Registration Dossier
Registration Dossier
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EC number: 252-487-6 | CAS number: 35285-68-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug - Sept 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported guideline conform study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 4-ethoxycarbonylphenoxide
- EC Number:
- 252-487-6
- EC Name:
- Sodium 4-ethoxycarbonylphenoxide
- Cas Number:
- 35285-68-8
- Molecular formula:
- C9H10O3.Na
- IUPAC Name:
- sodium 4-ethoxycarbonylphenoxide
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NWZ
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Weight at study initiation: 3500 g
- Housing: Animals were housed individually
- Diet: ssniff K, ad libitum
- Water: tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated sites of the same animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g test substance, moistened with water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
reading time points: 1, 24, 48, 72 h and 7 d - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² on the back of the animal
- Type of wrap if used: The test substance was applied to a gauze patch, held in place by elastic tape that was permeable to air.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin sites were washed with water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: mean of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- other: mean of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritant / corrosive response data:
- Dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, when evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin, was found to be not irritating.
- Executive summary:
The test material, when evaluated for primary skin irritation by a 4-hour patch test conducted on intact skin, was found to be not irritating.
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