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EC number: 403-360-0 | CAS number: 42405-40-3 BONTRON E-84; E-84
- 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:
- supporting study
- Study period:
- 3rd September 1985 to 6th September 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study is conducted by recognised test house, to experimental procedure in compliance with OECD Guideline 402 and Annex V of the 6th Amendment of the EEC Directive 79/831/EEC - Part B: Methods for the determination of toxicity B4 Skin Irritation. Full data set and rationale provided. GLP compliance not specified, although report is subject to Quality Assurance Procedure.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- and method B4, Annex V 79/831/EEC
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- No mention of GLP is made within the report; however the report was subject to Quality Assurance at the laboratory where the testing was conducted. As such, it is assumed that the principles of GLP were followed
Test material
- Reference substance name:
- Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- EC Number:
- 403-360-0
- EC Name:
- Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- Cas Number:
- 42405-40-3
- Molecular formula:
- C30H42O6Zn
- IUPAC Name:
- bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- Details on test material:
- - Name of test material (as cited in study report): Bontron E-84
- Substance type: Solid
- Physical state: White powder
- Analytical purity: Not specified
- Impurities (identity and concentrations): Not determined
- Lot/batch No.: No batch number is specified within the report, but the test substance is deemed equivalent based on history of manufacture and use.
- Stability under test conditions: Not determined
- Storage condition of test material: Ambient temperatures
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rabbits, Petersfield, Hampshire, England
- Age at study initiation: Approximately 9 to 10 weeks
- Weight at study initiation: 1.9 to 2.2 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: Exact period not specified, although stated that the rabbits selected for the study were all acclimated to the laboratory environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): Approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): give 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
IN-LIFE DATES: From: 3rd September 1985 To: 6th September 1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g was applied under a 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site on each animal
- Concentration (if solution): N/A
VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region, approximately 10cm square.
- % coverage: Not specified.
- Type of wrap if used: Occluded with "Elastoplast" elastic adhesive dressing for a 4 hour period
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Examination of the treated skin sites was made on Day 1 (approximately 30 minutes after removal of the treatment patches) and days 2, 3 and 4.
Grading and scoring of the dermal reactions were performed using the standard prescribed numerical scoring system for evaluating as follows:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptable): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema Formation:
No oedema: 0
Very slight oedema (barely perceptable): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Any other lesions not covered by the above were to be described within the study report.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- 0
- Basis:
- mean
- Time point:
- other: 96 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No response to the treatment was noted in any animal
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the four days observation period.
- Other effects:
- None
Any other information on results incl. tables
Rabbit Number and Sex |
E = Eyrthema O = OEdema |
Day |
|||
1* |
2 |
3 |
4 |
||
558F |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
559M |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
571F |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
* Approximately 30 minutes after removal of the dressing.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No effects were noted on the skin of the animals tested during the study period. Hence, it is deemed that the substance is not classified for irritation to the skin.
- Executive summary:
The dermal irritation of the substance was tested in vivo with three New Zealand White rabbits. Using a semi-occluded dressing, no reaction were noted during the study. The substance was concluded to be non-irritating.
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