L-4-hydroxyproline

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-03-24 to 1997-03-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

L-4-hydroxyproline

EC Number:

200-091-9

EC Name:

L-4-hydroxyproline

Cas Number:

51-35-4

Molecular formula:

C5H9NO3

IUPAC Name:

L-4-hydroxyproline

Test material form:

solid: crystalline

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: lot 96003:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble and stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: test item suspended at 50 % distilled water

FORM AS APPLIED IN THE TEST (if different from that of starting material): est item suspended at 50 % distilled water

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: ca. 3 months
- Weight at study initiation: ca. 2 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Lab Diet Certified Rabbit Diet #5322
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 °C
- Humidity (%): monitored
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 1997-02-27 To:1997-03-27

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 50 %

VEHICLE
- Purity: distilled water

Duration of treatment / exposure:

24 h

Observation period (in vivo):

24, 48, 72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 24 h

SCORING SYSTEM: Severity of ocular lesions

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: All 6 animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: Area of cornea involved

Basis:

other: All 6 animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness, chemosis, discharge

Basis:

other: All 6 animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not irrittaing to the eye.

Executive summary:

6 New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 mI of the test article in 1 eye. The contralateral eye, remaining untreated, served as a control. The eyes of all animals remained unwashed for 24 hours' Observations of corneal opacity, intis, and conjunctivitis were recorded 24, 48, and 72 hours after treatment. The test article was used as a 50 percent suspension in distilled water (test article and distilled water were added together in aratio of 1:1 2 grams of each).

The substance did not show any eye irritating properties under the conditions of the test.