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

Endpoint summary

Description of key information

In an experimental short-term repeated dose toxicity study under GLP conditions according to OECD Test Guideline No. 407 with rats, the read-across source substance did not induce any adverse effects, the NOEL was 1000 mg/kg bw/d (reference 7.5.1-1).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to section 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Key result

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no effect observed

Key result

Critical effects observed:

no

Endpoint conclusion

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.

Additional information

No study data with the test item is available for repeated dose 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 short-term toxicity potential of the test item.

 

Oral Repeated Dose Toxicity (Subacute)

The objective of the conducted study was to evaluate the potential toxicity of the structural analogue following daily oral administration (gavage) to rats for 4 weeks (GLP-study according to OECD TG 407). Three treated groups of ten male and ten female Sprague-Dawley rats received the test item by gavage at the dose-levels of 100, 300 or 1000 mg/kg bw/day for 4 weeks. An additional group of ten males and ten females received the vehicle alone (purified water) under the same experimental conditions and acted as a control group. A constant dosage-volume of 5 mL/kg bw/day was used. The animals were checked daily for mortality and clinical signs. Body weight was recorded before allocation of animals into the study and once a week thereafter. Food consumption was recorded once a week. Haematology, blood biochemical investigations and urinalysis were performed at the end of the treatment period. On completion of the treatment period, the animals were killed and submitted to a full macroscopic post-mortem examination. Designated organs were weighed and selected tissue specimens were preserved. A microscopic examination was performed on designated tissues from animals of the control and high-dose groups.

No death occurred during the study. No treatment-related clinical signs were noted and no relevant differences from controls were observed in the body weight of the treated animals. The food consumption was unaffected and no overt signs of toxicity were observed in haematological, blood biochemical or urinalysis parameters. Organ weights were unaffected by treatment and no macroscopic or histopathological findings revealed a treatment-related effect.

Under the experimental conditions of the study, the No Observed Effect Level (NOEL) was established at 1000 mg/kg bw/day in Sprague-Dawley rats.

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 subacute repeated dose toxicity, the test item does not require classification according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.