D-serine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 January 2005 to 22 February 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

D-serine

EC Number:

206-229-4

EC Name:

D-serine

Cas Number:

312-84-5

Molecular formula:

C3H7NO3

IUPAC Name:

D-serine

Test material form:

solid

Details on test material:

- Appearance: white solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light
- Stability under storage conditions: stable under storage conditions

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 12 - 13 weeks old
- Weight at study initiation: 2.12 - 2.29 kg on the day of treatment
- Housing: animals were housed individually in stainless steel cages furnished with wood blocks and haystacks
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Air changes (per hr): ca 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: test material was moistened with 0.1 mL distilled water

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours following application of the test material

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: the left flank was clipped free of fur exposing an are of ca. 100 cm²
- Type of wrap if used: test material was covered with a gauze patch (ca 4 cm x 4 cm) which was itself covered with a semi-occlusive dressing. The dressing was wrapped around the animal and fastened with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 hours exposure the dressings were removed and the skin flushed with lukewarm tap water

OBSERVATION TIME POINTS
Observations for viability/mortality and clinical signs were made daily. Body weights were recorded on the day of application and at the end of the observation period.
Skin irritation was assessed at 1, 24, 48 and 72 hours after removal of the dresings and test material.

SCORING SYSTEM:
- Method of calculation: Draize score system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 24, 25, 26

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 24, 25, 26

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test material did not illicit any skin reactions at the application site of any animal at any of the observation times (all scores were 0).

Other effects:

- Viability, mortality and clinical signs: No clinical signs of systemic toxicity were observed and no mortality occurred.

- Body weights: the body weights of all animals were considered to be in the normal range of variability. All animals gained weight during the study.

Applicant's summary and conclusion

Interpretation of results:

other: the substance does not meet the criteria for classification as a skin irritant

Conclusions:

Under the conditions of the study, the substance does not meet the criteria for classification as a skin irritant.

Executive summary:

The skin irritation potential of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 404 and EU Method B.4 and under GLP conditions.

During the study the test material was applied by topical semiocclusive application of 0.5 g to the intact left flank of each of three New Zealand White rabbits. The duration of treatment was 4 hours. Skin reaction were assessed 1, 24, 48 and 72 hours following removal of the test material.

Under the conditions of the study, no clinical signs of systemic toxicity were observed and no mortality occurred. Body weights of all animals were considered to be in the normal range of variability. All animals gained weight during the study.

The test material did not illicit any skin reactions at the application site of any animal at any of the observation times (all scores were 0). The test material is therefore not considered to be a skin irritant.