Registration Dossier
Registration Dossier
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EC number: 222-222-9 | CAS number: 3390-61-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-10 to 2002-06-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane
- EC Number:
- 222-222-9
- EC Name:
- 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane
- Cas Number:
- 3390-61-2
- Molecular formula:
- C33H34O2Si3
- IUPAC Name:
- 4-methyl-2,2,4,6,6-pentaphenyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmachology and Toxicology KG, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: kept singly in cages
- Diet: standard diet for rabbits, ssniff K-H, ad libitum
- Water: drinking water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 55 % +/- 15 %
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- at 60 minutes, 24, 48 and 72 hours post-application, then every day for 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: the area was approximately 6 cm2
- Type of wrap if used: the substance was applied to the exposure area, covered with a gauze patch and held in contact with the skin by means of semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring systhem
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:
- A very slight/barely perceptible erythema was observed at 60 minutes after patch removal in all the animals. No oedema was observed in any of the test animals.
- Other effects:
- No other effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study, conducted according to OECD TG 404 and under GLP, the test material, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane , was reported to be not irritating to rabbit skin.
- Executive summary:
1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was tested in a reliable study for skin irritation/corrosion. The study was conducted according to OECD TG 404, and in compliance with GLP.
0.5 mL of 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was applied undiluted onto the skin of 3 rabbits and kept in contact with the skin for 4 hours under semi-occlusive dressing. The exposure area was evaluated for skin irritation/corrosion according to Draize scoring systhem at 60 minutes, 24, 48 and 72 hours after removal of the patch.
Very slight erythema was observed at 60 minutes post-treatment in all the test animals, but fully reversible within 24 hours. No oedema was noted in any of the rabbits. The test material, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit skin.
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