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EC number: 921-820-3 | CAS number: -
- 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:
- from 1998-12-07 to 1998-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: this study has been conduced following an accepted OECD guideline and in compliance with the GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- COS 98091
- IUPAC Name:
- COS 98091
- Details on test material:
- White powder
this substance was coded in the laboratory un der the reference 98-4493
Storage: at ambient temperature and out of the light in a romm especially fitted out to that effect.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: New Zealand albino rabbits
Origin: JEGARD Supplier (22120 Yffiniac, France)
Weight: superior to 1.8 kg, the day before application of the substance
Number and sex: 3 males
Acclimatization: for at least 5 days before the beginning of the test
Identification: each animal was identified by auricular ring and corresponding number was written on a label put on its cage
Housing: animals were individually housed, in stainless steel cages on floor grid
the cages were placed in limited-access premises, under air-conditioned temperature (20 +/- 3°C) and controlled relative humidity (HR= 50 +/- 20%).
Renewal of the air: 10 cycles per hour
The artificial lighting ensured a sequence of 12 hours light, 12 hours dark
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco, delivered by COFNA (37018 Tours, France)
Drinking: tap water
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye is the control
- Amount / concentration applied:
- 0.1 g of the test substance in the cunjunctival sac of one eye of each animal.
- Duration of treatment / exposure:
- After one hour of retention, animals were put back in their cages.
- Observation period (in vivo):
- cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- A single animal was test was employed. then two additional animals were tested.
0.1 g of the test substance in the cunjunctival sac of one eye of each animal.
After one hour of retention, animals were put back in their cages.
Cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.
In adition to the observations of cunjunctivae, iris and cornea, any other lesions were recorded and fully described.
After the recording observations at 24 hours, the eyes of all rabbits were further axamined after the instillation of fluorescein and rinsing 30 seconds later with 5 mL of 0.9% NaCl. Fluorescein was used for the following readings till no anomally was observed on the cornea.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0.7
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 1.3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 1.3
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance COS 98091 was not classified among the subsatnce irritant to eyes.
- Executive summary:
The aim of the study was to assess qualitatively and quantitatively irrtancy or corrosion and the delay of appearence of the efects after single application of 0.1 g of test substance as such on eye in 3 rabbits.
The eye irritation reactions (redness and chemosis of cunjunctivae, iris and cornea lesions) were scored at 1 h, 24h, 48h, and 72h then 4 days after instillation.
The test substance was classified in accordance with the EEC 67/548 Directive and its successive amendements.
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