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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24th April 2020 to 18th September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Physical appearance : Solid
Purity as per Certificate
of Analysis
: 60 -85% (No purity correction during dose
formulation preparation)
Total Organic Content
(TOC)
: 62.3 %
Batch No. : GRM193K01
Manufactured date : 19 July 2019
Expiry date : 03 September 2021
Physico-chemical
properties
: Density: 1.32 g/cm3 (23 °C)
Storage conditions : Ambient (+15 to +25ºC) - Analytical monitoring:
- yes
- Details on sampling:
- Stability of the test item in the test medium as well as analysis of test
concentrations was conducted using a validated analytical method. Method
validation, stability and recovery of test item was carried out at 1 and
50 mg/L test concentrations.
All the test concentrations along with the negative control and vehicle control
was analyzed for the test item concentration at the beginning and at the end
G19185_DAT Page 16/86
Copy No. 2/2
of test. For analysis, single composite sample was drawn from prepared test
concentrations and from the negative and vehicle control.
The criteria for acceptance of analysis results of test concentration were 80 to
120 % of nominal concentration with ≤ 20 % RSD of analyzed concentration.
The active ingredient concentration analysis showed that the per cent
agreement with nominal concentration of the samples of all test
concentrations analysed at the start and end of test were not within the range
of ± 20 % of the nominal concentration. The analysis of samples drawn at the
start of test was repeated using back up set. Hence, all test item
concentrations were recalculated by taking mean value from the analysis
results of start and end of the test. The calculated mean measured
concentrations are 1.30, 2.48, 8.02, 14.41 and 35.12 mg/L against the
nominal concentration of 2, 4, 8, 16 and 32 mg/L, respectively. - Vehicle:
- yes
- Details on test solutions:
- Bisphenol C Epoxy was insoluble in plain test medium and further with aid
of vehicles such as acetone, dimethyl sulfoxide (DMSO), dimethyl
formamide (DMF) and tetrahydrofuran (THF) test item stuck to side walls or
formed undissolved particles. Following OECD Guidance document No. 23,
it was attempted to prepare water soluble fraction (WSF) and water
accommodated fraction (WAF) at various concentration of 10, 50, 100, 1000
and 2000 mg/L by keeping the preparation under low energy stirring for 24 h
and 48 h. The test item was found to stick to the magnetic stirring pellet and
concentrated at the bottom of the vessel. Further, analysis of aqueous/filtered
samples found no promising recovery of test item.
However, test item formed a suspension with settleable solids at bottom when
it was mixed with test medium containing 0.01% tertiary butyl alcohol at
100 mg/L, as per OECD Guidance Document 23, Aqueous-Phase Aquatic
Toxicity Testing of Difficult Test Chemicals. Analysis of aqueous sample
showed around 38% recovery of test item. Hence, 0.01% tertiary butyl
alcohol was selected as vehicle to prepare the required test concentrations for
the test.
Extensive solubility work was conducted to identify an appropriate dose preparation method. Details of which can be found in the attached report. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna was used as test system as it is a recommended species in the
guideline. Daphnia were sourced from cultures present at Eurofins Advinus Limited, Bengaluru, INDIA.
The test medium in which the
daphnia were maintained was changed at least twice a week and they were
fed with the unicellular green alga, Chlorella vulgaris.
One day prior to the start of the treatment, about 25 adults were incubated in
approximately 2 L of reconstituted water. The following day, the young ones
hatched which were less than 24 hour old were collected and used in the tests. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Test temperature:
- Range Finding Test
18.6 to 19.1 oC
Definitive Test
19.1 to 19.8 oC - pH:
- Range Finding Test
7.61 to 7.83
Definitive Test
7.76 to 7.80 - Dissolved oxygen:
- Range Finding Test
6.3 to 7.0
Definitive Test
6.4 to 6.9 - Nominal and measured concentrations:
- Range Finding
Neonates of daphnia were tested for immobility in test concentrations of 0.01, 0.1, 1, 10 and 100 mg/L along with negative
control and vehicle control.
Definitive Test
The definitive test was carried out using nominal test concentrations of 2, 4, 8, 16 and 32 mg/L along with negative control and vehicle control.
