L-methionine

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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 material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 5 months
- Sex: male animals
- Weight at study initiation: 2.4- 2.9 kg
- Fasting period before study: -
- Housing: singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 adaptation days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control site at the same animal

Amount / concentration applied:

A dose of 500 mg was applied to the test site (area: approx. 6 cm2). Pulverised solids were moistened sufficiently with water to ensure good contact with the skin.

Duration of treatment / exposure:

Exposure time was four hours. During the exposur the animals were kept in comfortable restrainers.

Observation period:

Scores were taken 60 minutes, 24, 48 and 72 hours after patch removaL

Number of animals:

3 Male animals

Details on study design:

- Area of exposure: aprox. 6cm2
- Type of wrap if used: covered with a gauze patch (non-irritating tape)

REMOVAL OF TEST SUBSTANCE
- Washing: No residual test substance had to be removed.
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1-3

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

anmal 1-3

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg D,L-Methionine/patch and animal (semi-occlusive condition) showed any substance-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions .