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EC number: 402-140-1 | CAS number: 17865-32-6 CHMMS; CHMS; DYNASYLAN 9407; Z-6187
- 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
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- 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:
- 30.06.1995 to 14.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohexyldimethoxymethylsilane
- EC Number:
- 402-140-1
- EC Name:
- Cyclohexyldimethoxymethylsilane
- Cas Number:
- 17865-32-6
- Molecular formula:
- C9H20O2Si
- IUPAC Name:
- cyclohexyldimethoxymethylsilane
- 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: David Percival Ltd., UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.38-2.89 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 49-74
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30.06.1995 To: 14.07.1995
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:
- 4 h
- Observation period:
- 14 days (approximately 1, and 24, 48 and 72 hours, and 7 and 14 days after removal of patches)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal flank
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance removed by gentle swabbing with cotton wool soaked in 74% Industrial methylated spirits
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7-14 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: Sum of 24 and 72-hour reading
- Score:
- 4.3
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7-14 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Well-defined erythema and slight to moderate oedema were noted at all treated skin sites one hour after patch removal and at the 24, 48 and 72-hour observations. The erythema extended up to 3 cm beyond one treatment site at the one hour observation and up to 6 cm beyond the remaining treatment sites at the 24, 48 and 72 hour observations.
- Other effects:
- Crust formation was noted at all treated skin sites at the 7-day observation. Crust formation prevented accurate evaluation of erythema at one treated skin site at this time. Desquamation was noted at all treated skin sites 14 days after treatment. This reaction was considered to be reversible.
Any other information on results incl. tables
Table 1 Summary of individual irritation scores
Skin reaction | Observation time | Scores | ||
Animal 1 | Animal 2 | Animal 3 | ||
Erythema | 1 hour | 2R | 2 | 2 |
24 hours | 2R | 2R | 2 | |
48 hours | 2R | 2R | 2 | |
72 hours | 2R | 2R | 2 | |
7 days | ?eCf | 0Cf | 0Cf | |
14 days | 0D | 0D | 0D | |
Oedema | 1 hour | 3 | 2 | 2 |
24 hours | 3 | 2 | 2 | |
48 hours | 3 | 2 | 2 | |
72 hours | 3 | 2 | 2 | |
7 days | 0 | 0 | 0 | |
14 days | 0 | 0 | 0 |
D= desquamation
R= reaction extending up to 3 to 6 cm beyond treatment site
Cf= crust formation
?e= adverse reactions prevent accurate evaluation of erythema
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal irritation study conducted to OECD Test Guideline 404 and in compliance with GLP (reliability score 1) cyclohexyldimethoxymethylsilane was irritating to the skin of rabbits under semi-occlusive conditions, based on persistent, widespread erythema and oedema, with desquamation in all three animals. The irritation was reversible.
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