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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 479-880-7 | CAS number: 97042-18-7
- 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
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:
- 16 April to 23 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at a GLP accredited laboratory to internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Testing Guidelines Relating to New Chemical Substances (Notification No. 700 of KANPOGYO, No. 1039 of YAKUHATSU, No. 1014 of 61KIKYOKU, December 5, 1986)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- BPS-MAE
- IUPAC Name:
- BPS-MAE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): BPS-MAE
- Physical state: White powder
- Analytical purity: 99.2%
- Lot/batch No.: G130131
- Stability under test conditions: Confirmed stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD (SD) IGS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 6 weeks
- Weight at study initiation: males, 192.8 to 225.5 g; Females, 136.2 to 164.4 g.
- Fasting period before study: No
- Housing: 2 rats were housed together in a stainless-steel wire bottom cages (W260 x H200 x D380 mm).
- Diet: The rats were allowed free access to pellet diet (CRF-1, Oriental Yeast Co., Ltd., Tokyo, Japan).
- Water: The rats were provided with well water supplemented with sodium hypochlorite (approximately 2 ppm) ad libitum from an automatic dispenser.
- Acclimation period: males, 7 days; females, 9 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 to 27°C
- Humidity: 55 ± 10%
- Air changes: 13 to 15 air changes per hour.
- Photoperiod: 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): 1 or 2 times a week.
- Mixing appropriate amounts with (Type of food): pellets, CRF-1, Oriental Yeast Co., Ltd., Tokyo, Japan
- Storage temperature of food: low temperature.
VEHICLE
- Justification for use and choice of vehicle: CMC is a commonly used vehicle.
- Concentration in vehicle: 4, 20 and 100 mg/ml
- Amount of vehicle (if gavage): 0.5% solution. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
40 mg/kg
Basis:
other: Gavage
- Remarks:
- Doses / Concentrations:
200 mg/kg
Basis:
other: Gavage
- Remarks:
- Doses / Concentrations:
1000 mg/kg
Basis:
other: Gavage
- No. of animals per sex per dose:
- Male: 12 animals at 0 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 12 animals at 0 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The results of a former 7-Day Repeated Dose Toxicity Study of BPS-MAE in Rats [PPL Study No. P030158 (non-GLP), dose levels: 0, 50, 100, 500 and 1000 mg/kg, 3 males and females/group] did not reveal test substance-related changes in any test substance treatment group. Based on the above results, the high-dose level in this study was set at 1000 mg/kg, the maximum dose in the OECD testing
guidelines, and administration was expected to be possible for 28 days. The middle- and low-dose levels were set at 200 and 40 mglkg, respectively, as 5-fold dose decrements.
- Rationale for animal assignment (if not random): Group assignment was carried out by the stratified sequential randomization method on the basis of animal body weight on the day before the start of administration. - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- Cage side observations checked were; During the recovery period, all the animals were observed for clinical signs and mortality
once a day.
(1) Functional observation (detailed clinical observation)
Detailed clinical observation was conducted once before the start of administration (the day of group assignment) and once weekly during the administration (4 hours after administration) and recovery periods. Observation of animals outside their home cages was conducted by investigators holding an animal in their hands and observing it, and this was followed by observation in an open field for 2-5 minutes.
A. Cage-side observation
Posture, convulsions, stereotypies, bizarre behavior, tremors
B. Handheld observation
Handling reactivity, abnormal vocalization, tremor, twitching, convulsion, respiration, salivation, lacrimation, pupil size, exophthalmos, ocular or nasal secretions, skin, piloerection, fur, mucous membranes, incontinent urination, muscle tone, body temperature
C. Open-field observation
Arousal, abnormal gait, stereotypies, bizarre behavior, ptosis, diarrhea, defecation, urination
(2) Sensory reactivity to stimuli
Six males and 6 females with low animal numbers in each group underwent the following tests in week 4 of administration and week 2 of the recovery period: auditory reactivity, visual reactivity, touch response, pain response, righting reflex, and pupil response.
(3) Grip strength measurement
Six males and 6 females with low animal numbers in each group underwent grip strength measurement in week 4 of administration and week 2 of the recovery period. The grip strengths of the foreleg and hind leg were measured twice each using a dynamometer (CPU gauge: Model 9502A, Aikoh Engineering Co., Ltd.), and the mean values were calculated.
(4) Motor activity measurement
Six males and 6 females with low animal numbers in each group underwent motor activity measurement in week 4 of administration and week 2 of the recovery period. The animals' motor activity in a polycarbonate cage (W265xH185xD425 mm) was measured individually using a movement analyzer (SCANET SV-10, Toyo Industry Co., Ltd.). Data were collected at 10-minute intervals with measurement duration of 1 hour.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed clinical observation was conducted once before the start of administration (the day of group assignment) and once weekly during the administration (4 hours after administration) and recovery periods.
