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EC number: 233-487-5 | CAS number: 10196-49-3
- 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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CFR, title 16, section 1500.42
- GLP compliance:
- no
- Remarks:
- study conducted prior to implementation of GLP
Test material
- Reference substance name:
- 2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
- EC Number:
- 233-487-5
- EC Name:
- 2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane
- Cas Number:
- 10196-49-3
- Molecular formula:
- C6H15NOSi
- IUPAC Name:
- 2,2,4-trimethyl-1,4,2-oxazasilinane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal 1
- Weight at study initiation: 2.6 kg (average)
- Housing: each animal in separate cage
- Diet (e.g. ad libitum): mümmel z (sniff / Soest), ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°C
- Humidity (%): 40% r.h.
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 µL - Duration of treatment / exposure:
- not applicable (eye was not rinsed after treatment)
- Observation period (in vivo):
- 24/48/72 hours as well as 8 days after start of treatment.
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- SCORING SYSTEM:
Scoring according to "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51".
TOOL USED TO ASSESS SCORE: ophthalmoscope 24/48/72 hours (fluorescein after 8 days; not considered for scoring)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1-#3,#6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #4,#5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: #1-#6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2,#4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3,#5,#6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Irritation effects were observed in all animals and at all irritation parameters. No effect was fully reversible and most effects were not reversible at all. Opthalmoscopic fluorescine observations on eyes rinsed with NaCl 8 days after treatment showed worsen cornea opacity score of 3.33 (average of animals #1-#6).
Any other information on results incl. tables
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 |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
2/2/2/1/1/2 |
1/1/1/1/1/1 |
2/3/2/3/2/2 |
2/2/2/3/3/2 |
48 h |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
3/2/2/2/2/2 |
2/2/3/3/3/3 |
72 h |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
3/2/2/2/2/2 |
2/2/3/3/4/2 |
Average 24h, 48h, 72h |
1.33/1.33/1.33/1/1/1.33 |
1/1/1/1/1/1 |
2.67/2.33/2/2.33/2/2 |
2/2/2.67/3/3.33/2.33 |
Reversibility*) |
n.c./n.c./n.c./n./n./n.c. |
n./n./n./n./n./n. |
n./n.c./n./n.c./n./n. |
n./n./n./n./n./n. |
Average time (unit) for reversion |
48 hrs |
-- |
-- |
-- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In this study, the test substance showed irreversible effects on the eyes.
- Executive summary:
In a primary eye irritation study performed in accordance with the Code of Federal Regulations, Title 16, Section 1500.42 (Test for eye irritants), the test substance was instilled into the right eye’s conjunctival sac of adult male albino rabbits (strain New Zealand White) followed by lid close for 1 second. The treated eyes were not washed after treatment. The left untreated eyes served as controls.
Animals then were observed for 8 days with score relevant observations being carried out at 24/48/72 hours after treatment. Irritation was scored by the method described in “The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51”.
Irritation effects were observed in all animals and at all irritation parameters. No effect was fully reversible and most effects were not reversible at all. Opthalmoscopic fluorescine observations on eyes rinsed with NaCl 8 days after treatment showed worsen cornea opacity score of 3.33 (average of animals #1-#6). In this study, the test substance is a strong eye irritant (GHS Cat 1).
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Eye Damage 1 (H318: Causes serious eye damage) is justified.
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