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

Endpoint summary

Description of key information

In an acute oral toxicity study with rats according to OECD 423, the LD50 value of the read-across substance exceeded 2000 mg/kg bw (reference 7.2.1-1).

In an acute dermal toxicity study with rats according to OECD 402, the LD50 value of the read-across substance exceeded 2000 mg/kg bw (reference 7.2.3-1).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

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

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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

Species:

rat

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

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 acute 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 acute oral and dermal toxicity potential of the test item.

 

Acute oral toxicity

The GLP study was performed according to OECD TG 423. The read-across substance was tested for acute toxicity in Wistar rats (3/sex/dose) after oral administration of a limit dose of 2000 mg/kg body weight was applied. Directly before the administration the test material was prepared with aqua pro injectione as vehicle. The animals were observed for 14 days. All rats survived the observation period. No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw. The body weight development was normal. Gross pathology showed no alterations. According to the results of this study the read-across substance is not acute toxic, i.e. the LD50 value is expected to exceed 2000 mg/kg bw.

 

Acute dermal toxicity

The acute dermal toxicity of the read-across substance was evaluated in rats according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females). The application was performed with the test item in its original form at the dose of 2000 mg/kg bw. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy. The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations). No clinical signs and no deaths were observed during the study. A reduced weight gain was seen in all males and in 3/5 females between day 1 and day 8. The body weight gain of the other females was similar to historical control animals. No cutaneous reactions were observed. No apparent abnormalities were observed at necropsy in any animal. Under the experimental conditions, the dermal LD50 of the read-across substance is higher than 2000 mg/kg bw in 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 acute toxicity, the test item does not require classification for acute toxicity via the oral or dermal route according to Regulation (EC) No 1272/2008 (CLP), as amended for seventeenth time in Regulation (EU) No 2021/849.