Registration Dossier
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EC number: 252-558-1 | CAS number: 35435-21-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 120 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report Date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. certificate)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing:ABS - plastic cages, floor 4200 cm2
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 55± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
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
- Duration of treatment / exposure:
- Four hours.
- Observation period:
- 120 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not stated
- Type of wrap if used: gauze patch held in place with non-irritating tape and semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water.
- Time after start of exposure: Four hours.
SCORING SYSTEM: As per OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 120 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: No oedema in any of the animals
- Irritant / corrosive response data:
- Very slight to moderate irritant effects (erythema) in all three animals on the intact skin 24 hours after patch removal. Very slight to well-defined skin reactions (erythema) in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. By 120 hours there were no signs of irritation.
- Other effects:
- There were no significant body weight changes at any point in the study. There were no other signs of toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a good quality (reliability 1) primary skin irritation study conducted according to OECD 404 and GLP, Wacker BS 1701 (alkylalkoxysilane) was very slight to moderately irritating to rabbit skin. The observed effects do not warrant classification according to EU criteria.
- Executive summary:
Wacker BS 1701 (alkylalkoxysilane) was applied to one side of the closely clipped backs of three New Zealand white rabbits at a dose of 0.5 ml per application site under a semi-occlusive dressing. The other side of the untreated skin on the backs of the rabbits served as the controls. After the four hour application period, the dressing was removed and excess test substance was washed off the skin with water. Observations were recorded and compared to the control sites at 1, 24, 48, 72, 96 and 120 hours after removal of the dressing. Very slight to moderate irritant effects (erythema) were observed in all three animals after 24 hours. Very slight to well-defined skin reactions (erythema) were observed in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. However, by 120 hours there were no signs of irritation. No clinical signs of toxicity were observed.
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