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EC number: - | CAS number: -
- 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
Surface tension
Administrative data
- Endpoint:
- surface tension
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because water solubility is below 1 mg/L at 20°C
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 24, 2020 to March 27, 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- GLP compliance:
- no
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- flask method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: LOT# 6252020
- Expiration date of the lot/batch: 9/30/2021
- Purity test date:10/21/2019 - Key result
- Water solubility:
- 138 µg/L
- Conc. based on:
- other:
- Remarks:
- For isomer ER1GP-IEM
- Loading of aqueous phase:
- 568.8 mg/L
- Incubation duration:
- >= 23 - <= 32 d
- Temp.:
- 22.4 °C
- pH:
- 7
- Remarks on result:
- other:
- Remarks:
- RSD = 1.3%
- Key result
- Water solubility:
- 7.95 µg/L
- Conc. based on:
- other:
- Remarks:
- For isomer ER2GP-IEM
- Loading of aqueous phase:
- 1 308.4 mg/L
- Incubation duration:
- >= 23 - <= 32 d
- Temp.:
- 22.4 °C
- pH:
- 7
- Remarks on result:
- other:
- Remarks:
- RSD = 12%
- Key result
- Water solubility:
- < 4.23 µg/L
- Conc. based on:
- other:
- Remarks:
- For isomer ER3GP-IEM
- Loading of aqueous phase:
- 1 196.4 mg/L
- Incubation duration:
- >= 23 - <= 32 d
- Temp.:
- 22.4 °C
- pH:
- 7
- Remarks on result:
- other:
- Remarks:
- average water solubility of 1.33 µg/L with RSD = 42%. The upper bound water solubility was calculated using overall average + SD×k-factor (95% confidence interval) of all the samples. The upper bound water solubility was reported due to the large method uncertainty of ±220%.
- Key result
- Water solubility:
- < 1.87 µg/L
- Conc. based on:
- other:
- Remarks:
- For Isomer ER4GP-IEM
- Loading of aqueous phase:
- 623.6 mg/L
- Incubation duration:
- >= 23 - <= 32 d
- Temp.:
- 22.4 °C
- pH:
- 7
- Remarks on result:
- other:
- Remarks:
- average measured water solubility of 0.583 µg/L with RSD = 31%. The upper bound water solubility was calculated using overall average + SD×k-factor (95% confidence interval) of all the samples. The upper bound water solubility was reported due to the large method uncertainty of ± 210%.
- Details on results:
- ERGP-IEM is a UVCB substance with four main isomeric mixtures. The water solubility was determined for ER1GP-IEM, ER2GP-IEM, ER3GP-IEM and ER4GP-IEM at incubation time 23, 28 and 32 days (Time point 1, 2, and 3).
For ER1GP-IEM, the average measured water solubilities were 139 µg/L (RSD% = 5.3%), 136 µg/L (RSD% = 2.4%), and 139 µg/L (RSD% = 1.0%) for Time Points 1, 2, and 3, respectively. All the intra-vial, intra-day, and inter-day ER1GP-IEM RSD results met the acceptance criteria of RSD <15%. The inter-day average measured water solubility of the ER1GP-IEM was 138 µg/L (RSD=1.3%, n=27).
For ER2GP-IEM, the average measured water solubilities were 7.08 µg/L (RSD% = 11%), 9.3 µg/L (RSD% = 31%), and 7.73 µg/L (RSD% = 15%) for Time Points 1, 2, and 3, respectively. The intra-vial, intra-day, and inter-day ER2GP-IEM RSD results were <15%, except for one intra-vial ER2GP-IEM result for day 32 with RSDs of 16%, and one intra-day ER2GP result for day 28 with RSDs of 31%. The inter-day average water solubility of the ER2GP-IEM was 7.95 µg/L (RSD=12%, n=27).
For ER3GP-IEM, the average measured water solubilities were 0.905 µg/L (RSD% = 72%), 1.95 µg/L (RSD% = 110%), and 1.12 µg/L (RSD% = 63%) for Time Points 1, 2, and 3, respectively. The inter-day average water solubility of the ER3GP-IEM was 1.33 µg/L (RSD=42%, n=27). However, the intra-vial, intra-day, and inter-day ER3GP-IEM RSD results did not meet the acceptance criteria of RSDs <15% with the range of 20%-110%, except for one intra-vial result on day 23. The water solubility of ER3GP-IEM is reported as upper bound water solubility due to large method uncertainty. The upper bound water solubility was calculated using overall average + SD×k-factor (95% confidence interval). The upper bound water solubility for ER3GP-IEM is <4.23 µg/L.
For ER4GP-IEM, the average measured water solubilities were 0.445 µg/L (RSD% = 74%), 0.788 µg/L (RSD% = 110%), and 0.516 µg/L (RSD% = 70%) for Time Points 1, 2, and 3, respectively. The inter-day average water solubility of the ER4GP-IEM was 0.583 µg/L (RSD=31%, n=27). However, the intra-vial, intra-day, and inter-day ER4GP RSD results did not meet the acceptance criteria of RSDs <15% with the range of 21%-160%, except for one intra-vial result on day 23. The water solubility of ER4GP-IEM is reported as upper bound water solubility due to large method uncertainty. The upper bound water solubility was calculated using overall average + SD×k-factor (95% confidence interval). The upper bound water solubility for ER4GP-IEM is < 1.87 µg/L.
