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EC number: 304-835-4 | CAS number: 94279-90-0
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 April 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to well-documented and supported procedures for which no guideline (OECD, etc.) exists
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The ocular irritancy potential of the test material was assessed after application onto the cornea of an enucleated rabbit eye.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Rape oil, bisulfited, sodium salt
- EC Number:
- 281-975-1
- EC Name:
- Rape oil, bisulfited, sodium salt
- Cas Number:
- 84082-27-9
- IUPAC Name:
- Rape oil, bisulfited, sodium salt
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Selection: eyes were examined for evidence of ocular irritation or defect, and corneal thickness was measured
- All other template details: not applicable
ENVIRONMENTAL CONDITIONS of Superfusion Chamber after Enucleation
- Temperature (°C): 32 +/- 1.5 degrees C
- Humidity (%): not applicable
- Flow rate: peristaltic pump was used to supply saline solution at a flow rate of 0.15-0.4 ml/min to irrigate the surface of the cornea
- Photoperiod (hrs dark / hrs light): not applicable
IN-LIFE DATES: not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml applied as evenly as possible to the surface of the cornea
VEHICLE: Not applicable - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- assessment of corneal cloudiness was made pre-enucleation, post equilibration and 60, 120, 180, and 240 minutes following treatment
- Number of animals or in vitro replicates:
- 3 eyes treated with test material, two eyes untreated as controls
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): using a minimum of 20 ml of saline solution (approximately 32 degrees C)
- Time after start of exposure: 10 seconds
SCORING SYSTEM: numerical evaluation adopted from 'Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.'
TOOL USED TO ASSESS SCORE: fluorescein and slit lamp biomicroscope, and thickness of cornea was measured using an ultrasonic pachymeter.
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 240 minutes
- Value:
- 0
- Vehicle controls validity:
- other: all scores for corneal opacity for 2 control eyes were 0.
- Remarks on result:
- other: all scores for corneal opacity for 3 test eyes and 2 control eyes were 0 at 60, 120, 180, 240 minutes post exposure
- Other effects / acceptance of results:
- - No fluorescein uptake was noted in the test eyes or control eyes 240 minutes after treatment.
- Determination of corneal swelling: See Table 3
Any other information on results incl. tables
Table 3. Determination of Corneal Swelling (%)
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: other: scoring from Hacket and McDonald 1991
- Conclusions:
- The test material was not considered to be an ocular irritant from application of the substance to the enucleated rabbit eye.
- Executive summary:
Study report summary:
Introduction. A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
Methods. 0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32oC±1.5oC within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Results. Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Swelling (%)
Condition of Corneal Epithelium
Corneal Opacity
Fluorescein Uptake
Test Eyes
Control Eyes
Cldy x Area
Int x Area
60 mins
120 mins
240 mins
60 mins
120 mins
240 mins
0
0
9.5
10.3
10.1
6.1
6.7
10.0
normal
Conclusion. Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
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