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Diss Factsheets
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EC number: 444-010-7 | CAS number: 82654-98-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.11.00 - 21.11.00
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: between 1.0 and 3.5 kg
- Housing: Individually housed in labelled cages with perforated floors and equipped with an automatic drinking system
- Diet (e.g. ad libitum): Standard laboratory rabbit diet, 100 gr. per day
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 days before the treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+-3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals of one sex
- Details on study design:
- TEST SITE
- Area of exposure: 150 square centimeters
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours and 24 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: hours
- Score:
- 24 - 72
- Max. score:
- 1.07
- Reversibility:
- fully reversible
- Remarks:
- within 7 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The scaliness, as observed after 7 days, was considered to be reversible skin reaction that resolves within the full study period of 21 days.
Reference
INDIVIDUAL SKIN IRRITATION SCORE:
Animal # | 1 | 2 | 3 | ||||||
Time after exposure | Erythema | Edema | Comments | Erythema | Edema | Comments | Erythema | Edema | Comments |
1 hour | Well defined | No edema | - | Well defined | No edema | - | Well defined | No edema | - |
24 hours | Well defined | Very slight | - | Well defined | Very slight | - | Well defined | Very slight | - |
48 hours | Very slight | Very slight | - | Very slight | Very slight | - | Very slight | Very slight | - |
72 hours | Very slight | No edema | r | Very slight | No edema | l | Very slight | No edema | l,r |
7 days | No erythema | No edema | l | No erythema | No edema | l | No erythema | No edema | l |
r: Erythema at the edges of the application-area
l: Scaliness
ANIMAL SPECIFICATIONS:
Animal n° | Sex | Age (weeks) | Body weight (gr) |
1 | Male | 7 -9 | 1488 |
2 | Male | 7 -9 | 1529 |
3 | Male | 7 -9 | 1545 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.09.2009 - 28.10.2009
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX. 1992. Protocol No. 47: HET-CAM Test
- Deviations:
- no
- Principles of method if other than guideline:
- To determine the potential irritancy using an alternative to the Draize methodology. The methodology was based on that described in INVITTOX. 1992. Protocol No. 47: HET-CAM Test.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Hen's eggs (white Leghorn)
- Vehicle:
- other: Mazola Corn Oil
- Controls:
- yes
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- Continuously for 5 minutes
- Number of animals or in vitro replicates:
- 24 eggs
- Irritation parameter:
- other: Classification of the irritating potential is according with the table on page 7 of the attached full study report
- Basis:
- other: See page 6 and 7 of the report
- Time point:
- other: 1 and 5 minutes after exposure
- Score:
- > 1 - < 5
- Max. score:
- 21
- Reversibility:
- other: Not applicable
- Interpretation of results:
- other: None to slight
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the threshold concentration of greater than 10% and the IS10% of 0, the irritating potential of CBE was determined as none to slight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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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