Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 469-500-8 | CAS number: 857035-95-1
- 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:
- 19 september 2006 to 22 september 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Grimaud Frères, La Corbière, Roussay, France
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.682 kg
- Housing: Pajon cages
- Diet (e.g. ad libitum): 110 pelleted diet
- Water (e.g. ad libitum): water filtered by FG Millipore membrane
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- not applicable (single instillation without rinsing)
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- One.
- Details on study design:
- A single dose of 100 mg of the test item in its original form was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of test item. The right eye, which remained untreated,
served as control.
The eyes were not rinsed after administration of the test item.
SCORING SYSTEM:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
. no swelling 0
. any swelling above normal (includes nictitating membranes) 1
. obvious swelling with partial eversion of lids 2
. swelling with lids about half-closed 3
. swelling with lids more than half-closed 4
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
. blood vessels normal 0
. a number of blood vessels definitely hyperemic (injected) 1
. diffuse, crimson colour, individual vessels not easily discernible 2
. diffuse, beefy red 3
Discharge
. absence of discharge 0
. slight discharge (does not include small amounts normally found in
inner canthus) 1
. discharge with moistening of lids and hairs adjacent to lids 2
. discharge with moistening of lids and hairs on wide area around the eye 3
Iris lesions
. normal 0
. markedly deepened rugae, congestion, swelling, moderate circum-corneal
hyperemia, or injection, any of these or combination of any thereof, iris still
reacting to light (sluggish reaction is positive) 1
. no reaction to light, haemorrhage, gross destruction (any or all of these) 2
Corneal lesions
Degree of opacity (area most dense taken for reading)
. no ulceration or opacity 0
. scattered or diffuse areas of opacity (other than slight dulling or normal lustre),
details of iris clearly visible 1
. easily discernible translucent area, details of iris slightly obscured 2
. nacreous areas, no details of iris visible, size of pupil barely discernible 3
. opaque cornea, iris not discernible through the opacity 4
Area of opacity
. one quarter (or less) but not zero 1
. greater than one quarter but less than a half 2
. greater than one half but less than three quarters 3
. greater than three quarters up to whole area. 4
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: animal sacrificed for ethical reasons
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- other: animal sacrificed for ethical reasons
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- other: animal sacrificed for ethical reason
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: animal sacrificed for ethical reasons
- Irritant / corrosive response data:
- Severe irritant effects were observed.
- Other effects:
- On days 3 and 4, the eyelids of the animal were stuck together. In order to assess the ocular lesions, the eyelids were unstuck with 0.9% NaCl.
Clear to whitish purulent discharge was noted from day 1 until day 4.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was severely irritant when administered by ocular route to rabbits.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.