The calculated mean measured concentrations are 1.30, 2.48, 8.02, 14.41 and 35.12 mg/L against the nominal concentration of 2, 4, 8, 16 and 32 mg/L, respectively. - Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.22 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 2.48 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- There was no immobilization of daphnia in the negative control, vehicle
control and at the mean measured test concentration of 1.30 mg/L at 24 and
48 hours of exposure. The immobilization of daphnia was 10, 80, 100 and
100% at 24 h and 30, 100, 100 and 100% at 48 h exposure at mean measured
concentrations of 2.48, 8.02, 14.41 and 35.12 mg/L, respectively.
The EC50 value for Bisphenol C Epoxy at 24 hours was 4.9223 mg/L with
fiducial limits at 95 per cent ranging from 3.89098 to 6.22697 based on
mean measured concentrations.
The EC50 value for Bisphenol C Epoxy at 48 hours was 3.2289 mg/L
based on mean measured concentrations.
The LOEC (Low Observed Effect Concentration) was 2.48 mg/L based on
mean measured concentrations.
The NOEC (No Observed Effect Concentration) was 1.30 mg/L based on
mean measured concentrations. - Validity criteria fulfilled:
- yes
- Conclusions:
- The EC50 value for Bisphenol C Epoxy at 48 hours was 3.2289 mg/L
based on mean measured concentrations.
The LOEC (Low Observed Effect Concentration) was 2.48 mg/L based on
mean measured concentrations.
The NOEC (No Observed Effect Concentration) was 1.30 mg/L based on
mean measured concentrations. - Executive summary:
The acute immobilization effect of the test item Bisphenol C Epoxy was
studied on Daphnia magna for 48 hours.
In definitive test, Daphnia magna less than 24 hours old were exposed to the
nominal concentrations of 2, 4, 8, 16 and 32 mg/L (respective mean measured
concentrations were 1.30, 2.48, 8.02, 14.41 and 35.12 mg/L) along with a
negative control and vehicle control. The number of daphnia immobilized
was recorded at 24 and 48 hours exposure.
There was no immobilization of daphnia in the negative control, vehicle
control and at the mean measured test concentration of 1.30 mg/L at 24 and
48 hours of exposure. The immobilization of daphnia was 10, 80, 100 and
100% at 24 h and 30, 100, 100 and 100% at 48 h exposure at mean measured
concentrations of 2.48, 8.02, 14.41 and 35.12 mg/L, respectively.
The stability test results concluded that the test item was stable in the test
medium at 48 h at nominal concentrations of 1 and 50 mg/L. The active
ingredient concentration analysis in all test concentrations showed that the
mean per cent agreement with nominal concentration was 52.2 to 123.275%
at the start of test and 59.338 to 119.622% at end of test (48 hour). Since the
analysis results of samples drawn at the start and end of test were out of the
acceptable limit (80 to 120 % of the nominal concentration with an RSD of <
20%) the nominal concentration of each test concentrations were recalculated
and presented as mean measured concentrations.
The EC50 value for Bisphenol C Epoxy at 48 hours was 3.2289 mg/L
based on mean measured concentrations.
The LOEC (Low Observed Effect Concentration) was 2.48 mg/L based on
mean measured concentrations.
The NOEC (No Observed Effect Concentration) was 1.30 mg/L based on
mean measured concentrations.
Reference
The EC50 value for Bisphenol C Epoxy at 48 hours was 3.2289 mg/L
based on mean measured concentrations.
The LOEC (Low Observed Effect Concentration) was 2.48 mg/L based on
mean measured concentrations.
The NOEC (No Observed Effect Concentration) was 1.30 mg/L based on
mean measured concentrations.
Description of key information
The EC50 value for Bisphenol C Epoxy at 48 hours was 3.2289 mg/L
based on mean measured concentrations.
The LOEC (Low Observed Effect Concentration) was 2.48 mg/L based on
mean measured concentrations.
The NOEC (No Observed Effect Concentration) was 1.30 mg/L based on
mean measured concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 3.229 mg/L
Additional information
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.
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