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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 428-970-4 | CAS number: 13595-25-0
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 April to 19 May 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been QA audited and has been conducted in the spirit of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Bisphenol-M
- IUPAC Name:
- Bisphenol-M
- Details on test material:
- - Name of test material (as cited in study report): Bisphenol-M
- Substance type: Monomer
- Physical state: Fine white crystals
- Analytical purity: 99.5%
- Lot/batch No.: 5426
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Laboratory supplier
- Weight at study initiation: 305 to 392 g
- Housing: Guinea-pigs were housed in high density polypropylene cages measuring 56 x 38 x 18 cm, with stainless steel grid floors and tops.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 55
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Freunds complete adjuvant for anterior sites and distilled water for middle and posterior sites.
- Concentration / amount:
- Intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freunds complete adjuvant for anterior sites and distilled water for middle and posterior sites.
- Concentration / amount:
- Intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 hours
- Test groups: 1
- Control group:
- Site: Shaven dorsa
- Frequency of applications: guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled water and the test site was covered by an occlusive dressing for 48 hours.
- Duration:
- Concentrations:guinea-pigs were subject to intradermal injections of Freunds Complete Adjuvant, 10% w/v Bisphenol-M in distilled water, and 10% w/v Bisphenol-M in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 50% w/v Bisphenol-M in distilled wate.
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: Day 8
- Exposure period: 48 hours
- Test groups:
- Control group: Yes
- Site: right and left flanks
- Concentrations:distilled water to the left flank and 50% w/v Bisphenol-M in -distilled water to the right flank.
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 10 %
Evidence of sensitisation of each challenge concentration:
Slight confluiding or moderate spotty erythema was found in 1
animal of the test group and in 3 animals from the control group.
Other observations:
The intradermal application of the preparations used in the
first phase of the induction caused moderate
erythema at all tested areas where FCA was used. After
injection of 10 % substance in distilled water or only distilled
water no skin changes were observed.
After the occlusive topical application of distilled water in
the animals of the control group and in the animals of the
test group after the 50 % substance treatment in distilled water
no skin reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.