2,3-epoxypropyltrimethylammonium chloride

Endpoint summary

Description of key information

Repeated dose toxicity, oral: LOAEL = 3.16 mg/kg bw/day based on  (OECD 407, GLP) based on the effects on the kidney proximal convoluted 
tubules (vacuolisation, necrosis, hyperplasia) already seen as minimal at 3.16 mg/kg but evident at 10 mg/kg in the kidney .
Repeated dose toxicity, inhalation: no data
Repeated dose toxicity, dermal: no data

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

LOAEL

3.16 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

Repeated dose toxicity: oral

One study was available, considered as valid (Kr:2) and was used for Harmonised classification (Degussa, 1990). The study was conducted under GLP regulations and OECD guideline 407 was followed as the study protocol. Wistar rats were administered by oral gavage 0, 3.16, 10.0, 31.6 or 100 mg/kg EPTAC (72.6 %) for 28 days. The control and high dose group had 10 males and 10 female whereas the low- and mid-dose groups had five rats of each sex. Five high and five control group animals also had a 4-week post-exposure observation period. 2,3 -epoxypropyltrimethylammonium chloride (EPTAC) is lethal to rats at a dose of 100 mg/kg bw/day. Reduced food consumption and decreased in body weight gain and slight effects in hematology parameters are considered to be treatment related. Microscopical examinations showed that the kidneys are the most sensitive target organ. Other treatment related changes were mainly observed in organs, that contain fastly dividing cell population (bone marrow, spleen, thymus, gonads, uterus, stomach, intestines. Abnormal mitosis were noted in some of these organs. The findings in stomach and small intestine were attributed to the locally irritant properties to EPATC.

Based on the effects on the kidney proximal convoluted tubules (vacuolisation, necrosis, hyperplasia) already seen as minimal at 3.16 mg/kg but evident at 10 mg/kg in the kidney a LOAEL of 3.16 mg/kg can be set.

EPTAC is therefore classified as STOT RE 2, H373 (May cause damage to organs through prolonged or repeated exposure ) according to criteria of the CLP regulation ((No. 1272/2008 EC), and as Harmful: danger of serious damage to health by prolonged exposure if swallowed, (Xn, R48/22) according to the criteria of Directive 67/548/EEC.

This sub-acute toxicity study in the rats isacceptableand satisfies the guideline requirement for a sub-acute oral study (OECD 407) in rats.

Repeated dose toxicity: inhalation

No data was available.

Repeated dose toxicity: dermal

No data was available.

Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification

Harmonised classification:

2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) is classified as:

STOT RE 2, H373 (May cause damage to organs through prolonged or repeated exposure ) in the CLP regulation ((No. 1272/2008 EC), Annex VI, Table 3.1) and as Harmful: danger of serious damage to health by prolonged exposure if swallowed, (Xn, R48/22) in the CLP regulation ((No. 1272/2008 EC), Annex VI, Table 3.2).

No additionnal self-classification is proposed

Repeated dose toxicity: dermal and inhalation routes

No-self classification is proposed due to lack of data.