Didecyldimethylammonium chloride

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

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Based on the results from thein vivoirritation studies, DDAC is considered to be corrosive to skin as well as eyes. 

Endpoint conclusion:

adverse effect observed (corrosive)

Endpoint conclusion:

adverse effect observed (irreversible damage)

Endpoint conclusion:

no study available

Skin irritation/corrosion

In an OECD Guideline 404 compliant study, 0.5 mL of test substance was applied under occlusive patches on the clipped dorsal area of a total of six New Zealand White rabbits per group. The animals were left for an exposure period of 3 min for three animals and 1 h for the other three animals. The residual test material was removed by gentle swabbing with cotton wool soaked in 3% (v/v) aqueous acetic acid followed by cotton wool soaked in distilled water. Approximately one h following removal of the patches, and 24, 48, 72 h and 7 and 14 days later, the test sites were examined for evidence of primary irritation and scored according to Draize (1959). In this study, no adverse skin reactions were noted at any treated skin site in the 3 min exposure group except slight erythema and oedema at the treated sites up to the 72 h observation period. However, after 1 h exposure, a light brown discoloration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites one h after the removal of the patches. Eschar had developed at all treated skin sites at the 24 h observation period and continued to be present at the 48 and 72 h and day seven observation. Blanching and moderate erythema were also noted at all the treated skin sites during this period. On Day 14, sunken eschar was noted at all the treated skin sites. Based on the study results, the test substance is considered to be corrosive to skin (Safepharm, 1987).  

In a further OECD Guideline and EU Method compliant study, under GLP conditions, dorsal hair was removed by clipping in 6 animals and the neat test substance was applied to the skin under a semi-occlusive bandage. The animals were divided into two groups according to the exposure period: 3 min and 4 h. After removal of the patches, the skin is observed for signs of irritation. In this study, the 4 h exposure produced severe erythema and severe edema up to the 72 h observation period and the skin appeared rough, dry, scabbed with discoloration. The 3 min exposure produced slight erythema, slight to severe oedema up to 7 days and at end of 14 day observation period, the skin appeared dry, rough and leather-like. The mean score for oedema and erythema was 4 up to the observation period of 72 h. Based on the study results, the test substance was found to be corrosive (Hoechst, 1991).  

Further, DDAC is anticipated to be severely damaging to human skin based on its corrosive nature. The maximum concentration that is likely not produce irritating effect on intact skin is 0.1%. Irritation becomes manifest at concentrations of 1% and higher (Cutler and Drobeck, 1970).    

 

Eye irritation

The test substance is classified as corrosive to skin. Hence, for animal welfare reasons, testing for eye irritation has not been conducted and DDAC is considered to cause severe eye damage.  

Further, the substance is expected to be severely damaging to eyes based on its corrosive nature. Concentrations as low as 0.1 to 0.5% are often irritating to conjunctivae and mucous membranes (Cutler and Drobeck, 1970).  

Studies conducted in rabbit demonstrate that the test substance is corrosive to skin and warrants classification as Skin Corr. 1B - H314 (Causes severe skin burns and eye damage) according to EU CLP (Regulation EC/1272/2008) criteria. Testing for eye irritation was not conducted since the substance is proposed for classification as corrosive; severe eye irritation responses along with irreversible eye damage are expected.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

The vapour pressure of the test substance was measured according to the isothermal thermo gravimetric effusion method of OECD Guideline 104, EU Method A.4 and US EPA OPPTS 830.7950 (Brekelmans, 2012).

Vapour pressure:

0.006 Pa

at the temperature of:

25 °C

- The vapour pressure was found to be <1.5 × 10-3 Pa (i.e. <1.1 × 10-5 mm Hg) at 20°C and <5.8 × 10-3 Pa (i.e. <4.3 × 10-5 mm Hg) at 25°C.

- Data presented in the DDAC assessment report for Product Type 8 conducted under Directive 98/8/EC (evaluating Competent Authority: Italy, June 2015, attached in Section 13 of the IUCLID dataset) reported an additional vapour pressure study with VP values of 5.9E-06, 1.1E-05 and 2.3E-04 at 20, 25 and 50ºC respectively (US ISC).

As a conservative approach, the relatively higher vapour pressure value <5.8 × 10-3 Pa at 25°C of the purified form of the registered substance has been considered further for hazard/risk assessment.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Didecyldimethylammonium chloride

EC Number:

230-525-2

EC Name:

Didecyldimethylammonium chloride

Cas Number:

7173-51-5

Molecular formula:

C22H48N Cl

IUPAC Name:

didecyldimethylammonium chloride