BODY WEIGHT: Yes
- Time schedule for examinations: The animals' body weights were measured on the day of the start of administration (day 1), and once a week thereafter. In addition, their body weights were measured on the day of the final administration and at the end of the recovery period. Their final body weights were measured before necropsy on the days of necropsy.
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
OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: When necropsy was conducted in the administration and recovery periods, about 2 mL of blood was collected from the posterior vena cava.
- Anaesthetic used for blood collection: Yes, sodium pentobarbital (30 mg!k:g),
- Animals fasted: Yes, for 18 hours or longer before blood sampling.
- How many animals: All animals sampled
- Parameters checked were; Leukocyte, Erythrocyte (RBC), Haemoglobin, Mean copuscular volume, Mean corpuscular haemoglobin, Mean corpuscular haemoglobin concentration, Platelet, Reticulocyte count, Differential leukocyte count, Prothrombin time and Activated partial prothrombin time.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: When necropsy was conducted in the administration and recovery periods, about 2 mL of blood was collected from the posterior vena cava.
- Animals fasted: Yes
- How many animals: All animals sampled
- Parameters checked in were;
Total protein (T.Protein) Biuret method
Albumin BeG method
A/G ratio Calculated from total protein and albumin
Total bilirubin (T.Bilirubin) Vanadate oxidation method
GOT UV-rate method
GPT UV-rate method
y-glutamyltranspeptidase (y-GTP) L-y~GIutamyl-3-hydroxymethyl-4-Nitroanilide reaction
Alkaline phosphatase (ALP) p-Nitrophenylphosphate reaction
Total cholesterol (T.Cholesterol) COD-HDAOS method
Triglycerides GPO-HDAOS method, glycerol-blanking method
Phospholipids Choline oxidase-DAOS method
Glucose Hexokinase-G-6-PDH method
Blood urea nitrogen (BUN) Urease-GLDH method
Creatinine Jaffe method
Inorganic phosphorus (IP) PNP-XOD method
Calcium (Ca) MXB method
URINALYSIS: Yes
- Time schedule for collection of urine: In week 4 of the administration period, 6 animals with small animal numbers in each group were housed individually in metabolic cages. Fresh urine samples were collected in the morning (before administration) under conditions of fasting and free access to water. Urinalysis was not carried out in week 2 of the recovery period, because the results in week 4 of the administration period revealed no test substance-related changes in any test substance administraition
group.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked were; pH, Protein, Glucose, Ketone bodyu, Bilirubin, Occult blood and Urobilinogen.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during detailed clinical observations,
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity, grip strength and motor activity. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; In the organ weight measurement, higher absolute and relative kidney weights were observed in the females in the 1000 mg/kg group, and these changes were considered to be related to administration of the test substance. They were considered to have little toxicological significance, however, since there was no histopathological change in the kidneys.
The higher absolute and relative kidney weights in the females in the 1000 mg/kg group had returned to normal at the end of the 14-day recovery period, suggesting good reversibility.
HISTOPATHOLOGY: Yes; Slight cellular infiltration of the lymphocytes in the prostate was observed in the males in the control group, slight focal fibrosis in the liver was observed in the females in the control group, and slight focal hemorrhage in the lungs was observed in the males in the 1000 mg/kg group. These findings were considered to be unrelated to administration of the test substance, however, since they were
observed in the control group or were spontaneous changes observed in normal rats.
Examination revealed no histopathlogical abnormality of the kidneys in the females in the 200 mg/kg group, in which a higher relative kidney weight was seen.
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):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weight measurement revealed higher absolute and relative kidney weights in the females in the 1000 mg/kg group.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Clinical observations:
There were no treatment-related deaths or other differences from control for other parameters measured, including clinical appearance, body weight, food and water consumption that were considered to be related to treatment.
There were no differences or abnormalities noted in the animals during the functional observation tests, and assessment of sensory reactivity to stimuli, grip strength and of motor activity, respectively.
Laboratory findings:
Hematology revealed statistically significant shortened activated partial thromboplastin time in males treated at 200 and 1000 mg/kg bw/d and in females at 40 mg/kg bw/d, in addition in males increased MCV and MCH at 40 mg/kg bw/d. At the end of recovery a lower basophils count was observed for the 1000 mg/kg bw/d males.
There were no test substance-related effects on clinical biochemistry and urinalysis data which could be considered of biological significance.
Effects in organs:
At 1000 mg/kg bw/d female rats showed an increase in both absolute and relative kidney weight when compared with controls. A higher relative kidney weight was observed in males at 200 mg/kg bw/d. At the end of recovery a higher absolute spleen weight and a lower relative kidney weight were observed in females at 1000 mg/kg bw/d.
No macroscopic or microscopic findings attributed to administration of the test substance were noted.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: clinical signs
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: clinical signs
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the above results, the no-observed-effect level (NOEL) under the conditions of this study was considered to be greater than 1000 mg/kg/day for males and 200 mg/kg/day for females. Good recovery from these changes was observed.
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.