Registration Dossier
Registration Dossier
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EC number: 267-747-4 | CAS number: 67914-85-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-02-05 to 2004-02-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study performed similar to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion); however, the test substance is not adequately characterized and limited information is provided on the test animals, testing methodology and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Inadequate documentation of test material, environmental conditions, animals, methods and results.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Inadequate documentation of test material, environmental conditions, animals, methods and results.
- Principles of method if other than guideline:
- Study was performed according to SPL Standard Test Method 540.09
- GLP compliance:
- not specified
Test material
- Reference substance name:
- cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol
- EC Number:
- 267-747-4
- EC Name:
- cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol
- Cas Number:
- 67914-85-6
- Molecular formula:
- C13H13Cl2N3O3
- IUPAC Name:
- (+-)-cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol
- Details on test material:
- - Name of test material (as cited in study report): T001207
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: not applicable
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: no data To: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours, with observations at 1, 24, 48, and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Draize System 0-8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- other: Non-irritant
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 179
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 181
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 182
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 179
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 181
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 182
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No evidence of erythema/eschar formation or oedema formation was noted at any time at any test site.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was found to be non-irritating to rabbit skin and is therefore considered to be not classified.
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