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EC number: 286-272-3 | CAS number: 85203-81-2
- 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:
- 1996-11-25 to 1996-12-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexanoic acid, 2-ethyl-, zinc salt, basic
- EC Number:
- 286-272-3
- EC Name:
- Hexanoic acid, 2-ethyl-, zinc salt, basic
- Cas Number:
- 85203-81-2
- Molecular formula:
- C16H30O4Zn
- IUPAC Name:
- zinc(2+) bis(2-ethylhexanoate)
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institue, Someren, The Netherlands
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 1289 - 1599 g
- Housing: individually in cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands); approx. 100 g/day and hay (BMI, Helmond, The Netherlands) was provided once a week
- Water (ad libitum): tap-water diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Relative humidity: 50%
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance was instilled in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after instillation of the test substance (Exception: eyes of one animal were also examined daily from 21 days up to 29 days after instillation)
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
SCORING SYSTEM: according to the Draize scale
TOOL USED TO ASSESS SCORE:
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. When considered necessary, this procedure was repeated to assess recovery.
In case standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.
OBSERVATIONS:
- Mortality/viability: twice daily
- Toxicity: at least once daily
- Body weight: day of treatment (prior to instillation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 24 h: no opacity; epithelial damage max. 25% of cornea; white covered eyelids / 48 h: white covered eyelids/ 72 h: epithelial damage max. 25% of cornea; reduced elasticity of eyelids / 7d: epithelial damage 10% of cornea; pannus; neovascularisation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 24 h: redness of nictitating membrane / 48 h & 72 h: redness of eyelids & sclera / 7 d: redness of sclera
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 24, 48 & 72 h: chemosis of eyelids / 48 & 72 h: chemosis of nictitating membrane / 48 h, 72 h & 7 d: chemosis of sclera
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 h: white covered eyelids
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 24 h, 48 h, 72 h & 7d: redness of eyelids / 24 & 48 h: redness of nictitating membrane & sclera
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 24 h: chemosis of eyelids; 48 h: chemosis of nictitating membrane and sclera
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 24 h: no opacity; epithelial damage max. 25% of cornea; white covered eyelids / 48 h: white covered eyelids / 72 h: epithelial damage max. 25% of cornea / 7 d: epithelial damage max. 25% of cornea; eye lids stuck together & released by soaking with water
- Remarks on result:
- other: 14 d: epithelial damage 10% of cornea; pannus, neovascularisation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: 7 d grade 1 was observed, fully reversible on 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: 24 h, 48 h & 7 d: redness of eyelids / 48 h , 72 h, 7 d & 14 d: redness of sclera
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 24 h, 48 h & 72 h: chemosis of eyelids, nictitating membrane and sclera
- Irritant / corrosive response data:
- Two animals showed corneal injury consisting of opacity (maximum grade 1-2) and epithelial damage (maximum 25% of the corneal area). As a result of the corneal injury pannus, neovascularisation of the cornea, was apparent 7 days after instillation in one animal and 14 days after instillation in the second animal. The corneal injury had resolved within 14 days in the first animal and within 21 days in the second animal. No cornel injury was observed in the third animal. Iridic irritation grade 1 was observed in one animal after 1 hour, in the second animal after 1 and 24 hours and in the third animal after 1 hour and 7 days. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days in two animals and within 21 days in the third animal.
A white covering was observed on the eyelids of all animals 24 and/or 48 hours after instillation. Reduced elasticity of the eyelids was noted in one animal 72 hours after instillation. The eyelids of another animal were struck together, 7 days after instillation and were released by soaking with abundant water.
Unexpectedly, one animal, which was free of any ocular irritation after 14 days, showed signs of ocular irritation between 21 and 29 days after instillation. The irritation consisted of corneal injury (opacity, epithelial damage and pannus), iridic irritation and conjunctival irritation. Minimal discharge persisted after 29 days (termination of the study). This irritation, which showed a relative slow recovery, was considered not to be related to the test substance treatment but to have been caused by accident. The latter results were excluded from interpretation.
There was no evidence of ocular corrosion.
No staining of peri-ocular tissue by the test substance was observed. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is irritating to the eye.
According to 67/548/EC and subsequent regulations, the test substance is classified as an eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is classified as Category 2.
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