Registration Dossier
Registration Dossier
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EC number: 202-977-0 | CAS number: 101-80-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November , 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Non-GLP. Conducted to a recognised methodology; however lack of full assessment data and age of report results in deficient study. Therefore it is considered that this data can be utilised in conjunction with other skin data as a weight of evidence approach, on animal welfare grounds. This study is proposed as the key study, as the results are conducted on the substance alone to a recognised test method.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Department of Transportation, Hazardous Materials Regulations Board, Docket No. HM-57, Federal Register, Vol. 33, No. 28, Section 173.240, February 12, 1973.
- Deviations:
- no
- Principles of method if other than guideline:
- Skin corrosion assessment in 6 test subjects (rabbit)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4,4'-oxydianiline
- EC Number:
- 202-977-0
- EC Name:
- 4,4'-oxydianiline
- Cas Number:
- 101-80-4
- Molecular formula:
- C12H12N2O
- IUPAC Name:
- 4,4'-oxydianiline
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): 4,4'-oxydianiline, technical
- Lot/batch No.: 99-T
- Analytical purity: 99.88%
- Substance type: Solid
- Physical state: Solid
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Impurities (identity and concentrations): Not specified.
- Composition of test material, percentage of components: detailed as 99.88% purity
- Isomers composition: N/A
- Purity test date: Not specified
- Expiration date of the lot/batch: Not specified
- Radiochemical purity (if radiolabelling): N/A
- Specific activity (if radiolabelling): N/A
- Locations of the label (if radiolabelling): N/A
- Expiration date of radiochemical substance (if radiolabelling): N/A
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified
Constituent 1
- Specific details on test material used for the study:
- 4,4'-oxydianiline
4,4'-diaminodiphenyl ether
CAS 101-80-4
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not specified.
- Age at study initiation: Not specified.
- Weight at study initiation: 2 to 3 kg
- Housing: Not specified.
- Diet (e.g. ad libitum): Not specified.
- Water (e.g. ad libitum): Not specified.
- Acclimation period Not specified.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light):Not specified.
IN-LIFE DATES: Not specified.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): Not applicable
VEHICLE: None - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 48 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Not specified
- % coverage: Not specified
- Type of wrap if used: 1.5 by 1.5 inch, 12-ply cotton gauze pads and the trunk of each rabbit was then loosely wrapped with rubber sheeting
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, unspecified but assumed to be water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Visual
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 to 6
- Time point:
- other: mean score for 24 and 48h.
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score from the six animals at 24 and 48h. No results available at 72h. No individual data available.
- Irritation parameter:
- edema score
- Basis:
- animal: 1 to 6
- Time point:
- other: mean score for 24 and 48h.
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Mean score from the six animals at 24 and48h. No results available at 72h. No individual data available.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No effect observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- other: No effects observed
- Irritation parameter:
- edema score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- The test animals displayed no effects as a result of the treatment
- Other effects:
- None
Any other information on results incl. tables
No erythema or edema was observed at 4, 24, or 48 hours. Skin corrosion was not observed in any of the animals tested.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No effects were displayed in any of the 6 test animals used, hence it is concluded that the test material is not corrosive to rabbit skin.
- Executive summary:
No erythema or edema was observed at 4, 24, or 48 hours. Skin corrosion was not observed in any of the animals. According to the regulations of the Department of Transportation, 4,4’-oxydianiline was not considered a corrosive material.
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