Registration Dossier
Registration Dossier
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EC number: 931-275-3 | CAS number: 1125503-33-4
Endpoint summary
Administrative data
Description of key information
To assess the irritancy potential of Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) to the skin an acute dermal irritation/corrosion toxicity study was performed in the New Zealand White rabbit. Based on the resultsof this study the test substance is regarded as corrosive. In accordance with column 2 of Reach Regulation (EC) No 1907/2006 Annex VIII the in-vivo eye irritation study as well as the acute inhalation toxicity study (required in section 8.2.1 and 8.5, respectively) does not need to be conducted as the test substance is corrosive to the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
To assess the irritancy potential of Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) to the skin an acute dermal irritation/corrosion toxicity study was performed in the New Zealand White rabbit.
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema, extending beyond the treatment site, very slight or slight oedema. Additional dermal reactions noted 7 or 14 days after treatment included hard, light brown coloured scabs, hyperkeratinisation, dried blood, loss of skin elasticity, glossy skin and reduced fur re-growth. Scar tissue indicative of corrosion was also noted at one treated skin site on day 14.
An additional 3-minute semi-occluded application was performed on another group of three animals to assess the appropriate risk phrase. Very slight erythema was confined to two treated skin sites one hour after patch removal. No other adverse skin reactions were noted. The test material was regarded as corrosive according to EC labeling regulations.
As the test substance is corrosive to the skin it is assumed that the substance is also corrosive to the eye and no test was performed on animal welfare reasons.With regard to inhalation toxicity of the test item no animal study was performed. This is well-founded as inhalation is no endpoint of concern and since inhalation is no critical route of exposure and no peak exposures are to be expected.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) was found to be corrosive to rabbit skin according to EEC labelling regulations (Directive 67/548/EEC) and requires the symbol “C” and risk phrase R 34 „CAUSES BURNS”.
According to theRegulation (EC) No 1272/2008 of the European Parliament and of the Council, 16 December 2008 (CLP or GHS (Global Harmonized System for classification, labeling and packaging) Annex 1, Chapter 3.2.2.6.3 the test substance has to be classified: "Skin Corr. Cat 1C (exposition > 1 hour ≤ 4 hours; observation time ≤14 days), H314".
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.
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