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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 November 1996 - 13 Aug 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
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: Solid
- Analytical purity: 99.5%
- Purity test date: 27 January 1997
- Lot/batch No.: 681001
- Storage condition of test material: Room temperature (ca 15-25°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory supplier
- Housing: Polypropylene cages with stainless steel wire grid tops and bottoms.
- Diet: Rat and Mouse (Modified) No.1 SQC Expanded (Pelleted) Maintenance Diet was available to the animals ad libitum except during collection of urine samples where access was not allowed.
- Water: The animals had access to domestic mains water ad libitum except during collection of urine samples where access was not allowed.
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2
- Humidity (%): 50
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- High Viscosity, 0,5 %
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Formulations were prepared daily on the day of use in the study.
VEHICLE
- Concentration in vehicle: 1 - 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bodyweight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of formulations were undertaken with regards to concentration and homogeneity on triplicate samples from each formulation (including Control) immediately after preparation. Samples were taken from the formulations used on Days 1 and 22 of treatment and analysed in the Inveresk Product Chemistry Laboratory using Method No. 7634 developed under the provisions ofInveresk Project No. 376342.
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
10 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day Male: 5 animals at 10 mg/kg bw/day Male: 5 animals at 100 mg/kg bw/day Male: 5 animals at 1000 mg/kg bw/day Female: 5 animals at 0 mg/kg bw/day Female: 5 animals at 10 mg/kg bw/day Female: 5 animals at 100 mg/kg bw/day Female: 5 animals at 1000 mg/kg bw/day
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were selected, in agreement with the Sponsor, based on results obtained from a One Week Dose Range Finding Study in Rats with Administration by Gavage (Inveresk Project No. 453526) where no adverse effects of treatment at levels up to 1000 mg/kg/day were noted.
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: Twice weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: Yes, isofluorane
- Animals fasted: No
- How many animals: All
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No
- How many animals: All
URINALYSIS: No
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / No data
- Animals fasted: Yes / No / No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Organ weights and histology
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight differences in the group mean values for haematology and coagulation analysis were considered unrelated to treatment with Bisphenol-M.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Group mean Aspartate Aminotransferase and Alanine Aminotransferase were increased in males treated at 1000 mg/kg/day when compared to Control. Other slight differences in the group mean values were considered unrelated to treatment with Bisphenol-M.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
There were no premature decedents throughout the study. Soft faeces were noted for all animals treated at 1000 mg/kg/day following completion of the first day of treatment and generally persisted throughout the remainder of the treatment period. Animal 20, a male treated at 1000 mg/kg/day, showed agitated behaviour from Day 10 of treatment up until termination. Additionally, a reduction in body weight was noted for this animal throughout Days 13-17 of treatment. No other animal treated at this level showed a similar effect therefore this observation was considered not to be related to treatment with Bisphenol-M.
BODY WEIGHT AND WEIGHT GAIN
There were no effects on body weight performance/body weight gain throughout the treatment period at any level ofBisphenol-M which were considered to be related to treatment.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
FOOD EFFICIENCY
No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
OPHTHALMOSCOPIC EXAMINATION
No data
HAEMATOLOGY
Slight differences in the group mean values for haematology and coagulation analysis were considered unrelated to treatment with Bisphenol-M.
CLINICAL CHEMISTRY
Group mean Aspartate Aminotransferase and Alanine Aminotransferase were increased in males treated at 1000 mg.kg-1.day-l when compared to Control. Other slight differences in the group mean values for the remaining clinical chemistry parameters were considered unrelated to treatment with Bisphenol-M.
URINALYSIS
No data
NEUROBEHAVIOUR
No data
ORGAN WEIGHTS
Slight differences in the group mean organ weights for males and females were not considered to be related to treatment at any level ofBisphenol-M.
GROSS PATHOLOGY
Pelvic dilation ofthe right kidney was noted for one male and one female treated at 1000 mg/kg/day and additionally in one female treated at 10 mg/kg/day. This observation is often seen in rats of this strain and age at Inveresk therefore is not considered to be related to treatment with Bisphenol-M.
HISTOPATHOLOGY: NON-NEOPLASTIC
Histological findings were representative of the background pathology seen in rats of this age and strain at Inveresk.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Dosing Sprague-Dawley rats by gavage for 4 weeks with Bisphenol-M at dose levels up to 1000 mg/kg/day produced clinical effects only at 1000 mg/kg/day, apparent as soft faeces following the first day of treatment then generally throughout the remainder of the treatment period. There were no histological findings which correlated with the increase in Aspartate aminotransferase and Alanine aminotransferase noted at 1000 mg/kg/day.
There were no effects on body weight performance, food or water consumption, organ weights, necropsy or histological findings at levels up to 1000 mg/kg/day. Additionally no treatment related clinical observations or effects on laboratory investigation parameters were noted at 100 or 10 mg/kg/day .
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, it was considered that treatment with Bisphenol-M resulted in slight effects at 1000 mg/kg/day and no adverse effects of treatment at 100 or 10 mg/kg/day. Therefore Bisphenol-M is not classified.
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