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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 10, 2000 - April 28, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Minor deviations in humidity were observed during the study period but these deviations did not affect the integrity of the study.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
EC method B4
Deviations:
yes
Remarks:
humidity
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
humidity
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
humidity
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Threonineethylester
- Analytical purity: 97%
- Purity test date: no data
- Lot/batch No.: 142-576-6
- Expiration date of the lot/batch: no data
- Stability under test conditions: Considered to be stable when used under testing
- Storage condition of test material: frozen
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 142-576-6


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: < 10 °C when not in use


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: 50% m/v dispersion

OTHER SPECIFICS
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is added: pH of 9.16

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:NZW/Kbl.BR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate
- Age at study initiation: 11 to 13 weeks old
- Weight at study initiation: 2.03 to 2,37 kg
- Housing: floor-pens, single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22 °C
- Humidity (%): 40 to 80% RH (on the first eleven days of the study, humidity fell below range by up to 15% RH)
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours with fluorescent strip-lights

IN-LIFE DATES: From 4 April 2000 To 28 April 2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
moistening with approx. 0.1 mL of water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg

VEHICLE
- Amount(s) applied (volume or weight with unit): moistening with approx. 0.1 mL of water
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3 animals (1 male, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 30 x 20 mm
- % coverage: No data
- Type of wrap if used: semi-occlusive gauze patch and an open weave, elasticated adhesive bandage wrapped firmly around the torso

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lightly brushed clean of any solid residues and swabbed with moist cotton wool
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and eschar (Grade):
- No erythema (0)
- Very slight erythema (1)
- Well-defined erythema (2)
- Moderate erythema (3)
- Severe erythema (beet redness) or eschar preventing reading of erythema (4)

Oedema (Grade):
- No oedema (0)
- Very slight oedema (barely perceptible) (1)
- Slight oedema (edges of area well-defined by definite raising) (2)
- Moderate oedema (edges raised approximately 1 mm) (3)
- Severe oedema (raised >1 mm and extending beyond area of exposure) (4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
No dermal response to treatment or signs of toxicity or ill health were observed in any animal throughout the observation period
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation/corrosion of L-TEE was evaluated using a single semi-occluded application to intact rabbit skin for four hours. The study was perforned in compliance with the testing guidelines OECD (404) and EC (method B4). L-TEE did not elicit any dermal reactions. Based on these data, L-TEE is not classified.
Executive summary:

This study was conducted to determine the irritation or corrosion caused to intact rabbit skin. L-TEE (500 mg) was applied to a 30 x 20 mm area on the clipped dorsum of each of three New Zealand White rabbits on Day 1. The treated area of skin was covered by a semi-occlusive bandage for four hours. Dermal reactions to treatment were assessed for three days after removal of the dressings.

No reactions were observed following a single semi-occluded, topical application of L-TEE to the intact skin of three rabbits for four hours.

Based on these data, L-TEE is not classified.