Histidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10/03/1983 - 28/03/1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in a toxicological institute under supervision of a veterinarian. Even though, no specific guideline was followe the test was performed similar to the OECD guideline 423.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Histidine

EC Number:

200-745-3

EC Name:

Histidine

Cas Number:

71-00-1

Molecular formula:

C6H9N3O2

IUPAC Name:

histidine

Constituent 2

Reference substance name:

Lot 21.1693.01.02

IUPAC Name:

Lot 21.1693.01.02

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

White colored powder 99.5% purity.

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
Winkelmann, Borchen
- Age at study initiation:
males: 48-51 days;
females: 59 days
- Weight at study initiation:
males: 0.127 - 0.139 kg
females: 0.128 - 0.134 kg
- Fasting period before study:
16 hours before start of the test
- Housing:

- Diet (e.g. ad libitum):
ad libitum
- Water (e.g. ad libitum):
ad libitum
- Acclimation period:
5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
21 +- 2
- Humidity (%):
55 +- 5
- Photoperiod (hrs dark / hrs light):
12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: tragacanth

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
238 mg/ml
- Amount of vehicle (if gavage):
21.5 ml/kg

Doses:

5110 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the observation period of 14 days.

Clinical signs:

other: no adverse clinical signs observed

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

L-Histidine does not show acute toxicity in rats at a concentration of 5110 mg/kg.

Executive summary:

In this study the acute toxicity of L-histidine was assessed in a similar way as in the OECD Guideline 423, in rats via gavage.

Five animals were dosed with a dose of 5110 mg/kg, whereafter they were observed for 14 days.

No mortality occured and no adverse clinical signs were observed.

Even though no NOAEL was determined in this study, the results indicate that there were no effects at a concentration of 5110 mg/kg.