Registration Dossier

Administrative data

Description of key information

Irritation studies for the skin and eye are available with the test item applied in a 1% aqueous solution. The outcome does not lead to a classification. However, there is evidence of a skin and eye strong irritation/corrosion potential derived from other studies.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The irritating/corrosive potential of the substance was not observed in animal studies perfomed for the endpoints skin and eye irritation/corrosion. However, based on the outcome of studies performed for other toxicological endpoints, the strong irritating/corrosive potential of the substance became evident.

In the range finding experiments for the skin sensitization study the guinea pigs received a topical application of the test material at concentrations of 10, 25, 50 and 75% w/v in sterile water. Each animal received all four concentrations of the test material (four test sites per animal). After treatment, all four animals exhibited severe dermal reactions at some of the sites and clinical signs of toxicity. As a result of these observations, the animals were sacrificed in a moribund condition and 24 hour scores were not obtained.

The acute dermal toxicity of the substance in the rat was investigated in a study performed according to OECD TG 402. A limit test was carried out at 2000 mg/kg bw in both sexes. At 5 hours post application, animals were symptom free. However, 24 hours post application, 7 animals were found dead and 3 animals were in a moribund status and euthanized for animal welfare reason. Test item-related black diffuse discoloration of the skin (external examination) and red-black diffuse discoloration of the skin (internal examination) were observed at the sites of application.

Furthermore, the test item belongs to a class of substances that are classified as irritant or even corrosive to skin and/or eyes. Also the pH of the substance is high (pH >13).

Taking into account the overall data available for the substance it is concluded that it has a strongly irritating / corrosive potential to the skin and eye.



Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on a weight-of-evidence approach the test substance is classified for the endpoint in accordance to the CLP Regulation (EC) No 1272/2008 with skin corrosive category 1C.

Based on a weight-of-evidence approach the test substance is classified for the endpoint in accordance to the CLP Regulation (EC) No 1272/2008 with eye corrosion category 1.