L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester

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:

ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate

Cas Number:

440667-78-7

Molecular formula:

C20H25N3O5

IUPAC Name:

ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate

Test material form:

solid: particulate/powder

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

Mortality:

All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight. 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.

Clinical signs:

other: 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 Anim

Gross pathology:

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

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-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. 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.

CONCLUSION
The LD50 of the test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-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.