No 1907/2006, it is considered justified to omit studies on acute toxicity as the substance is classified as corrosive to the skin.
Dermal
In accordance with Column 2, Annex VIII Section 8.5 of Regulation (EC) No 1907/2006, it is considered justified to omit studies on acute toxicity as the substance is classified as corrosive to the skin.
Justification for classification or non-classification
The criteria for classification according to Annex I, Regulation 1272/2008 could not be applied because no relevant study on PSOA was available.
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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