Registration Dossier
Registration Dossier
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EC number: 405-800-7 | CAS number: 27955-94-8
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:
- other: GLP study in accordance with relevant guideline; selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- other: reference to body responsible for the test
- 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:
- Study was conducted according to guideline in effect at time of study.
- 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:
- 4,4',4''-(ethan-1,1,1-triyl)triphenol
- 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; time period 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:
- other: Distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per test organism.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL per test organism. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 30 minutes after removal of coverage patches, and on day 2, 3 and 4.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 10 cm2
- % coverage: Not reported.
- Type of wrap if used: 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
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- other: No response observed to test substance treatment.
- Basis:
- other: All test organisms: 3 animals
- Time point:
- other: Through day 4
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There were no signs of irritation at any time observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No response to application of the test substance was observed at any time during the observation period.
- Executive summary:
The test substance was evaluated for the potential for acute skin irritation in rabbits. A dose of 0.5 g test substance 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. Observations were made after removal at 30 minutes and on Days 2, 3, and 4 after removal of the test substance. There were no signs of irritation at any time.
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