Registration Dossier
Registration Dossier
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EC number: 241-881-3 | CAS number: 17955-88-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-09-18 to 2001-09-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 92/69/EEC, Annex Part B, Method B4 Acute Toxicity (Skin Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA: OPPTS 870.2500, Health Effects Test Guidelines: Acute Dermal Irritation, August 1998
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- EC Number:
- 241-881-3
- EC Name:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- Cas Number:
- 17955-88-3
- Molecular formula:
- C15H38O2Si3
- IUPAC Name:
- 2,2,4,6,6-pentamethyl-4-octyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: no data
- Weight at study initiation: 3.38 - 3.52 kg
- Housing: in separate cages arranged in battery
- Diet: ssniff K-H (V2333), ad libitum and hay approximately 15 g a day
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- At 30 and 60 min, then at 24, 48 and 72 hours post-application
- Number of animals:
- 3 female animals
- Details on study design:
- TEST SITE
- Area of exposure: dorsal region
- % coverage: no data. 25 cm² area of the total body surface was treated
- Type of wrap if used: surgical plaster covered with semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water was used to remover residual test item
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
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:
- No signs of irritation were observed in any of the animals during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin irritation study the test substance, 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane, was concluded to be not irritating to rabbit skin.
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