Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Effects on developmental toxicity

Description of key information

The read-across source substance was found to have no adverse effect on the development of rats. The No Observed Effect Level (NOEL) for maternal toxicity and embryofetal development is 1000 mg/kg bw/day (reference 7.8.2 -1).

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The guideline study using the read-across substance is of high quality and reliable without restrictions.

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

No study data with the test item is available for developmental toxicity. Therefore, a read-across to the read-across source substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the teratogenic potential of the test item.

 

Developmental toxicity study

The objective of this prenatal developmental toxicity GLP-study according to OECD TG 414 was to evaluate the potential toxic effects of the read-across source substance on the pregnant and on embryonic and fetal development following daily oral administration (gavage) to pregnant female rats from implantation to the day prior to the scheduled hysterectomy (day 6 to day 19 post-coitum inclusive).

Four groups of 24 mated female Sprague-Dawley rats, received the test item by oral administration (gavage) at 100, 300 or 1000 mg/kg bw/day from day 6 to day 19 post-coitum. A group of 24 mated females was given the vehicle alone (purified water) under the same experimental conditions and acted as the control group. Clinical signs and mortality were checked daily. Body weight and food consumption were recorded at designated intervals. On day 20 post-coitum, the dams were sacrificed and subjected to macroscopic examination. The gravid uterus was weighed to allow calculation of the net body weight gain of females. The fetuses were removed by hysterectomy. The litter parameters were recorded, namely: number of corpora lutea, implantation sites, early and late resorptions, dead and live fetuses. The fetuses were weighed, sexed and submitted to external examination of the soft tissue and the other half to a detailed examination of the skeleton (bone and cartilage).

There was no mortality in any group.There were no treatment-related clinical signs in any group. The food consumption and body weight were unaffected by the treatment with the test item. No macroscopic findings that were related to the treatment were noted at any dose-level. No treatment-related effect was noted on litter data parameters, namely: corpora lutea, implantation sites, post-implantation loss, number of live fetuses and fetal body weight. No fetal external, soft tissue or skeletal variations or malformations were observed that were considered to be attributable to the treatment with the test item.

In conclusion, the test item, when administered to pregnant female rats from day 6 to day 19 post-coitum was well tolerated at all dose-levels. No effect on litter data parameters and fetal development were observed.

In conclusion, 1000 mg/kg bw/day is the No Observed Effect Level (NOEL) for maternal toxicity and embryofetal development.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on developmental toxicity, the test item does not need to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.