Registration Dossier

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
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
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.