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EC number: 247-744-4 | CAS number: 26495-91-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 12 - March 29, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- revised in 1997
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 454-780-6
- EC Name:
- -
- Cas Number:
- 27445-54-1
- Molecular formula:
- Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si
- IUPAC Name:
- Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals
New Zealand White Rabbits Hsdlf:NZW. Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Three female animals were used. Body weight at the commencement of the study: 4.1 kg; 3.9 kg; 3.7 kg
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Animal Husbandry
Semi-barrier in an air conditioned room
Temperature: 18 ± 3°C
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
Eyes were not rinsed.
The eyes were examined for signs of irritation throughout the observation period. Eye irritation was scored and recorded according to the grades in the table below.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Animal No. 1 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness had decreased to grade 1, chemosis and discharge had disappeared. 48 hours postdose all symptoms had disappeared.
Animal No. 2 showed redness as well as chemosis grade 2 and discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness was unchanged (grade 2), chemosis had decreased to grade 1 and discharge had disappeared. 48 hours post-dose only redness of the conjunctivae grade 1 was still observed and 72 hours post-dose all symptoms had disappeared.
Animal No. 3 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness had decreased to grade 1, chemosis and discharge had disappeared. 48 hours postdose all symptoms had disappeared.
The test item produced no corrosion or irreversible effects in any of the animals. No comeallesions were found upon fluorescein examination at the final reading. - Other effects:
- No other toxic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced slight eye irritation below the criteria for classification and labelling.
- Executive summary:
The test for acute eye irritation/corrosion according to OECD Guideline No. 405 was performed with the test item.
In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of 3 female NZW - rabbits (HsdIf:NZW) at a dose of 0.1 mL per application site. The untreated other eye served as control.
Considering the reported data of this irritation study it can be stated that the test item produced slight irritation but no corrosive effects.
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