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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1987 - May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well reported study; 3 days of observation instead of 14 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- - sex of rabbits is unknown
- no initial and confirmatory test - 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: brown/red crystals
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, England
- Age at study initiation: 3 months old
- Weight at study initiation: 2.76 - 2.89 kg
- Housing: individually housed 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 6 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 of artificial light per day
IN-LIFE DATES: From: April 28, 1987 To: May 1, 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- other: moistened with 0.2 ml distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): not applicable (moistened with 0.2 ml distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days (1 hour, 24, 48 and 72 hours after patch removal)
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: gauze patch was 3 x 2 cm
- % coverage: no info
- Type of wrap if used: The rabbit was securely restrained by a technician. Two test sites (6 x 6 cm) were marked on either side of the clipped area of dorsum and moistened by direct application of 0.2 ml distilled water per test site. A single dose (0.5 g) was impregnated onto an unmedicated gauze patch (3 x 2 cm) and was held in place on the left test site by strips of Blenderm (3-M Company). The right test site, acting as a control, was covered by a similar semi-occlusive dressing but otherwise remained untreated. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressings were removed after four hours exposure. Where necessary, the treatment sites were gently washed with warm water and dried with paper towels to remove excessive amounts of test material adhering to the skin.
- Time after start of exposure: 4 hours
SCORING SYSTEM: see below
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h after patch removal
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 h after patch removal
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No other dermal irritation response was observed in any animal.
- Other effects:
- No.
Any other information on results incl. tables
Summary of dermal lesions on clipped and intact skin (following 4-h application).
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h |
Mean score oedema 24/48/72 h |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|||||
523M |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
524M |
Erythema/ eschar Oedema |
1 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
525M |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
Mean Group |
0 |
0 |
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 Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.
- Executive summary:
A primary dermal irritation study was conducted on three male white rabbits using test substance Bolikel FE. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal received 0.5 g test material. A single 4 -hour, semi-occluded application of the test material to the intact skin produced immediately after patch removal very slight erythema at the test site of one animal. This effect disappeared after 24 hours after patch removal. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that Bolikel FE induced practically no skin irritation, so the test material is classified as non-irritant to the skin. Reversibility of the slight skin effect in one animal occurs.
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