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EC number: 236-144-8 | CAS number: 13189-00-9
- 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
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- 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:
- 15-22 June 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 405 with deviations: temperature and humidity of animal room was not reported; animals were not observed for 21 days to study the reversibility; purity of test item not reported
Cross-referenceopen allclose all
- Reason / purpose:
- reference to same study
- Reason / purpose:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report Date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature and humidity of animal room was not reported; animals were not observed for 21 days to study the reversibility; purity of test item not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): SR-365C
- Physical state: White powder
- Date received: 11 June 1993
- Storage condition of test material: Room temperature and humidity
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.3 kg
- Housing: Animals were housed individually in a suspended wire cage.
- Diet: Fresh Purina Rabbit Chow (Diet #5321), ad libitum
- Water: Water, ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Used as received - Duration of treatment / exposure:
- No washing was done
- Observation period (in vivo):
- 7 days (1 h after administration, Days 1, 2, 3 and 7)
- Number of animals or in vitro replicates:
- One female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD Guideline 405
TOOL USED TO ASSESS SCORE: A hand held source of illumination was used to aid in scoring.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- - Corneal opacity, iritis and moderate conjunctival irritation persisted through Day 7 with apparition of mis-shaped cornea and no sign of reversibility. There were no abnormal physical signs noted during the observation period.
- Other effects:
- None
Any other information on results incl. tables
See attached Document for Tables of Results
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, test item, SR-365C showed irreversible signs of eye irritation (mis-shaped cornea and no reversible scores within 7 days) therefore the test item is classified as “R41 Risk of serious damage to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the CLP Regulation (EC) N° 1272-2008.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, one healthy female rabbit of the New Zealand White strain was exposed to 0.1 mL of undiluted test item SR-365C in their left eye while the right eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test item. The eyes were examined and the changes were observed at 1 h and Days 1, 2, 3 and 7 after treatment and graded according to the method of OECD Guideline 405.
Corneal opacity, iritis and moderate conjunctival irritation persisted through Day 7 with apparition of mis-shaped cornea and no sign of reversibility. There were no abnormal physical signs noted during the observation period. Mean individual scores at 24, 48 and 72 h after exposure for one animal was 2.3, 1.0, 2.7 and 3.0 for cornea, iris, conjunctivae and chemosis, respectively. In this study, test item, SR-365C is considered to show irreversible signs of eye irritation on female rabbit.
Under the test conditions, test item, SR-365C showed irreversible signs of eye irritation (mis-shaped cornea and no reversible scores within 7 days) therefore the test item is classified as “R41 Risk of serious damage to eyes”, according to the Annex VI of the Directive 67/548/EEC and ‘Category 1’ according to the CLP Regulation (EC) N° 1272-2008.
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