Quaternary ammonium compounds, benzyl-C16-18-alkyldimethyl, chlorides

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

The vapour pressure of the test substance was determined using the gas saturation method, according to OECD 104 Guideline (Hermansson, 2010).

Vapour pressure:

0 Pa

at the temperature of:

25 °C

vapour pressure = 1.6E-4 Pa at 20°C

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Based on the results of the read across studies, the test substance 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:

Study 1: A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12-16 ADBAC (50% active in water) according to the method 'Transport of dangerous goods, special recommendations relating to Class 8, United Nations handbook, 1977'. In this experiment, 0.5 mL of a the undiluted read across substance (50% active) was applied under occlusive dressing to the skin of 1 rabbit for 3, 30, 60 min and 4 h. The skin was washed with water upon removal of the dressing. Observations were recorded at 24, 48 and 72 h. A confirmatory study was performed with 3 min or 1 h applications in 3 rabbits each. In the main study, no dermal reactions were observed at any of the 6 sites after 3 min application. Moderate erythema (mean score: 2.6) with slight oedema (mean score: 1.9) at 4 sites and areas of skin necrosis at the other 2 sites were observed following 1 h application (Primary irritation index PII: 3 min: 0; 60 min: 4.5). Under the conditions of the study, the read across substance solution was considered to be corrosive to rabbit skin (Liggit, 1982).

Study 2: A study was conducted to determine the skin irritation / corrosion potential of the read across substance, C12 -16 ADBAC (80% active), according to Federal Hazardous Substances Labeling Act. The experiment was performed in rabbits. The undiluted read across substance (80% active) was applied on intact and abraded skin sites using occlusive patches for an exposure period of 24 h. The skin was then observed for erythema and edema formation and the scoring was done according to the Draize, Woodland and Calvery scoring system at 24 and 72 h from the onset of exposure. Severe erythema and edema were observed in all the test animals at both the abraded and intact sites. The mean Primary Irritation Index (PII) of the read across substance was calculated to be 6.29 and the mean values of erythema and edema were 3.33 (intact skin site), 3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin site). Based on the results of the study, the read across substance is considered to be corrosive to rabbit skin (Wallace, 1975).

The biocides assessment reports available from RMS Italy on C12-16 ADBAC, published by the Italian authorities in June 2015, concluded that the test substance to be corrosive to the skin (ECHA biocides assessment report, 2015). Based on the results of the read acrossin vivoskin irritation studies and in line with the biocides assessment report, the test substance is considered to be corrosive to skin.  

Eye:

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

Based on the results of the read across in vivo skin irritation studies, the test substance warrants a corrosive, ‘Skin Corr. 1B; 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 C16-18 ADBAC 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).