Registration Dossier
Registration Dossier
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EC number: 271-867-2 | CAS number: 68610-51-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 - 18 November, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according OECD Guideline 404 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- EC Number:
- 271-867-2
- EC Name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- Cas Number:
- 68610-51-5
- Molecular formula:
- C10H12.C7H8O.C4H8
- IUPAC Name:
- 2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol
- Details on test material:
- -Name of test material (as cited in study report): Wingstay L
- Substance type: tan solid
- Physical state: solid
- Analytical purity: not stated in the report
- Impurities (identity and concentrations): not stated in the report
- Composition of test material, percentage of components: not stated in the report
- Purity test date: not stated in the report
- Lot/batch No.: 211093
- Expiration date of the lot/batch: May 2000
- Stability under test conditions: not stated in the report
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare Marland
- Age at study initiation: 18 weeks
- Weight at study initiation: 2.554 - 3.446 kg
- Housing: individually in steenless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -21
- Humidity (%): 40 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/site - Duration of treatment / exposure:
- 3, 60 minutes, 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 males, 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: elastic bandage and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at end of exposure time
SCORING SYSTEM: scoring system of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 min. exposure
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 min exposure
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min exposure
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min exposure
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: concerns 1/6 animals, score 1, only at t=48 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 hour
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Dermal irritation:
Exposure 3 minutes: no erythema, no edema
Exposure 60 minutes: very slight erythema, no edema
Exposure 4 hours: very slight erythema, no edema
Corrosivity:
No necrosis observed. - Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information non-corrosive Criteria used for interpretation of results: OECD GHS
- Conclusions:
- A study in 3 male and 3 female rabbits revealed that Wingstay L was slightly irritant after 4-hour exposure. The test substance was considered non-corrosive. The study was performed according to the general guidelines for acute dermal irritation/corrosion under GLP conditions.
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