3-phenyl-L-alanine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec. 1970 to 1971-09-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: An OECD or other international guideline for acute oral toxicity was not available at the the year of the study. The study is similiar to OECD 401.

Deviations:

not applicable

Principles of method if other than guideline:

Groups of ten rats (five males and five females) were administered 0, 10 and 16g/kg bw L-phenylalanine and observed during two weeks for mortality.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-phenyl-L-alanine

EC Number:

200-568-1

EC Name:

3-phenyl-L-alanine

Cas Number:

63-91-2

Molecular formula:

C9H11NO2

IUPAC Name:

phenylalanine

Test animals

Species:

rat

Strain:

other: CFY strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Carworth Europe, Alconbury, Huntingdon
- Weight at study initiation: 62 - 123 g
- Fasting period before study: 20 hours before dosing (and 4 hours after dosing)
- Housing: caged in groups according to sex and age

Administration / exposure

Route of administration:

other: Solution in water or as suspension in 1 % methyl cellulose and administered by gastric intubation.

Vehicle:

other: water or methyl cellulose plus water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30% solution in water or 30% suspension in 1% methyl cellulose

MAXIMUM DOSE VOLUME APPLIED:
Maximum dosage volume of 53.3 ml/kg bodyweight, equivalent to a maximum practical dose of 16g amino acid /kg bodyweight.
Dosage volumes in excess of 20 ml/kg were given in divided doses at two hourly intervals.

Doses:

0, 10 and 16 g/kg bw.
Rats dosed with the vehicle alone served as controls.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight/behaviour

Statistics:

Method of Litchfield J.T., Wilcoxon F (1949), J. Pharmac. exp. Ther. 96, 99

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 10 000 - <= 16 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Dose descriptor:

approximate LD50

Effect level:

ca. 16 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: median Iethal oral dose

Mortality:

Three female rats died; one dosed at 10g/kg and two dosed at 16g/kg bw. Death occurred within 46 hours of dosing and was preceded by coma. Autopsy of animals that died did not reveal any specific cause of death.

Clinical signs:

other: Lethargie behaviour was observed shortly after dosing. Recovery of survivors, as judged by external appearance and behaviour was apparently complete within 3 days.

Gross pathology:

Autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute oral toxicity study was performed with groups of 5 male and 5 female rats. The results indicate that the median lethal oral dose (LD 50) of L-phenylalanine is ca. 16g/kg bw.