Registration Dossier
Registration Dossier
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EC number: 225-805-6 | CAS number: 5089-70-3
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-26 to 1995-10-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3-chloropropyl)triethoxysilane
- EC Number:
- 225-805-6
- EC Name:
- (3-chloropropyl)triethoxysilane
- Cas Number:
- 5089-70-3
- Molecular formula:
- C9H21ClO3Si
- IUPAC Name:
- (3-chloropropyl)triethoxysilane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: Young adult, age not specified
- Weight at study initiation: 2313 to 2463 g
- Housing: Individual suspended wire-mesh cages
- Diet: Purina Certified Rabbit Chow, ad libitum
- Water municipal water, ad libitum
- Acclimation period: minimum 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 67.5 - 68.6°F (19.4 - 20°C)
- Humidity: 38.4-45.8 %
- Air changes (per hr): not specified
- Photoperiod: 12 hours dark/ 12 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- until no abnormal observations at 11 days
- Number of animals:
- 6 (2 males and 4 females)
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 dorsal skin removed from hair
- % coverage: one inch square
- Type of wrap if used: 2-ply gauze path overwrapped with a gauze binder and se cured with Dermiform tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: at the end of 4 hours
OBSERVATION TIME POINTS
The animals were observed for mortality twice daily (morning and afternoon) for the duration of the study. The applications sites were observed for erythema, oedema, and other dermal findings approximately 30-60 minutes and 24,48 and 72 hours after patch removal and through day 11 if irritation persisted.
Body weights were obtained and recorded on study day 0 (initiation) and at each animal's termination from the study.
Upon termination from the study, the rabbits were euthanized by intravenous injection of sodium pentobarbital solution and discarded.
SCORING SYSTEM:
- Method of calculation: method of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 8
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 19703
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- very slight erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 19707
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- very slight erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 19722
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- 19726
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- probability of weak irritation
- Remarks:
- very slight erythema
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- 19731
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- 19732
- 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
- Remarks:
- 19703
- 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
- Remarks:
- 19707
- 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
- Remarks:
- 19722
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 19726
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- 19731
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- 19732
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test material induced very slight erythema (grade 1) in three of six animals at 24, 48 or 72 hours, and desquamation in all animals from 72 hours. There was no oedema or other dermal findings. All irritation was reversible; erythema and desquamation were no longer evident at day 6 and day 11, respectively. The Primary Irritation Index (mean at 1, 24, 48 and 72 h) was calculated to be 0.4. The test material was described as slightly irritating.
- Other effects:
- There were no deaths or remarkable body weight changes during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study, conducted according to EPA OPP81-5 Test Guideline (similar to OECD Test Guideline 404) and in compliance with GLP, (3-chloropropyl)triethoxysilane did not cause significant irritation and was not corrosive to the rabbit skin.
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