Protein hydrolyzates, rice bran

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Protein hydrolyzates, rice bran

EC Number:

305-224-5

EC Name:

Protein hydrolyzates, rice bran

Cas Number:

94350-05-7

IUPAC Name:

Protein hydrolyzates of Oryza Sativa

Test material form:

liquid

Details on test material:

yellow liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: DEPRE or IFFA CREDO
weight: about 250 g at the time of the trial
Acclimatation: at least 7 days in the animal selter of the laboratory were the trial is carried out
Housing: the animal are kept in individual polystyrene cages of standardized dimensions with perforated floor. These cages are places in a temperature controlled animal shelter where the temperature is 22°C+-3°C and the relative humidity is maintained between 30 and 75%
the air is filtered and evacuated.
Food: aliment A04, UAR - VILLEMOISSON - 91360 EPINAY SUR ORGE
Water: tap water provided ad libitum in sterilizable makrolon bottles equiped with stainless steel pipettes.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test item was administrated with the syringe and the gastro-esophageal probe at the chosen dose of 2 g/kg body weight, according to study report.

Doses:

2 g/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

The animals were observed regularly on the day of administration (immediately, within 15 minutes after gavage and 6h after administration) and then at least once a day for 14 days.
The various parameters observed were: Apathy, Excitation, Palpebral ptosis, sleeping, comas, tembling, convulsions, refusal of food or drink, modification of volume or appearance of feces or urines, mouth, anal ou nasal bleeding and mortality.
Animals were weighed on D0, D7 and D14.

Statistics:

none

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not classifÌed based on a LD50 higher than 2000 mg/kg bw and no toxic effects observed at that dose level.

Executive summary:

The test item was administered to a group of 5 males and 5 females Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 401.

No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.