Registration Dossier
Registration Dossier
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EC number: 269-085-1 | CAS number: 68187-30-4
Endpoint summary
Administrative data
Description of key information
Skin:
The test material was not irritating to the skin of the New Zealand White rabbit.
Eye:
The test material was found to be irritating to the eye of the New Zealand White rabbit.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion". A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites. All treated skin sites appeared normal seven days after treatment. The test material produced a primary irritation index of 0.5. No corrosive effects were noted. Therefore the test material was regarded as non-irritant.
Eye:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion". A single instillation of the test material to the non-irrigated eye of three rabbits produced translucent or opalescent corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were circumcorneal vascularisation, convoluted eyelids and dulling of the normal lustre of the corneal surface. The test material was classified as irritant.
The studies were conducted with a structurally similar substance, namely the monosodium salt. Solubility, bioavailability and toxicity of the surrogate are not expected to differ from the registered substance as the counter ion is not known for a specific toxicity and sodium salts are generally known to be of high solubility.
Effects on eye irritation: irritating
Justification for classification or non-classification
No classification and labelling is required for skin irritation according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
Based on eye irritation data available, the test item is classified as eye irrit. cat. 2 (H319: Causes serious eye irritation) according to Regulation No (EC) 1272/2008 (CLP) and as Xi; R36 Irritant; Irritating to eyes according to Directive 67/548/EEC (DSD) criteria.
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