Trimethyloctadecylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Based on the results from the in vivo irritation study, C18 TMAC is considered to be corrosive to skin as well as eyes.

Endpoint conclusion:

adverse effect observed (corrosive)

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

Skin

A study was conducted to determine the skin irritation / corrosion of the test substance, C18 TMAC (79.8% active) according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. A paste containing 0.5 g of the test substance (purity of 79.8%) with 0.3 mL isotonic saline was applied under semi-occlusive patches to the clipped dorsal area of four rabbits. One animal was exposed for 4 h and three animals were exposed for 3 min. The test sites were examined for evidence of primary irritation and scored according to Draize method. No signs of irritation were observed during the whole observation period after exposure to 3 min. However, a 4 h exposure resulted in slight to well defined erythema and a slight oedema, visible 30-60 min up to 22 days after removal of the plaster. Between one and seven days after application, slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured. Twenty-two days after application, pink coloured new skin and a scar was noted. Under the study conditions, the test substance was found to be corrosive to rabbit skin (Kreiling, 1996).

Eye

In accordance with Annex VII, Section 8.2, Column 2, eye irritation studydoes not need to be conducted because the substance is classified as corrosive to the skin.

Based on the results of thein vivoskin irritation study, the test substance warrants a corrosive, ‘Skin Corr. 1C; H314: Causes severe skin burns and eye damage’ as well as serious eye damage, ‘Eye dam. 1; H31: Causes serious eye damage’ classification according to the EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects. 

With regard to respiratory tract irritation, although C18 TMAC is a very corrosive substance, its low vapour pressure prohibits the occurrence of respiratory irritation by vapour. Further, the classification of corrosive is already considered to implicitly cover the potential of RTI; therefore, an additional Cat.3 is considered to be superfluous (Guidance CLP Ch. 3.8.2.5).