2,3-epoxypropyltrimethylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data was available.

Effect on fertility: via oral route

Dose descriptor:

NOAEL

10 mg/kg bw/day

Additional information

There are no studies conducted on toxicity to fertility. Some information of the effect on the morphology of the gonads can be obtained from the 28-day test conducted with Wistar rats. The rats were administered by oral gavage 0, 3.16, 10.0, 31.6 or 100 mg/kg EPTAC (72.6 %) for 28 days (Degussa, 1990). The control and high dose group had 10 males and 10 female and the low- and mid-dose groups had five rats of each sex. Five high dose and five control group animals were submitted to a 4-week post-exposure observation period. The study was conducted under GLP regulations and OECD guideline 407 was followed as the study protocol. See section 7.5.1 "3033 -77 -0 Repeated dose toxicity: oral/2008/EURA" for a more complete description of the study.

Male rats of the highest dose groups had a significant decrease (-35-40%) of the testis weight at week 5, which remained significantly lower in the recovery group at week 9. The female ovaries showed a weight decrease trend at week 5, where the weight difference was significant in the dose groups 31.6 mg/kg and 100 mg/kg. However, at week 9 in the recovery group, there was significant ovary weight decrease (max 60%) in the right ovary only in the 100 mg/kg dose group. Microscopically, males of the 31.6 and 100 mg/dose groups showed a dose-related incidence and severity of focal atrophy of the testes. Females had a dose dependent severity of follicular atrophy and persistent corpora lutea in the 31.6 and 100 mg/kg dose groups. The uterus epithelium was atrophic and morphologically in anoestrus. The changes in the gonads persisted in both sexes through the recovery period. The body weight in the 100 mg/kg group males at day 28 was about 45% lower than the control group and in the 31.6 mg/kg group at that time the mean body weight was about 18% lower and in the 10 mg/kg group a 12 % reduction was noted. The 100 mg/kg dose females had about 38 % lower mean body weight than the control. No significant difference was noted in other groups or in the recovery group. After the recovery period, the male 100 mg/kg recovery group had still about 29% lower mean body weight, when compared to control.

Although these results tell little of the effect on the reproductive performance itself they can be used to set an indicative NOAEL based on the rather severe morphological changes in the reproductive organs of both sexes. The 10 mg/kg NOAEL obtained from the 28-day repeated dose toxicity study is selected for toxicity to reproduction. EPTAC is therefore classified as Repr.2, H361f (Suspected of damaging fertility) according to the criteria of the CLP regulation (No 1272/2008) and as Repr. Cat. 3; R62 (Possible risk of impaired fertility) according to the criteria of Directive 67/548/EEC.

Short description of key information:
The 10 mg/kg NOAEL obtained from the 28-day repeated dose toxicity study is selected for toxicity to reproduction (OECD 407, Kr:2).

Effects on developmental toxicity

Description of key information

No data was available.

Additional information

No data was available

Toxicity to reproduction: other studies

Additional information

No data was available.

Justification for classification or non-classification

Harmonised classification:

EPATC is classified as Repr.2, H361f (Suspected of damaging fertility) in the Annex VI, Table 3.1 of the CLP regulation (No 1272/2008) and as Repr. Cat. 3; R62 (Possible risk of impaired fertility) in the Annex VI, Table 3.2 of the CLP regulation (1272/2008).

No additionnal self-classification is proposed

Developmental toxicity/teratogenicity:

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