ethyl N-acetyl-3,5-dinitro-L-tyrosinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester

Cas Number:

29358-99-4

Molecular formula:

C13H15N3O8

IUPAC Name:

L-Tyrosine, N-acetyl-3,5-dinitro-, etyhl ester

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The starting dose can be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information indicated that the test item was likely to be non-toxic regarding acute toxicity therefore we chose a dose of 2000 mg of L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester per kg body weight to be used as a starting dose. In the first step, one group of 3 females was dosed. The test item in limit dose did not cause mortality for 48 hours and therefore, in a second step, another 3 females were treated at the same dose level.

Clinical signs:

No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period at limit dose of 2000 mg/kg body weight was observed. Slight lethargy 30 minutes after administration of test item was seen in Animal No 3, but other adverse reactions during next 24 hours and 14-days observation period were not reported. Summary results of clinical observations are presented in Table 1.

Body weight:

The body weights of all animals increased during the study.

Gross pathology:

All animals were necropsied. No visible pathological findings were observed in animals dosed with 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The purpose of the study was to evaluate the potential toxic effect of the test item “L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester” when administered as a single oral dose to Wistar rats.
The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used.
A limit dose of 2000 mg/kg body weight was used as a starting dose. Available information indicated that the test item is likely to be non-toxic regarding acute toxicity, therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose.
In the first step, one group of 3 females was dosed. The test item at this dose did not cause death in the next 48 hours and therefore another 3 females were treated at the same dose level. The test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. Slight lethargy was observed in Animal No 3 ½ an hour after administration, but was not seen after 1 hour and later. During necropsy we did not observe any macroscopic findings in all Animals at this dose level. The LD50 of the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
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 L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is classified in GHS Category 5 – Unclassified. Limit test with dose of 5000 mg/kg body weight was not conducted.

Executive summary:

The test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester administered to 6 females Wistar rats at a limit dose of 2000 mg/kg did not induce signs of intoxication, change of health, nor any other adverse reactions during 14-days observation period. Slight lethargy was observed in Animal No 3 ½ an hour after administration, but was not seen after 1 hour and later. During necropsy no macroscopic findings were observed in all Animals at this dose level. The body weights of all animals increased in normal range during the study.

The LD₅₀ of the test item L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.

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 L-Tyrosine, N-acetyl-3,5-dinitro-ethyl ester is classified in GHS Category 5- Unclassified. Limit test with dose of 5000 mg/kg was not conducted.