3-acetylthiazolidine-4-carboxylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3-acetylthiazolidine-4-carboxylic acid

EC Number:

225-713-6

EC Name:

3-acetylthiazolidine-4-carboxylic acid

Cas Number:

5025-82-1

Molecular formula:

C6H9NO3S

IUPAC Name:

3-acetylthiazolidine-4-carboxylic acid

Test animals

Species:

rat

Sex:

female

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

olive oil

Doses:

The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

other: Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423

Mortality:

No mortality was observed during the study.

Clinical signs:

other: No observed signs

Gross pathology:

All test animals were subjected to gross necropsy and the results were recorded for each animal.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item 3-acetylthiazolidine-4-carboxylic acid is classified in Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.

Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item3-acetylthiazolidine-4-carboxylic acidwhen administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class(ATC)method was used.

Alimit dose of 2000 mg/kg body weight was used as a starting dose.Two groups of 3 females was dosed. All 6 females survived the limit dose.The limit dose of 2000 mg/kg body weight did not cause death or evident signs of toxicity.The body weights of all animals increased during the study except 2 animals. Stagnation of the body weight in all animals except 1 animal was observed between the first and second week after administration. During necropsy, no macroscopic findings were observed.

The LD₅₀of the test item3-acetylthiazolidine-4-carboxylic acidis greater than 2000 mg/kg body weight after single oral administration to Wistar rats.