Registration Dossier

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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

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:
No observed signs
Body weight:
The body weights of all animals increased during the study except animals No 1 and No 2. Stagnation of the body weight in all animals except animal No 6 was observed between the first and second week after administration. Summary results of body weights are presented in the table.
Sex Dose ID Body Weight (g) Body Weight Difference (g)
Initial Week 1 Week 2 Week 1 - Initial Week 2 - Initial Week 2 - Week 1
♀ 2000 mg/kg 1 210 210 210 0 0 0
2 200 200 200 0 0 0
3 210 220 220 10 10 0
4 180 200 200 20 20 0
5 180 190 190 10 10 0
6 190 210 220 20 30 10
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.