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EC number: 265-477-1 | CAS number: 65122-06-7
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Source study has reliability 1; details on the read-across approach are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: 3.5 kg
- Accommodation: individual cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 hours light and 12 hours dark
Test system
- Controls:
- other: untreated eye used as control
- Amount / concentration applied:
- 0.1 g test substance.
- Duration of treatment / exposure:
- 24 hours.
- Number of animals or in vitro replicates:
- 3 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, with physiological solution of NaCl.
- Time after start of exposure: 24 hours.
SCORING SYSTEM: Draize scale for ocular lesions (1944)
Cornea
Degree of opacity (most dense area used)
0 no opacity
1 scattered or diffuse areas, details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 opalescent areas, no details of iris visible, size of pupil barely discernible
4 opaque cornea, iris invisible
Area of cornea involved:
1 one quarter or less but not zero
2 greater than one quarter, but less than half
3 greater than half, but less than three quarters
4 greater than three quarters, up to whole area
Iris
0 normal
1 folds above normal, congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrhage, gross detsruction (any or all of these)
Conjuctivae
Redness (refers to palpebral and bulbar conjuctivae, excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red
Chemosis:
0 no swelling
1 any swelling above normal (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids more than half closed
Discharge:
0 no discharge
1 any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 discharge with moistening of the lids and hairs just adjacent to lids
3 discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE: one drop of 1 % fluorescein applied in the eye, then rinse with physiological NaCl solution and examination under UV light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2/3
- Time point:
- other: 24, 48, 72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1/3
- Time point:
- other: 24, 48, 72 h
- Score:
- > 1
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 h
- Score:
- < 1
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- other: 24, 48, 72 h
- Score:
- < 2
- Reversibility:
- fully reversible within: 21 d
Any other information on results incl. tables
1h | 24h | 48h | 72h | 7d | 21d | |||||||||||||
animal | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
corneal opacicity | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 1 | 2 | 0 | 0 | 2 | 0 | - | 0 | - |
corneal surface | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 2 | 0 | 1 | 2 | 0 | 0 | 4 | 0 | - | 0 | - |
iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 0 | - |
conjuctivae redness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 0 | - |
chemosis | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | - | 0 | - |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Under test conditions, the substance is not irritant to the rabbit eye.
- Executive summary:
Method
Eye irritation study was conducted in 3 male rabbits by instillation of 0.1 g of test material into one eye (the other eye serves as control). After 24 hours, rinse of eye was done with physiological NaCl solution. Observation and scoring were carried out at 1h, 24 h, 48 h, 72 h, 7 d and 21 d after application, based on the Draize scale (1944).
Result
Animals were observed for corneal opacity, iritis, conjuctival redness and chemosis. A score was associated to each animal at each time point. Evaluation was done averaging over results at 24, 48 and 72 hours and considering reversibility within 21 days. All responses were fully reversible within 21 days.
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