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EC number: 269-950-3 | CAS number: 68391-42-4
- 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
- Study period:
- From February, 2 to March 9, 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- for some descriptions and examinations; but it did not affect the validity of the study
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Breeder: Interfauna U.K. ltd.
Acclimatization period: at least 14 d
Body weight: 3.1-3.5 kg
Room temperature: 21 ± 1.5 °C
Humidity: 40 - 70 %
Light period: 12 h light/12 h dark
Diet and water: standard diet "Ssniff K4" and tap water, ad libitum
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- approx. 68 mg (in 100 µl)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- After gently pulling the lower lid away from the eyeball, a volume of 100 µl of the pulverized test substance (equivalent to approx. 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after application of the test substance the treated eye was rinsed with normal saline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to rabbit eye.
- Executive summary:
Method
Study conducted according to OECD guideline 405. Three female New Zealand White rabbits were exposed to test substance for 24 h. After gently pulling the lower lid away from the eye, a volume of 100 µl of pulverized test substance (equivalent to approximately 68 mg) was placed into the conjunctival sac of one eye of each rabbit. The lids were then gently held together for about one second in order to limit loss of the material. 24 h after instillation of the test substance, the treated eye was rinsed with normal saline.
Eye irritation (Draize scoring): signs of cornea (opacity, and area affected), iris (hyperaemia, reaction to light), conjunctivae i.e. conjunctiva of bulbus, lids, and nictitating membrane (erythema, chemosis), and discharge were recorded after 1, 24, 48, 72 h and 7 d. In parallel, the opacity of the aqueous humour (McDonald and Shadduck method) was also assessed for potential epithelial damage.
Results
Effects on conjunctivae in terms of chemosis and redness were noted in rabbits. However, slight reactions of the mucous membranes were fully reversible within 7 d. Test substance was not irritant to rabbit eye.
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