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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 2009 to 5 January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to internationally recognised guideline
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- BPS-MAE
- IUPAC Name:
- BPS-MAE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: a well established supplier
- Age at study initiation: approximately 65 days
- Weight at study initiation: 226 to 250 g
- Housing: P2000 or 2154 cages with solid flooring. Wood shavings (Lignocel type 3-4 wood flakes) were supplied as bedding material. In the mating period, the animals were maintained in RB3 modified cages (gridded flooring), suspended over trays covered with absorbent paper which was changed at appropriate intervals
- Diet: free access to standard rodent diet
- Water: free access to potable water taken from the public supply
- Acclimation period: : five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not applicable (each animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated).
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 October 2009 (animal arrival) To: 26 November 2009 (necroscopy)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v carboxymethylcellulose sodium salt
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): not reported
- Concentration in vehicle: 0,10,50 &100 mg/ml
- Amount of vehicle (if gavage): 10ml
- Purity: 0.5% w/v carboxymethylcellulose sodium salt.
All formulations were prepared freshly each week and stored refrigerated (approximately 4°C) and allowed to reach room temperature before dosing. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Before treatment commenced, the suitability of the proposed mixing procedure was determined and specimen formulations were analysed to assess the homogeneity and stability of the test material in the liquid matrix. Specimen formulations were prepared at concentrations of 1.0 and 100 mg/mL.
Samples of each formulation (4 x 1 mL) prepared for administration in the first and last weeks of the dosing period were taken and two assays from each group were analysed for achieved concentration of the test substance. A representative sample of test formulation was accurately weighed and dissolved in a suitable volume of diluent. The extract was diluted using diluent to provide a solution containing BPS-MAE at an expected concentration within the range 2 μg/mL to 4 μg/mL. The concentration of BPS-MAE in the final solution was quantified by high performance liquid chromatography. - Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Length of cohabitation: 2 days
- Proof of pregnancy: vaginal plug and sperm in vaginal smear - Duration of treatment / exposure:
- Day 1 to Day 19 (after mating)
- Frequency of treatment:
- Once each day at approximately the same time each day
- Duration of test:
- 19 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10,50, 100 mg/mL
Basis:
nominal conc.
dose volume 10mL/kg
- No. of animals per sex per dose:
- 22 females at each dose level
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: results from a preliminary study, in which animals receiving the highest dose only, showed slightly low bodyweight gain following daily oral gavage administration from Day 1 to 19 of gestation. Embryo-fetal survival, growth and development were unaffected by treatment. It was considered that the same doses, 0, 100, 500 and 1000 mg/kg/day and the same treatment regimen was suitable for main study.
- Rationale for animal assignment (if not random): Females were allocated to group and cage position in sequence of mating, thus ensuring that animals mated on any one day were evenly distributed amongst the groups.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean diet consumption calculated as g food/animal/day for the periods 0-2; 3-5; 6-9; 10-13; 14-17; 18-19
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Any abnormality in the appearance or size of any organ and tissue was recorded. The gravid uterus, including ovaries, was weighed prior to dissection.
OTHER: All external features and orifices were examined visually + full macroscopic examination of the tissues. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: all per litter (external examination) - Statistics:
- Statistical analysis were applied where there was indication of possible meaningful intergroup differences. All statistical analyses were carried out using the individual animal (or litter) as the basic experimental unit.
Statistical tests used for bodyweight, food consumption, gravid uterus weight, corpora lutea, implantations, live young, placental, litter and fetal
weights data:
1) A parametric analysis was performed if Bartlett's test for variance homogeneity (Bartlett 1937) was not significant at the 1% level.
2) A non-parametric analysis was performed if Bartlett's test was still significant at the 1% level following both logarithmic and square-root transformations.
For gravid uterus weight, corpora lutea, implantations, live young, placental, litter and fetal weights data, if 75% of the data (across all groups) were the same value, Fisher’s Exact tests (Fisher 1973) were performed.
Pre/post implantation loss and sex ratio were analysed by generalised mixed linear model with binomial errors, a logit link function and litter as a random effect (Lipsitz et al 1991). Each treated group was compared to control using a Wald chi-square test.
For resorptions, each treated group was compared to control by exact Wilcoxon rank sum test (Wilcoxon 1945). - Indices:
- Mean numbers of corpora lutea, implantations, male, female and total live young, early, late and total resorptions, mean sex ratio (percentage male), or pre and post implantation loss.
- Historical control data:
- None reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No significant effects
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No significant effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- 1000 mg/kg/day test substance is the maternal no-observed effect-level (NOEL) and the fetal no-observed-adverse-effect-level (NOAEL).
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.