Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
other:
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
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.
Endpoint conclusion:
adverse effect observed (corrosive)
Endpoint conclusion:
no study available

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

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".

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion