Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP (Safepharm Laboratories Ltd., 1995a), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats.
In an acute aerosol inhalation
study conducted using a protocol comparable to OECD Test Guideline 403
and in compliance with GLP (Huntingdon Research Centre Ltd., 1990), the
LC50 for cyclohexyldimethoxymethylsilane was greater than 5.53 mg/l in
rats (whole-body).
In an acute dermal toxicity study conducted according to OECD Test Guideline 402 and in compliance with GLP (Safepharm Laboratories Ltd., 1995b), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats. There were no signs of systemic toxicity or dermal irritation.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.07.1995 to 26.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males: 155-187 g; Females: 126-146 g
- Fasting period before study: yes
- Housing: Groups of five in polypropylene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 47-66
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06.07.1995 To: 26.07.1995 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.14 ml/kg
- Doses:
- 2000 mg/kg bw/day
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity half, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test substance was made.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Common signs of systemic toxicity were hunched posture, lethargy, ataxia and reduced breathing rate with additional signs of laboured breathing, loss of righting reflex and ptosis. One male was comatose four hours after dosing. Animals returned to normal
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Organ weights: Not measured
- Histopathology: Not conducted
- Potential target organs: None identified - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP (reliability score 1), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats. Common signs of systemic toxicity were hunched posture, lethargy, ataxia and reduced breathing rate with additional signs of laboured breathing, loss of righting reflex and ptosis. One male was comatose four hours after dosing. Animals returned to normal within one day of dosing. There were no other adverse findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.10.1989 to 27.10.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd
- Age at study initiation: 6-8 weeks (on arrival at lab)
- Weight at study initiation: Approximately 200 g
- Fasting period before study: No
- Housing: Polypropylene cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 35-65
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 04.10.1989 To: 27.10.1989 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The whole body exposure chambers were of square section and were fitted with pyramidal tops. The chambers were made of perspex.
- Exposure chamber volume: 120 litres
- Method of holding animals in test chamber: Each chamber was divided by wire mesh partitions to provide 10 separate animal compartments.
- Source and rate of air: Described as 'clean, dried air', which was connected to the aerosol generator and the supply pressure was adjusted to give a flow rate of 25 litres/minute measured at the generator outlet tube.
- Method of conditioning air: The compressed air supply to the generator was dried, filtered and oil-free.
- System of generating aerosols: The generator was designed to produce and maintain an atmosphere containing a high proportion of respirable droplets. A flow rate of 0.5 ml/minute test substance to the atomiser was expected to give a concentration of aerosol just in excess of 5 mg/l of air.
- Method of particle size determination: Two samples were taken using a May multistage liquid impinger with acetone/methanol as the trapping agent in each stage (stage 1 - particles >5.5 micrometres; stage 2 - 5.5 to 2.0 micrometres; stage 3 - <2.0 micrometres). The contents of the stages were analysed to determine the particle size distribution in the atmosphere.
- Treatment of exhaust air: Each chamber was positioned inside a large glass walled cabinet equipped with an extractor fan exhausting to atmosphere through a collection filter.
- Temperature, humidity, pressure in air chamber: Approximately 23oC. No data for humidity or chamber pressure.
TEST ATMOSPHERE
- Brief description of analytical method used: Five air samples were taken from the chamber during each exposure and analysed to determine the concentration of test substance. The samples were drawn through an absorption trap, containing approximately 20ml of acetone, at a sampling rate of 2 litres/minute.
- Samples taken from breathing zone: no data
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 81% in respirable range (<5.5 micrometres) - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.53 mg/l
- No. of animals per sex per dose:
- Five
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed continuously during the exposure period for signs of toxicity, and twice daily during the observation period of 14 days. All rats were weighed daily.
- Necropsy of survivors performed: yes
- Other examinations performed: Food and water consumption was measured by cage. At the end of the observation period a detailed macroscopic examination was conducted. Lungs weights were measured. Lungs, liver and kidneys were examined microscopically. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.53 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: No deaths
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Partial closing of the eyes, hunched/prone posture, wet snout and slow breathing rate were observed, but are considered consistent with exposure to a mildly irritant aerosol. Wet fur, slow breathing rate, staggering and sensitivity to touch were observed,
- Body weight:
- There was an initial loss of weight or reduced bodyweight gain 1 -2 days after exposure. Subsequently, there was no difference between controls and treated animals.
- Gross pathology:
- Lung weights were normal. There were no abnormal macro- or micro-scopic findings.
- Other findings:
- Food consumption was reduced for 1 -2 days following exposure.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute aerosol inhalation study conducted using a protocol comparable to OECD Test Guideline 403 and in compliance with GLP (reliability score 1), the LC50 for cyclohexyldimethoxymethylsilane was greater than 5.53 mg/l in rats (whole-body). Wet fur, slow breathing rate, staggering and sensitivity to touch were observed, but only on the first day. All animals were normal by Day 1 of the observation period. There was an initial loss of weight or reduced bodyweight gain 1 -2 days after exposure. Subsequently, there was no difference between controls and treated animals. Food consumption was reduced for 1 -2 days following exposure. Lung weights were normal. There were no abnormal macro- or microscopic findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.53 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.07.1995 to 26.07.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC, Method B3
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 10-14 weeks
- Weight at study initiation: Males: 210-238 g; Females: 201-234 g
- Fasting period before study: No
- Housing: Individual during exposure period, and groups of 5/6 at other times, in suspended polypropylene 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): 19-25
- Humidity (%): 49-60
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12.07.1995 To: 26.07.1995 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and flanks
- % coverage: Approximately 10%
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with moist cotton wool
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 ml/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were checked for mortality and signs of toxicity at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily thereafter. Individual bodyweights were recorded prior to application of the test substance on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: dermal for signs of irritation, macroscopic examination - Statistics:
- Mortality data were used to calculate the acute dermal median lethal dose.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were observed.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No signs of irritation were observed.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity study conducted to OECD Test Guideline 402 and in compliacne with GLP (reliability score 1), the LD50 for cyclohexyldimethoxymethylsilane was at least 2000 mg/kg bw in rats. There were no signs of systemic toxicity or dermal irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
There are several acute studies available for each route of exposure. For each route the most recent reliable study has been selected as the key study. The other available reliable studies provide supporting evidence for the low acute toxicity of cyclohexyl(dimethoxy)methylsilane.
In the key acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP (Safepharm Laboratories Ltd., 1995a), the LD50 for cyclohexyl(dimethoxy)methylsilane was greater than 2000 mg/kg bw in rats.
Common signs of systemic toxicity were hunched posture, lethargy, ataxia and reduced breathing rate with additional signs of laboured breathing, loss of righting reflex and ptosis. One male was comatose four hours after dosing. Animals returned to normal within one day of dosing. There were no other adverse findings.
In a supporting acute oral toxicity study conducted using a protocol comparable to the now deleted OECD Test Guideline 401 and in compliance with GLP (reliability score 1), the male and female combined LD50 for cyclohexyl(dimethoxy)methylsilane was 4071 mg/kg bw in rats (Life Science Research., 1987a). Loss of consciousness was observed at all dose levels, and the animals had in all cases recovered by the second day after treatment. Other clinical signs were irritability, hypo- and hyperactivity, ataxia, hunched posture, flaccid musculature, pallor, cyanosis, pigmented staining of the snout, pigmented orbital secretion, salivation, urogenital soiling, incontinence, ungroomed appearance, piloerection, dorsal hairloss and lacrimation.
In another supporting acute oral toxicity study conducted using a protocol comparable to the now deleted OECD Test Guideline 401, but not in compliance with GLP (reliability score 2), the LD50 for cyclohexyl(dimethoxy)methylsilane was 3000 mg/kg bw (male and female combined) in rats (Huntingdon Research Centre Ltd., 1988a).
In the key acute aerosol inhalation study conducted using a protocol comparable to OECD Test Guideline 403 and in compliance with GLP (Huntingdon Research Centre Ltd., 1990), the LC50 for cyclohexyl(dimethoxy)methylsilane was greater than 5.53 mg/l in rats (whole-body). Wet fur, slow breathing rate, staggering and sensitivity to touch were observed, but only on the first day. All animals were normal by Day 1 of the observation period. There was an initial loss of weight or reduced bodyweight gain 1 -2 days after exposure. Subsequently, there was no difference between controls and treated animals. Food consumption was reduced for 1 -2 days following exposure. Lung weights were normal. There were no abnormal macro- or microscopic findings.
In a supporting acute vapour inhalation study conducted using a protocol comparable to OECD Test Guideline 403 with acceptable restrictions (reliability score 2 based on test concentration being too low - 20 mg/l in guideline compared with 2.06 mg/l tested) and in compliance with GLP, the LC50 for cyclohexyl(dimethoxy)methylsilane in rats was greater than 2.06 mg/l (Dow Corning Corporation., 1990)
In another acute aerosol inhalation study conducted according to OECD Test Guideline 403 (except no test substance purity information) and in compliance with GLP (reliability score 1), the LC50 for cyclohexyl(dimethoxy)methylsilane was greater than 5.03 mg/l in rats (nose only). Clinical signs immediately after exposure were ataxia, wet fur, exaggerated respiratory movements (persisted until Day 2), reduced respiratory rate and torpidity. After Day 2 all rats were normal in appearance and behaviour. There was no effect on bodyweight. Liver weights were higher than expected, particularly in males. There were no changes noted at necropsy (Life Science Research Ltd., 1988).
In an acute dermal toxicity study conducted to OECD Test Guideline 402 and in compliance with GLP (reliability score 1), the LD50 for cyclohexyl(dimethoxy)methylsilane was at least 2000 mg/kg bw in rats. There were no signs of systemic toxicity or dermal irritation. The same results were found in two other supporting studies conducted according to the same OECD Test Guideline 402 and in compliance with GLP (Life Science Research., 1987b and Huntingdon Research Centre Ltd., 1989a).
Justification for classification or non-classification
Based on the available acute toxicity data, cyclohexyl(dimethoxy)methylsilane is not classified for acute toxicity or specific target organ toxicity following single exposures according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.