Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-24 to 1998-03-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GL study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

EC Number:

500-500-3

EC Name:

Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts

Cas Number:

161074-67-5

Molecular formula:

Not applicable

IUPAC Name:

Acylation product between lauroyl chloride and amino acids

Test material form:

other: liquid

Details on test material:

• Identification, reference: PROTEOL OAT - Batch 97 255 001
• Appearance : yellowish liquid
• Purity:28,7% dry matter
• Quantity received, packaging : 250 ml, plastic bottle
• Date ofreceipt : February 09, 1998
• Analytical sheet : reported in appendix
• Storage : at room temperature, away from the light

Specific details on test material used for the study:

• Identification, reference: PROTEOL OAT - Batch 97 255 001
• Appearance : yellowish liquid
• Purity:28,7% dry matter
• Quantity received, packaging : 250 ml, plastic bottle
• Date ofreceipt : February 09, 1998
• Analytical sheet : reported in appendix
• Storage : at room temperature, away from the light

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Species, strain, supplier : Albino Rat, Sprague Dawley 0M, IFFA-CREDO (69210 - L’ARBRESLE, FRANCE).
Reason for species selection : the Rat is the animal chosen by the regulatory authorities to evaluate the safety of drugs and chemicals
- Number and sex: 10 animals: 5 males and 5 females
- Age, weight : about 6 weeks, weight between 189 g and 208 g (males) and 172 g and 187 g (females) at the beginning of the study.
- Acclimatization : at least 5 days
- Housing, diet: 5 animals by sex in polypropylene cages (310 x 465 x 190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360 - EPINAY SUR ORGE, FRANCE).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Animais have been fasted prior to substance administration by withholding food overnight.
They received by gavage, according to the bodyweight, the product diluted with distilled water (Meram batch 62421) at the single dose of 2000 mg/kg under a constant volume of 5 ml/kg.
The administered preparation was kept up under magnetic stirring during the treatments.

Doses:

2000 mg / kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observations
The animals were observed daily for 14 days after the treatment.
Clinical observations:
-A clinical observation was carried out at least once a day in order to evaluate the general appearance , the behaviour and vegetative functions of the animals. An individual clinical observation was realized one hour after treatment. The continuous observations during the five following hours were renewed each following day.
-Body weights were taken just prior to the test material administration (D1) and again on days 4,8 and 15.
-Macroscopic examinations:
.At the termination of the 14 observation days, the rats were sacrified after barbituric anaesthesia, then autopsied. All abnormalities were recorded.

Statistics:

no statistic

Results and discussion

Preliminary study:

No preliminary study

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No modification in the aspect, behaviour or vegetative functions was observed in the animals, 1 hour after the treatment or during the 5 following hours, excepted a slight piloerection visible during the first hour following the ingestion of the product.

Gross pathology:

The gross necropsy of the animaIs 14 days after the treatment did not show any visible organic or tissular lesions leading us to suspect a possible systemic toxicity ofthe product.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions adopted, the oral LD0 of the test material PROTEOL OAT - Batch 97 255 001 in male and female Rat is higher than 2000 mg/kg.
According to the 67/548/EEC directive, the test preparation is unclassified if swallowed

Executive summary:

the single oral administration of the preparation PROTEOL OAT-Batch 97 255 001 in the male and female Rat at the dose of 2000 mg/kg:

- Did not induce any death

- Had no significant toxic effect on the animals' behaviour or vegetative functions,

- Did not modify their weight growth,

- Did not cause any gross lesion visible at autopsy.

Under the experimental conditions adopted, oral LD50 of the test preparation is higher than 2000 mg/kg in the rat.

According to the 67/548/EEC directive, the test preparation is unclassified if swallowed