Registration Dossier
Registration Dossier
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EC number: 251-780-6 | CAS number: 33996-33-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-03-09 to 2001-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Oxaceprol
- EC Number:
- 251-780-6
- EC Name:
- Oxaceprol
- Cas Number:
- 33996-33-7
- Molecular formula:
- C7H11NO4
- IUPAC Name:
- 1-acetyl-4-hydroxy-L-proline
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / lot 000703
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: grounded to fine powder
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2001-05-18 or earlier To: 2001-05-28
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: distilled water - Duration of treatment / exposure:
- 1 h, 24 h, 48 h, 72 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Type of wrap if used: adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure:
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 3 min, 1 h, 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within:
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance Oxaceprol is not irritant or corrosive to the skin
- Executive summary:
The study according to OECD 404 was performed to assess the irritancy potential of Oxaceprol to the skin of the New Zealand White rabbit.
The test material procuded a primary irrittaion index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.
Oxaceprol did not meet the criteria for classification as irritnat or corrosive to the skin according to CLP.
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