2,3-epoxypropyltrimethylammonium chloride

Endpoint summary

Description of key information

Acute oral: LD50 = 1088 mg/kg bw (Kr.2, EU RAR, 2008)
Acute dermal: LD50 = 1500 mg/kg bw (Kr. 2, EU RAR, 2008)
Acute inhalation: not conclusive (Kr. 2, EU RAR, 2008)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 088 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 500 mg/kg bw

Additional information

Acute oral:

In an acute oral study (Degussa, 1981a), considered as the Key study, five male and five female young adult, SPF-albino rats per dose and per sex were administered a single oral dose of 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) at volumes ranging from 4.0, 4.8, 5.8, 6.9 and 8.5 ml/kg in aqueous solution The 71.9% test substance in aqueous solution was diluted with water to 20% EPTAC (v/v). The original solution had about 10% impurities, apparently resulting from the synthesis. However, according to the information available, it can be considered that the study was performed similarly to the Guideline OECD No. 401.

 

The rats were observed for signs of toxicity for 14 days after which an autopsy was conducted on the survived animals. Within few hours of dosing, the rats showed sedation, dark-coloured eyes, tremors and convulsions. Later, diarrhoea and loss of consciousness was observed. No details were given about the doses at which the non-lethal effects occurred. The surviving animals appeared to have recovered at the end of the observation period. When observed macroscopically, animals had no treatment-related alterations. Mortality was observed at all tested doses. The animals died between 1 and 48 hours. An LD₅₀value of 1.34 ml/kg (CI95 1.18 and 1.52) for the 71.9% test substance was calculated according to the method of Weil. This can be converted to approximate milligrams using the density value of 1129 mg/cm³available for 70% EPTAC. The

resulting LD₅₀is 1513 mg/kg of the 71.9% test substance or 1088 mg/kg pure EPTAC.

 

In another study (Shellengberger, 1962), considered as a supporting study, an LD₅₀value of 1720 mg/kg was obtained from an experiment where ten rats per dose group were administered orally 1250, 1575, 1988, 2500 mg/kg of EPTAC.

 

Considering the LD₅₀of 1088 mg/kg bw obtained for the pure substance, EPTAC is classified as Acute tox. 4 (H302, harmful if swallowed) according to the CLP regulation (No. 1272/2008 EC) and as harmful if swallowed (Xn, R22) according to the Directive 67/548/EEC.

Acute dermal:

In a dermal acute study(Shellengberger, 1962), two groups of three rabbits each were administered dermally either 1500 or 3000 mg/kg 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) in an aqueous solution. There was no information about the methodology used to expose the animals to the test substance (duration, type of patch).

 

In the lower dose group (i.e.1500 mg/kg bw) one rabbit died after 7 days of administration whereas in the higher dose group (i.e.3000 mg/kg bw), two rabbits died in 5 h or 2 days. The LD₅₀was estimated to be between 1500 – 3000 mg/kg bw.

 

Considering the lower limit of the range dermal LD₅₀(1500 mg/kg bw), EPTAC is classified as Acute tox. 4 (H312, harmful in contact with skin) according to the CLP regulation (No. 1272/2008 EC) and as harmful in contact with skin (Xn, R21) according to the Directive 67/548/EEC.

Acute inhalation:

According to a test performed by Dow (1984) a 7-hour inhalation exposure at a nominal concentration of 8.17 mg/L 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) caused no lethality or systemic effects in 4 female rats. The only observed effect was irritation to the eyes. No properly conducted test to obtain a 4-hr LC₅₀value is available. It can be hypothesized that the 4-hr LC₅₀value is above 5 mg/L, which is the limit classification for an acute inhalation of dust or mist. However, due to the study quality, no definite conclusion can be drawn for the acute toxicity via inhalation route.

Justification for classification or non-classification

Harmonised classification:

2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) is classified as Acute Tox. 4 (Harmful if swallowed, H302) and Acute Tox. 4 (Harmful in contact with skin, H302) in the Annex VI, Table 3.1 of the CLP regulation (No 1272/2008) and as Harmful if swallowed (Xn, R22) and Harmful in contact with skin (Xn, R21) in the Annex VI, Table 3.2 of the CLP regulation (1272/2008).

No additionnal self-classification is proposed