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EC number: 405-800-7 | CAS number: 27955-94-8 THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
Endpoint summary
Administrative data
Description of key information
Skin: EU Method B.4, rabbit. No irritation. Reliability = 1
Eye: EU Method B.5, rabbit. Reversible mild irritation. Reliability = 1
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance did not produce skin irritation in the rabbit; eye irritation in the rabbit was reversible.
Justification for classification or non-classification
The test substance did not produce skin irritation and eye irritation was mild and reversible. The substance does not need to be classified for irritation according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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