Protein hydrolyzates, rice bran

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

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 / tissue source

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or tissues and environmental conditions:

Source: ESD - Romans 01400 Chatillon sur Chalaronne
Weight: about 2 to 2.5 kg at the time of trial
Acclimatation : At least 5 days in the animal shelter of the laboratoy
Housing: The animal are kept in individual metal cages of standardized dimensions with perforated floor. These cages are placed in a temperature controlled animal shelter where the temperature is between 18 and 22°C and the relative humidity is maintained between 30 and 80%.
Food: ref 112; UAR - 91360 EPINAY SUR ORGE
Water: tap water provided ad libitum with automatic pipettes

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

0.1 ml of the product is administrated with a syringe. The eyelids of the animals are kept shut for about 10 seconds in order to avoid product loss. The eyes are not rinsed.

Observation period (in vivo):

Before the trial, the ocular mucose of each rabbit is examined in order to eliminate any animal presenting lesions.
The rabbits are restrained on the day of the trial. The product is instilled and the animals are restrained for our hour until the first examination is carried out. The animals are then returned in their cages.
The following eyes examinations are carried out on immobilized rabbits every day until day 7.
The observations are completed on day 3 if the ocular lesions have disappeared.
The examination is made in the following order: conjunctiva, pupli, cornea.

Number of animals or in vitro replicates:

3 rabbits

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1h, 24h, 48h and 72 hours

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Remarks:

The laboratory could not observe any irritant injuries at any moment. For this reason, the study was stopped at D4.

Irritant / corrosive response data:

The test item does not provide any specific irritant lesions of ocular mucose in the experimental conditions employed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not provide any specific irritant lesions of ocular mucose in the experimental conditions employed.

Executive summary:

An in vivo study was performed on New Zealand albino rabbit according to OECD guidelines number 405 of February 24, 1987 and EEC guidelines 67/548.

The test item was intilled in the formix of the conjunctiva of 3 rabbits, by a 0.1 ml dosage. The eye was not rinsed.

In order to rate chemical product in accordance with EEC guidelines 67/548, a mean irritation index was calculated for each animal.

The test item does not provide any specific irritant lesions of ocular mucose in the experimental conditions employed.

In these conditions, the product is rated as Slightly irritant.