Registration Dossier
Registration Dossier
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EC number: 257-048-2 | CAS number: 51200-87-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Skin corrosion: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 - 29 May 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- No observation after 72 hours
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Skin Corrosion Test in Rabbits to evaluate corrosive potential of a chemical or a product to the skin
- Short description of test conditions: The test material (0.5g or 0.5 ml) will be applied to a hair free area one the back. The test material will be left in contact with the skin for four hours. After exposure, the skin sites will be wiped clean and left exposed to the air for the duration of the study. The treated skin site will be visually examined for erythema, edema or any irreversible tissue destruction at 4, 24 and 48 hours after the initial application of the material. - GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4-dimethyloxazolidine
- EC Number:
- 257-048-2
- EC Name:
- 4,4-dimethyloxazolidine
- Cas Number:
- 51200-87-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4,4-dimethyl-1,3-oxazolidine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IMC, Terre Haute, Indiana / Lot 94
- Purity:
P-1952 - Lot 94
Oxidine (Oxazolidine A) 82.01 w/w %
TMO (Trimethyl oxazolidine) 2.90 w/w %
Water 15.00 w/w %
ox APD (Oxazolidine from 2-amino-1,3-propanediol) 0.01 w/w %
ox E (Oxazolidine E) 0.05 w/w %
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbit ranch, Gary, Indiana
- Age at study initiation: At least 9 weeks
- Weight at study initiation: 2.8 ± 0.2 kg
- Housing: Individually caged during and after exposure
- Diet: Purina Certified Rabbit Chow #5322 ad libitum. Each utilized lot was identified and dated. The diet was certified free of contaminants and the analysis was performed by the supplier.
- Water: Tap water will ad libitum. Every quarter the animals' drinking water was analyzed to ensure that the levels of contaminants are equal to or less than the recommended levels as per the Primary Drinking Water Regulations (40 CFR. 141.11, 141.12, 141.14).
- Acclimation period: at least 7 days
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: as supplied - Duration of treatment / exposure:
- 4 hours
- Observation period:
- - Skin examination: 4, 24 and 48 hours after application of the test material
- Body weights: At 0 and 48 hours after application - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 sq inch
- Type of wrap if used: covered with gauze and a "Dermicel" cloth tape. The animal trunk was then loosely wrapped with an impervious rubberized cloth and a flexible stainless steel protective screen held in place by tape.
REMOVAL OF TEST SUBSTANCE
The patches were removed and the treated skin sites were gently cleaned.
OBSERVATION TIME POINTS
- Skin examination: 4, 24 and 48 hours after application of the test material
- Body weights: At 0 and 48 hours after application
EVALUATION:
The sites were visually evaluated for erythema, edema and tissue destruction after stated time points.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.5
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.7
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.2
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The material applied easily on the skin. At 4, 24, and 48 hour observation period all the animals showed erythema and five animals showed edema. At 48 hours four animals still showed from mild to strong erythema, but none of the treated skin sites showed any tissue destruction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained in this in vivo Skin Corrosion Test of 4,4-dimethyloxazolidine (CAS 51200-87-4) showed erythema and edema after exposure to the substance, but no tissue destruction. The test item 4,4-dimethyloxazolidine (CAS 51200-87-4) is considered to be non-corrosive to skin.
- Executive summary:
The material applied easily on the skin. At 4, 24, and 48 hour observation period all the animals showed erythema and five animals showed edema. At 48 hours four animals still showed from mild to strong erythema, but none of the treated skin sites showed any tissue destruction.
Amine CS-1135 was noncorrosive to the skin and did not induce tissue damage.
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