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EC number: 288-315-1 | CAS number: 85711-55-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Stock supply of healthy adult rabbits
- Number and Sex: 3 females
- Age on day of dosing (Day 1): 41 weeks
- Weight prior to dosing (Day 1): Minimum 3.95 kg, maximum 4.16 kg
- Housing: Individual housing in plastic cages with peforated floor
- Environmental enrichment: Small soft white untreated wood blocks
- Diet : Standard laboratory rabbit diet (125 g/animal/day). In addition, dietary supplement of hay
replaced by a supplement of wholemeal bread as from 2 days prior to dose instillation.
- Water: Drinking water, ad libitum
- Acclimation period: 29 or 30 weeks prior to study start under laboratory conditions.
Routine analysis of the batch of diet used for nutrients, possible contaminants and microorganisms and of the drinking water were conducted or available at the testing facility.
ENVIRONMENTAL CONDITIONS
Air conditioned animal room set at:
- Temperature (°C): 18 ± 2°C
- Relative Humidity (%): 40 to 70%
- Photoperiod: 12 hrs artificial light per 24 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of undiluted test substance was administered into the conjunctival sac of one eye per rabbit (right eye). The contralateral eye (left eye) remained untreated to serve as a control.
- Duration of treatment / exposure:
- The eyes were not rinsed after treatment, but in two of the three animals (#1 and #3) the treated eye was flushed with saline at 24 and 48 hours after treatment. For the other animal (#2) flushing of the eye with saline was not reported.
- Observation period (in vivo):
- 21 days for two animals, the other animal (# 3) was killed at 9 days after instillation for humane reasons.
- Number of animals or in vitro replicates:
- 3 adult female rabbits
- Details on study design:
- EYE EVALUATION:
Before treatment start both eyes of each animal were investigated to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.
One animal (the sentinel # 1) was initially treated and in the absence of a severe effect the remaining two animals were committed to the study.
Eyes were evaluated at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after test substance instillation adopting the numerical scoring system listed in Table 1 in the field below. The animal killed for humane reasons at 9 days after instillation (Day 10) had a final check for ocular lesions on this day. As from 24 h post treatment staining with fluorescein supported the recognition of corneal lesions.O
Equipment used for eye evaluation: Ophthalmoscope or pencil beam torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- as in one animal (# 3) area of pannus at 9 days after instillation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean over 4 time points
- Time point:
- other: 48 h, 72 h, 7 days, 9 days
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- as area of pannus at 9 days after instillation
- Remarks on result:
- other: Animal killed at 9 days after instillation for humane reasons
- Irritation parameter:
- other: Area of corneal opacity
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- other: Corneal ulceration or opacity were not evident
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 9 days in one animal (#3)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 9 days
- Remarks on result:
- other: Animal killed at 9 days after instillation for humane reasons
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 9 days in one animal (#3)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 9 days
- Remarks on result:
- other: Animal killed at 9 days after instillation for humane reasons.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: within 9 days in one animal (#3)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 9 days
- Remarks on result:
- other: Animal killed at 9 days after instillation for humane reasons
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: often mucoid discharge
- Irritant / corrosive response data:
- In two animals corneal opacity (grade 1 or 2), iritis (grade 1), conjunctival redness (grades 1, 2 and/or 3), chemosis (grades 1 to 2 in one animal and grades 1 to 4 in the other animal) and discharge (grades 1 to 3) were seen until 72 hours or 7 days after instillation. One of these animals was entirely free from ocular findings by 7 days after instillation the other animal by 14 days after instillation.
However, the third animal was more severely affected, in particular regarding corneal and conjunctival findings: Translucent and nacreous areas of corneal opacity were evident from 48 hours after instillation and nine days after instillation an area of pannus formation was apparent. Due to the irreversible nature of these corneal findings, this animal was humanely sacrificed immediately after the examination at nine days after instillation. In addition, an ulcer under the top eyelid was evident at nine days after instillation. - Other effects:
- Observation of the animals for defined behavioural criteria led to the conclusion that instillation of the test substance induced practically no initial pain response. Any other signs of systemic toxicity or ill health were not evident.
Signs of reaction to treatment comprised the head of all animals being held slightly to the right on the day of administration, the right periorbital area being sensitive to touch 24 hours after instillation in one animal (#2), and hairloss on the right upper eye lid in two animals (#1 and #3) nine days after instillation or from fourteen days after instillation.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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