2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)-1,3-propanediol hydrochloride

Endpoint summary

Description of key information

In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the read-across substance was determined as > 2000 mg/kg bw (reference 7.2.1 -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:

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 available study 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

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

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

A study according to OECD 423 was conducted to determine the acute oral toxicity of the read-across substance in rats. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out after termination of the observation period. All female rats survived until the end of the 14-day observation period. No symptoms were observed throughout the 14-day post-treatment period at any animals. The body weight development was undisturbed in all animals. All organs of the animals treated with 2000 mg/kg bw proved to be free of gross pathological changes. As no animal died in the first and second treatment group at 2000 mg/kg bw the stopping criteria of Annex 2d of OECD Guideline No. 423 was met and no further treatment group was initiated. In conclusion, the LD50 of the read-across substance was considered to be above 2000 mg/kg body weight by oral route in the rat.

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 route according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.