Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Acute Toxicity: Oral
-LD50 > 2000 mg/kg bodyweight in female rats
Acute Toxicity: DErmal
- Study not required according to Annex VII standard information requirement for substances manufactured or imported in quantities of one tonne or more if the oral LD50 is > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The key study was conducted under GLP conditions in accordance with the standardised OECD guideline 423 and EU Method B.1 tris. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997)
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
The test substance was administred by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15)
No mortality occured. CLinical signs of toxicity including hunched posture, piloerection and/or ptosis were noted for all animals on Days 1 and/or 2. The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bodyweight
Justification for classification or non-classification
Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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.
