Registration Dossier
Registration Dossier
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EC number: 405-800-7 | CAS number: 27955-94-8 THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- EC Number:
- 405-800-7
- EC Name:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- Cas Number:
- 27955-94-8
- Molecular formula:
- C20H18O3
- IUPAC Name:
- 4-[1,1-bis(4-hydroxyphenyl)ethyl]phenol
- Details on test material:
- -Purity: 99%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.5-2.9 kg
- Housing: metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were acclimated; period of time not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes after removal of the patches and on Days 2, 3, and 4
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 10 cm square
- % coverage: not reported
- Type of wrap if used: "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM:The Draize Dermal Irritation Scoring System was used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no signs of irritation at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation was observed in any animal throughout the study.
- Executive summary:
The test substance was evaluated for acute skin irritation potential in 3 young adult New Zealand white rabbits. A dose of 0.5 g moistened with 0.5 mL water was applied to the intact skin site under a semiocclusive dressing for 4 hours. The application site was then washed and observed for signs of irritation 30 minutes after removal of the test substance, and subsequently on Days 2, 3, and 4. There were no signs of irritation at any time point.
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