The study discussed that the high RSDs of ER3GP-IEM and ER4GP-IEM may be due to the ERGP-IEM minor components (mass ratio < 10%), the test method unsuitability for complex mixtures at low water solubility concentrations. Although the variance in the ER3GP-IEM and ER4GP-IEM results fail to meet the acceptance criteria, the impact on the study data at these low concentrations is expected to have little impact on the solubility data of these constituents. - Conclusions:
- ERGP-IEM is a UVCB substance with four main isomeric mixtures. Under the conditions of this study, the average measured water solubilities for the four main isomers was 138 µg/L (RSD = 1.3%) for ER1GP-IEM, 7.95 µg/L (RSD = 12%) for ER2GP-IEM, < 4.23 µg/L for ER3GP-IEM and < 1.87 µg/L for ER4GP-IEM at 22.4 °C.
- Executive summary:
The water solubility of ERGP-IEM was determined at ambient temperature (22.4°C ± 0.9°C) using OPPTS 830.7840 “Water Solubility: Column Elution Method; Shake Flask Method” and OECD Guideline 105 “Water Solubility”.
Triplicate test vessels were prepared for each of the 3 time points (23, 28, and 32 incubation days). The ERGP-IEM test substance was added to Milli-Q™ water in visible excess of its solubility in the 30-mL glass jar at ambient temperature (22.4°C ± 0.9°C). The samples were slowly shaken at 30 RPM for up to 32 days to let the samples reach equilibrium at ambient temperature. The samples were removed from the shaker and triplicate aliquots from each test vessel were taken at each time point (at day 23, day 28 and day 32). All samples were analyzed using liquid chromatography/mass spectrometry (LC/MS).ERGP-IEM is a UVCB substance with four main isomeric mixtures. Under the conditions of this study, the average measured water solubilities for the four main isomers was 138 µg/L (RSD = 1.3%) for ER1GP-IEM, 7.95 µg/L (RSD = 12%) for ER2GP-IEM, < 4.23 µg/L for ER3GP-IEM and < 1.87 µg/L for ER4GP-IEM at 22.4 °C. The water solubilities forER3GP-IEM and ER4GP-IEM were reported asupper bound water solubility due tolarge method uncertainty. The upper bound water solubilitywas calculatedusing overall average + SD×k-factor (95% confidence interval).
This is a guideline study but not conducted under GLP. OPPTS 830.7840 is recommended for the water solubility determination of pure substances. Since ERGP-IEM is a mixture, it is not known what effect, if any, the different components will have on each individual component measured water solubility. Although it is expected to have little impact on the solubility data of these constituents, there are high RSDs and estimated measurement uncertainties for ER3GP-IEM and ER4GP-IEM. Therefore, it is considered reliable with restriction and a key study.
Table 1. Water solubility results of ERGP-IEM components
|
Solubility Conc. (µg/L)* |
Solubility Conc. (µg/L)* |
Solubility Conc. (µg/L)* |
Solubility Conc. (µg/L) |
|
Components |
Sample |
Time Point 1 (23 Day) |
Time Point 2 (28 Days) |
Time Point 3 (32 Days) |
Inter-day |
ER1GP-IEM |
1 |
144 (9.0) |
137 (9.9) |
140 (3.7) |
|
|
2 |
141 (2.6) |
139 (3.6) |
139 (11) |
|
|
3 |
130 (9.7) |
133 (3.4) |
138 (6.1) |
|
|
Intra-day Avg |
139 |
136 |
139 |
|
|
Intra-day RSD |
5.3 |
2.4 |
1.0 |
|
Inter-day Avg |
|
|
|
|
138 |
Inter-day RSD |
|
|
|
|
1.3 |
|
|
|
|
|
|
ER2GP-IEM |
1 |
6.83 (7.6) |
12.2 (15) |
8.20 (8.1) |
|
|
2 |
7.95 (9.6) |
7.68 (7.0) |
8.61 (16)** |
|
|
3 |
6.46 (3.8) |
7.17 (7.5) |
6.37 (8.0) |
|
|
Intra-day Avg |
7.08 |
9.03 |
7.73 |
|
|
Intra-day RSD |
11 |
31** |
15 |
|
Inter-day Avg |
|
|
|
|
7.95 |
Inter-day RSD |
|
|
|
|
12 |
|
|
|
|
|
|
ER3GP-IEM |
1 |
0.700 (1.3) |
4.36 (54)** |
1.58 (40)** |
|
2 |
1.63 (35)** |
0.944 (20)** |
1.48 (61)** |
||
|
3 |
0.385 (87)** |
0.551 (23)** |
0.313 (24)** |
|
|
Intra-day Avg |
0.905 |
1.95 |
1.12 |
|
|
Intra-day RSD |
72** |
110** |
63** |
|
Inter-day Avg |
|
|
|
|
1.33 |
Inter-day RSD |
|
|
|
|
42** |
|
|
|
|
|
|
ER4GP-IEM |
1 |
0.318 (7.9) |
1.81 (51)** |
0.764 (51)** |
|
|
2 |
0.817 (50)** |
0.351 (21)** |
0.685 (69)** |
|
|
3 |
0.199 (160)*** |
0.198 (38)** |
0.0991 (35)** |
|
|
Intra-day Avg |
0.445 |
0.788 |
0.516 |
|
|
Intra-day RSD |
74** |
110** |
70** |
|
Inter-day Avg |
|
|
|
|
0.583 |
Inter-day RSD |
|
|
|
|
31** |
*Average concentration of triplicate aliquots, values in parenthesis are %RSD of the triplicate aliquots
** RSD was > 15% and outside of acceptance criteria.
*** % RPD, one replicate was < LOQ and disregarded.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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