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EC number: 425-660-0 | CAS number: 165101-57-5
- 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:
- 1997-04-15 to 1997-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- February 24th 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- July 31st 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 425-660-0
- EC Name:
- -
- Cas Number:
- 165101-57-5
- Molecular formula:
- C14H29NO
- IUPAC Name:
- 3-butyl-2-(heptan-3-yl)-1,3-oxazolidine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.44-2.60 kg
- Housing: individually in floor-pens (floor area 0.6 m2)
- Diet: SQC TRB Rabbit Diet 9603 (pelleted), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 40-80
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 4 days (condition of the treated eye was confirmed normal on day 4)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- SCORING SYSTEM:
Cornea - degree of opacity (area most dense assessed)
No ulceration or opacity 0
Scattered or diffuse areas of opacity other than
slight dulling of normal lustre, details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible but size of pupil barely discernible 3
Opaque cornea, iris not discernible through opacity 4
Cornea - area of corneal opacity
Total area of opacity amounts to <25% of corneal area 1
Area of opacity amounts to 25-<50% of corneal area 2
Area of opacity amounts to 50- < 75 % of corneal area 3
Area of opacity amounts to 75 % or more of corneal area 4
Iris Grade
No reaction 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia or injection, any of these or any
combination thereof; iris still reacting to light 1
No iridial reflex to light, haemorrhage or gross destruction
(any or all of these) 2
Conjunctivae - redness
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red appearance 3
Conjunctivae - Chemosis
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4
Conjunctivae - discharge
No discharge 0
Any discharge greater than normal, not including the small
amount normally present in the inner canthus 1
Discharge with moistening of eyelids and hairs just
adjacent to the eye 2
Discharge with moistening of eyelids and hair for a
considerable area around the eye 3
TOOL USED TO ASSESS SCORE: The treated eyes were examined visually and, where appropriate, with the aid of a device to illuminate or magnify the eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of Incozol 2 elicited a slight initial sting response from the sentinel rabbit but practically no reaction from the other two animals. Injection of the conjunctival vasculature was apparent in all three rabbits during the initial four hour observation period following instillation with a slight ocular discharge also produced in this period. The eyes of all rabbits were overtly normal by the 24 hour examination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the findings in this eye irritation study on New Zealand white rabbits, Incozol 2 is not irritating to the eye.
- Executive summary:
This study was conducted to determine the irritation caused to the rabbit eye following a single instillation of Incozol 2 into the conjunctival sac. The method followed was in compliance with that described in EU Method B5 and OECD TG 405. The undiluted test article (0.1 mL) was instilled into one conjunctival sac of each of three New Zealand White rabbits. Ocular reactions were assessed for three days after treatment. Instillation of Incozol 2 elicited a slight initial sting response from the sentinel rabbit but practically no reaction from the other two animals. Injection of the conjunctival vasculature was apparent in all three rabbits during the initial four hour observation period following instillation with a slight ocular discharge also produced in this period. The cornea and iris were overtly unaffected by treatment. The eyes of all rabbits were overtly normal by the 24 hour examination. Therefore the tested substance was regarded as non irritating to the eye (Covance, 1997).
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