Registration Dossier
Registration Dossier
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EC number: 212-825-5 | CAS number: 872-36-6
Endpoint summary
Administrative data
Description of key information
A reliable acute oral toxicity study in rats in available, performed according to OECD and EC guidelines and according to GLP principles.
A reliable acute dermal toxicity study in rats in available, performed according to OECD and EC guidelines and according to GLP principles.
A waiver for the absence of acute inhalation toxicity data is included.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
- Quality of whole database:
- good
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- good
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 200 mg/kg bw
- Quality of whole database:
- good
Additional information
A study was performed to assess the acute oral toxicity of VC following a single oral administration in the Sprague-Dawley CD (Crl:CD(SD)IGS BR) strain rat according to OECD 423. The test material was administered undiluted for the 2000 mg/kg dose level and as a solution in DMSO for the 200 mg/kg dose level. All females treated at dose level of 2000 mg/kg were found dead within 30 minutes. No deaths were noted at the dose level of 200 mg/kg. The LD50 was estimated within the range of 300 -500 mg/kg.
The dermal LD50 value of VC in Wistar rats was established to be within the range of 200-2000 mg/kg bw.
Based on the mortality at 2000 mg/kg bw and on the clinical signs at 200 and 2000 mg/kg bw, no animals were treated at 1000 mg/kg bw for ethical reasons. Therefore, as a worst case scenario and for labeling and classification purposes, the dermal LD50 value of VC in Wistar rats was considered to be within the range of 200-1000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
reliable study on acute oral toxicity
Justification for selection of acute toxicity – inhalation endpoint
waiver for not performing acute inhalation toxicity
Justification for classification or non-classification
The test material was classified as Harmful and the symbol Xn and risk phrase R22 ""Harmful if swallowed"" are required according to EU labelling regulations Commission Directive 93/21/EEC.
Based on the data available, VC needs to be classified as `Harmful if swallowed (cat 4, H302)` and `Toxic in contact with skin (cat 3, H311) according to the:
-Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2011),
-Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
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.
