Registration Dossier
Registration Dossier
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EC number: 211-659-0 | CAS number: 682-01-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.04.2002 to 12.08.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetrapropyl orthosilicate
- EC Number:
- 211-659-0
- EC Name:
- Tetrapropyl orthosilicate
- Cas Number:
- 682-01-9
- Molecular formula:
- C12H28O4Si
- IUPAC Name:
- tetrapropyl silicate
- Details on test material:
- - Name of test material (as cited in study report): Silan TPN
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions: Stable for >1 year at 25oC
- Storage condition of test material: at room temperature, dry, tightly closed.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology
- Age at study initiation: Approximately 3.5 months
- Weight at study initiation: 2.0-2.1 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): Ad libitum except during exposure
- Water (e.g. ad libitum): Ad libitum except during exposure
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17.04.2002 To: 03.05.2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml to test site area of 6cm2.
- Duration of treatment / exposure:
- Four hours.
- Observation period:
- Eight days.
- Number of animals:
- Three males.
- Details on study design:
- TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: Semi-occlusive non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: Not removed
SCORING SYSTEM: According to OECD 404 at 60 minutes, 24, 48, 72 hours and 4 to 8 days after the patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine reversibility or irreversibility of the reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 and 2
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No sign of edema in any of the animals.
- Irritant / corrosive response data:
- As above
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation study conducted to OECD 404 and to GLP (reliability score 1), tetrapropyl orthosilicate was not irritating to the skin of rabbits.
- Executive summary:
Three Himalayan rabbits were exposed for four hours to 0.5 ml Silan TPN under semi-occlusive conditions on intact skin. The reactions of the intact skin were evaluated 60 minutes and then 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions. An erythema (grade 1) was noted in two animals from 60 minutes up to seven days after the patch was removed. In the third animal, erythema (grade 1) was observed from 60 minutes up to 24 hours after the patch was removed.
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