DL-serine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 April 2003 - 23 April 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

DL-serine

EC Number:

206-130-6

EC Name:

DL-serine

Cas Number:

302-84-1

Molecular formula:

C3H7NO3

IUPAC Name:

DL-serine

Test material form:

other: powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 20017
- Expiration date of the lot/batch: 5 July 2003
- Purity: 98.5%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 3.09 to 3.32 kg
- Housing: Stainless steel cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet and a supplement of hay
- Water (e.g. ad libitum): drinking water was provided ad libitium
- Acclimation period: at least 48 days, soft white untreated wood blocks were given for environment enrichment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hour period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: reverse osmosis water

Controls:

yes, concurrent no treatment

yes, concurrent vehicle

yes, concurrent negative control

Amount / concentration applied:

0.5 g of test substance

Duration of treatment / exposure:

Three exposures (of three minutes, one or four hours duration)

Observation period:

Clinical signs: daily
Dermal responses: for 3 minutes or one hour exposures and approximately 1, 24, 48, 72 hours later.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Primary Irritation Index (PII)

Basis:

animal #1

Time point:

other: 4 hour exposure

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

other: Primary IRRItation Index (PII)

Basis:

animal #2

Time point:

other: 4 hour exposure

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: Primary Irritation Index (PII)

Basis:

animal #3

Time point:

other: 4 hour exposure

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Clinical signs: There was no signs of toxicity or ill health in any rabbit during the observation period.
Dermal responses:
three minute expose: no dermal reaction was observed throuthout the duration of the study.
one hour exposure: no dermal reaction was observed throuthout the duration of the study.
four hour exposure: no dermal reaction was observed throuthout the duration of the study.

Applicant's summary and conclusion

Interpretation of results:

other: non-irritant

Conclusions:

Under the conditions of this study, the test substance was classified as "non-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, EU Method B.4 and EPA OPPTS 870.2500 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.

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.