Registration Dossier
Registration Dossier
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EC number: 240-464-3 | CAS number: 16415-12-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Apr 2002 to 12 Aug 2002
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 1992)
- 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:
- Hexadecyltrimethoxysilane
- EC Number:
- 240-464-3
- EC Name:
- Hexadecyltrimethoxysilane
- Cas Number:
- 16415-12-6
- Molecular formula:
- C19H42O3Si
- IUPAC Name:
- hexadecyltrimethoxysilane
- Details on test material:
- - Name of test material (as cited in study report): Silan 25013 VP
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: at 25oC: >1 year
- Storage condition of test material: Room temperature, excluded humidity, tightly closed.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhndorf/Wankendorf, Germany
- Age at study initiation: 2-2.5 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individually in cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15.04.2002 To: 30.04.2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72h, 4 and 5 days
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of trunk
- % coverage: No data, but area was 6 cm².
- Type of wrap if used: Gauze patch held in place with non-irritating tape (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize scoring system
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
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- No systemic effects reported.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema and eschar |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
0/0/1 |
0/0/0 |
24 h |
0/0/1 |
0/0/0 |
48 h |
0/0/1 |
0/0/0 |
72 h |
0/0/1 |
0/0/0 |
4 days |
-/-/1 |
-/-/0 |
5 days |
-/-/0 |
-/-/0 |
Average 24h, 48h, 72h |
0/0/1 |
0/0/0 |
Reversibility* |
c |
n/a |
Time for reversion |
Day 5 |
- |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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:
- In a skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), hexadecyl(trimethoxy)silane was minimally transiently irritating to the skin of one of three rabbits. There were no systemic effects reported.
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