Registration Dossier
Registration Dossier
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EC number: 221-339-2 | CAS number: 3069-42-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Sep - 01 Oct 2000
- 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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trimethoxyoctadecylsilane
- EC Number:
- 221-339-2
- EC Name:
- Trimethoxyoctadecylsilane
- Cas Number:
- 3069-42-9
- Molecular formula:
- C21H46O3Si
- IUPAC Name:
- trimethoxyoctadecylsilane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adults
- Weight at study initiation: 2750 – 2981 g
- Housing: animals were caged in individually suspended wire-mesh cages
- Diet: PMI Nutrition International, Inc. certified rabbit LabDiet 5322, approximately 150 g per day during the study
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 – 20.0
- Humidity (%): 50 - 59
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 30 - 60 min, 24, 48 and 72 h - Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm² of clipped skin of the back and flanks
- Type of wrap if used: a piece of two-ply gauze patch was placed over the treatment area and secured in place with Micropore tape. The patches were overwrapped with a gauze binder and secured with Dermiform tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article and/or bandages.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with disposable paper towels moistened with deionized water.
- Time after start of exposure: 4 h
SCORING SYSTEM
- Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No mortalities occurred during the study period. The test article induced very slight erythema (grade 1) on one animal 30 – 60 min post-application. There was no edema, nor were there any other dermal findings. Based on the results of the study the test item should be considered as non-irritant.
- Other effects:
- There were no remarkable body weight changes during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- Treatment of 3 New Zealand White rabbits under semi-occlusive conditions with 0.5 ml undiluted test substance induced very slight erythema (grade 1) on one animal 30 – 60 min post-application but being fully reversible within 24 h. There was no edema, nor were there any other dermal findings. Based on the results of the study the test item should be considered as non-irritant.
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