Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 433-730-7 | CAS number: 23926-51-4 L-THREONINETHYLESTER
Skin irritation / corrosion
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:
- 2 000
- 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
- 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
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
