L-methionine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Study was originally judged Klimisch 1. However, according to the "Practical guide 6: How to report read-across and categories" the maximum score for read-across is 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

DL-methionine

EC Number:

200-432-1

EC Name:

DL-methionine

Cas Number:

59-51-8

Molecular formula:

C5H11NO2S

IUPAC Name:

methionine

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 3.5 months
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal served as control

Amount / concentration applied:

100 mg of the test substance was administered per eye. The test substance was ground to fine dust before application.

Duration of treatment / exposure:

Single exposure, no washing

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower Iid away from the eyeball. The Iids were then gently held together for about one second in order to prevent lass of the material.
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eyereactions were observed and registered. 24 hours after administration the eyes were treated additionally with fluorescein and examined.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 1-3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

There were no systemic intolerance reactions.

Other effects:

Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the present test conditions a single application of 100 mg D,L-Methionine per animal into the conjunctival sac of the right eye of three
rabbits caused the following effects:
Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation. The cornea and iris were not affected by instillation of the test compound. There were no systemic intolerance reactions.