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EC number: 283-041-9 | CAS number: 84539-53-7
- 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:
- May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well reported study. Observation period 8 days instead of 21 days.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period of 8 days instead of 21 days; sex unknown
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- EC Number:
- 283-041-9
- EC Name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- Cas Number:
- 84539-53-7
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- non specified (UVCB substance)
- Details on test material:
- - Name of test material (as cited in study report): Bolikel FE
- Physical state: a brown/red crystaline powder
- Lot/batch No.: Batch No. 2
- Storage condition of test material: at ambient temperature, under dry conditions
- Other: received on February 27, 1987 (4 x 375 g)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: at least 3 months old
- Weight on arrival: 2.29-2.38 kg
- Weight at study initiation: 3.08-3.67 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): free access (to S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England)
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (range 15 - 23)
- Humidity (%): 55 (range 40 - 70)
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hours artificial light per day
IN-LIFE DATES: From: May 11, 1987 To: May 19, 1987
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g test material
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- Single application (the eyelids were gently held together for one second and then released. The left eye remained untreated).
- Observation period (in vivo):
- 8 days (1 hour, 24, 48 and 72 hours and on Day 8)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: see below (additionally an assessment was made for the pain response)
TOOL USED TO ASSESS SCORE: ophthalmoscope and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- No
- Other effects:
- No
Any other information on results incl. tables
Summary of ocular lesions
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3 |
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||||
1 |
1 |
2 |
3 |
8 |
14 |
||||||
504M |
Cornea Iris Redness Chemosis |
2 1 1 1 |
0 1 2 0 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
- - - - |
0 |
0.33 |
1.67 |
0.33 |
511M |
Cornea Iris Redness Chemosis |
0 1 2 0 |
0 0 2 0 |
0 0 2 0 |
0 0 1 0 |
0 0 0 0 |
- - - - |
0 |
0 |
1.67 |
0 |
512M |
Cornea Iris Redness Chemosis |
0 1 2 1 |
0 1 2 1 |
0 1 2 0 |
0 0 2 0 |
0 0 0 0 |
- - - - |
0 |
0.67 |
2 |
0.33 |
Mean all anim. |
0 |
0.33 |
1.78 |
0.22 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.
- Executive summary:
A study was conducted to assess the irritancy potential of Bolikel FE to the eye of three New Zealand Albino rabbits. The study was performed according to OECD Guideline 405 (Acute Eye Irritation/Corrosion) and also according to Good Laboratory Practice Standards.
A single application of 0.1 g of the test material to the right eye of the rabbit produced redness of the conjunctivae, slight chemosis and iridial congestion were observed amongst all three animals during the first 24 hours. Translucency of up to one-quarter of the cornea was also apparent in one rabbit at the one hour examination. Only injection of the conjunctival blood vessels was observed at the 72-hour examination and all ocular lesions had resolved by Day 8.
Based on the results of the present study, it was concluded that the test compound, Bolikel FE, induced a reversible very slight eye irritation. So the test material was a ‘non-irritant’ to the eye and therefore not classifiable according to OECD-GHS.
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