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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 945-909-1 | CAS number: 69415-01-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 JUNE 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Principles of method if other than guideline:
- • Groups of animals of a single sex are dosed in a stepwise procedure using the fixed doses of 300 and 2000 mg/kg.
• The initial dose level was selected on the basis of a sighting study as the dose expected to produce some signs of toxicity without causing severe toxic effects or mortality.
• Further groups of animals were dosed at higher dose depending on the presence or absence of the signs of toxicity or mortality. This procedure continues until the dose causing evident toxicity or no more than one death is identified or when no effects are seen at the highest dose or when deaths occur at the lowest dose. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene -2- yl)phenoxy] methyl} oxirane
- Molecular formula:
- C20 H18 Cl2 O4
- IUPAC Name:
- meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene -2- yl)phenoxy] methyl} oxirane
- Test material form:
- solid
- Details on test material:
- Batch GRM193K01
Manufactured 19.07.2019
exp date : 03.09.2021
Density 1.32 g/cm3 at 23°C
Constituent 1
- Specific details on test material used for the study:
-
Chemical Name (IUPAC): Reaction mass of meso-2- {[4-(2-{4-[(oxiran-2- yl)methoxy]phenyl}-1,1-dichloroethylidene-2 yl)phenoxy]methyl}oxirane and 2RS)-2-({4- 2- (4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1- dichloroethylidene-2- yl]phenoxy}methyl)oxirane
Related CAS No.: 69415-01-6
Physical appearance: Solid
Purity as per Certificate of Analysis: 60 -85% (No purity correction during dose formulation preparation)
Batch No.: GRM193K19
Manufactured date: 19. 07.2019
Expiry date:03.09.2021
Physico-chemical properties:Density : 1.32 g/cm3 (23 °C),pH: Not applicable
Storage conditions: Ambient (+15 to +25ºC)
Note: 1. Date of receipt of test item at test facility: 04 February 2020, 2. Test item code by test facility: H022-03
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Rats were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (13.7 air changes/hour). Environment: with temperature 21 to 25°C, relative humidity 65 to 68%, with 12 hours light and 12 hours dark cycle.
The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Doses:
- As there was no complete available toxicology information about test item. Hence, the study was initiated with starting dose of 300 mg/kg body weight as sighting study.
- No. of animals per sex per dose:
- 6
- Details on study design:
- Group and step Dose
(mg/kg) Concentration
(mg/mL) Volume of test item
suspension (mL) Test item
Quantity
G1
(Sighting study) 300 30 30 0.9 g
G2
(Sighting study) 2000 200 30 6.0 g
G2 (Main study) 2000 200 20 4.0 g
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Nil
- Clinical signs:
- other: G1 (Sighting study): There were no clinical signs and pre-terminal deaths. G2 (Sighting study): There were no clinical signs and pre-terminal deaths. G2 (Main study): There were no clinical signs and pre-terminal deaths.
- Gross pathology:
- There were no gross pathological changes at necropsy in the terminal sacrifice rats
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results of the present study, The LD50 of test item, Bisphenol C Epoxy is more than 2000 mg/kg body weight
- Executive summary:
The acute oral toxicity study with Bisphenol C Epoxy in Wistar rats was conducted to assess the toxicological profile of the testitem.
The dose formulation was prepared by using Corn-oil and administered as a single oral gavage to overnight fasted (16 to 18 hours) female rat (GI-sighting study) at the dose of 300 mg/kg body weight. The rat was normal and there was no pre terminal death observed.
As per scheme, the treatment was continued by dosing one female rat at the dose of 2000 mg/kg body weight (G2- sighting study). The rat was normal and there was no pre-terminal death observed.
Hence, as per Annexure 1 of the report the treatment was continued by dosing four additional female rats at the higher dose of 2000 mg/kg body weight (G2-main study). All rats were normal and there were no pre-terminal death observed.
The prepared dose formulation was administered at the dose volume of 10 mL/kg bodyweight.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8, 15 and death rats. Necropsy was performed for all the surviving rats. All surviving rats gained weight during experimental period. There were no gross pathological changes at necropsy..
Based on the results of the present study, the LD50 of the test item is >2000 mg/kg body weight.
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.