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EC number: 500-429-8 | CAS number: 159034-96-5
- 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
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- 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
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- Endpoint summary
- Stability
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- 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:
- This study was conducted between 20 December 2016 and 03 February 2017
- 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)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese notification, Yakushokuhatsu 0331 No.7, Heisei 23.03.29 Seikyoku No.5, Kanpokihatsu No.110331009, March 31, 2011; the latest revision, December 21, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name of the new chemical substance (by IUPAC nomenclature): 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine
Alternate name: THEMIS
CAS RN: 159034-96-5
Molecular weight: Mn:3,000,Mw:11,000
Purity (%) of the new chemical substance subjected to the study: 100.0
Lot number of the new chemical substance subjected to the study: 160715
Melting point: 120 to 140°C
Appearance at room temperature: powder, pale pink
Stability: Swell on exposure to water; Soften at greater than or equal to 100°C
Source: 1) Supplier: Ajinomoto Fine-Techno Co., Inc.; 2) Expiration date: July 20, 2017 - Analytical monitoring:
- yes
- Details on sampling:
- Frequency: Two sets (One set consists of a new sample of test solution at the time of preparation and an old sample of the same test solution immediately prior to renewal or at the end of exposure.)
Collection: (i) At the time of preparation: Collected from the middle layer of the vessel for measuring the test conditions of each test group.
(ii) At the time immediately prior to renewal and at the end of exposure: Collected from the middle layer of one vessel of each test group. - Vehicle:
- no
- Details on test solutions:
- Preparation of Test Solutions
A water-soluble fraction* (WSF) was used to expose the test species to the test substance because it was considered that this multi-component test substance was partially soluble in water.
Test concentrations:
Test group Loading rate*1 (mg/L)
Control –
Conc. 1 10
Conc. 2 18
Conc. 3 32
Conc. 4 56
Conc. 5*2 100
Separation factor: 1.8
*1: Ratio of test substance to water (in mg/L) used in the preparation of the WSF.
*2: The loading rate was the maximum concentration given in the Test Guideline. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- 1) Common name: Daphnia magna
2) Scientific name: Daphnia magna
3) Source: National Institute for Environmental Studies, Japan
4) Date of receipt: July 18, 1995 The daphnids have been maintained at the testing facility.
5) Growth stage: Juveniles less than 24-hour-old (female)
6) Culture conditions of the parent daphnids that produced the test juveniles:
Water: Cultured in dechlorinated water for 48 hours or more after rearing in Elendt M4 medium, a reconstituted water recommended in the Test Guideline.
Biomass loading: 1 daphnid or less/80 mL (25 daphnids or less/2 L)
Vessel: 2-L glass beaker
Temperature: 20±1℃
Dissolved oxygen concentration (D.O.): 60% or more of saturation
pH: 6.0-9.0
Light: Fluorescent light, 16-hour light (800 lux or less) / 8-hour dark
Culture period: 28 days or less
Feed: Chlorella vulgaris (unicellular green algae)
Feeding amount: 6 mg C (organic carbon)/2 L / day
Renewal of water in the culture vessel: The first renewal was performed within 5 days after the start of culturing; subsequently, 3 times per week.
Offspring removal: Removed on the day offspring were produced.
7) Procedure of collection of the loading daphnids (Juveniles less than 24-hour-old): Juveniles less than 24-hour-old (female) were used for the test. At the start of exposure, it was confirmed that the parent daphnids fulfilled the following conditions:
Week age: 2-4 weeks (Culture period: January 17, 2017 to February 1, 2017)
Mortality of parent daphnids: 20% or less during the 2-week period prior to the start of exposure
Abnormality: Not observed
Production of first brood: within 12 days - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- ≤ 250 mg CaCO3/L
- Test temperature:
- 20 ± 1℃
- pH:
- 6.0 - 9.0
- Dissolved oxygen:
- >3 mg/L
- Nominal and measured concentrations:
- Nominal (loading rate): 10, 18, 32, 56, 100 mg/L
Measured: 0.192, 0.326, 0.384, 0.630, 1.45 mg/L - Details on test conditions:
- Test Conditions
1) Duration: 48 hours
2) Exposure procedure: Semi-static (batchwise renewal of the test solutions at 24-hour exposure)
3) Volume of test solutions: 100 mL/vessel
4) Number of vessels: 4 vessels/test group
5) Number of loading daphnids: 20 daphnids/test group (5 daphnids/vessel)
6) Temperature: 20 ± 1°C
7) D.O.: 3 mg/L or more, not aerated
8) pH: 6.0–9.0 (variation range <1.5), not adjusted
9) Light: Fluorescent light, 16-hour light (800 lux or less) / 8-hour dark
10) Feeding: None
Results of Range-finding Test
A range-finding test was conducted at loading rates*1 below the upper limit concentration (100 mg/L) given in the Test Guideline. A water-accommodated fraction*2 (WAF) was used as a test solution because the test substance was multi-component test substance and partially soluble in water. The results are given below.
*1: Ratio of test substance to water (in mg/L) used in the preparation of the WAF.
*2: An aqueous fraction containing the dissolved and/or suspended and/or emulsified fraction of a multi-component substance or mixture.
Results of the range-finding test
Loading rate (mg/L) Immobility after 48-hour exposure (%) Concentration of test substance in test solutions (mg/L)
At the start of exposure 24 hours after the start of exposure
Control 0 - -
100 10 6.08 1.78
Number of loading daphnids: 10 daphnids/test group (5 daphnids/vessel, 2 replicates/test group)
Results of First Exposure (rejected)
Based on the results of the range-finding test, the definitive test was conducted. The loading rate and the results of the definitive test are given below.
Test group Loading rate (mg/L) Immobility after 48-hour exposure (%) The time-weighted mean of measured concentration of test substance in test solutions (mg/L)
Control - 0 -
Conc. 1*1 100 15 4.28
*1: Limit test at the loading rate which was the maximum concentration given in the Test Guideline
In Conc. 1, the percentage of immobilisation was 15%. Therefore, this exposure was not adopted. Re-exposure was conducted with the WSF because there was a possibility that the insoluble fraction physically affected the test species.
Test Procedure
The loaded daphnids were introduced into each test vessel using a glass pipette at the start of exposure. The water surface was covered with a Teflon sheet to prevent evaporation of the test solutions and volatilization of the test substance. After 24-hour exposure, daphnids were transferred to the newly prepared test solutions using a glass pipette (renewal). The test ended at 48-hour exposure. During the exposure, observations of the loaded daphnids, measurements of the test conditions and observations of test solutions were performed according to the following procedure:
1) Observation of the loaded daphnids
Frequency: 24-hour (before renewal) and 48-hour exposure.
Items: number of immobilised daphnids *1, other abnormal symptoms*2.
*1: Individuals that were unable to swim within 15 seconds after gentle agitation of the test vessel were considered immobile.
*2: Daphnids showing abnormal behavior or appearance (such as discoloration) and floating daphnids on the surface of the water were recorded, if any.
2) Measurement of test conditions and observation of test solutions
Frequency: Two sets
Samples: (i) At the time of preparation: The test solution in the vessel for measuring the test condition of each test group.
(ii) At the time immediately prior to renewal and at the end of exposure: The test solution in one vessel of each test group.
Items: Temperature, D.O., pH, and appearance of the test solution. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 0.63 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL0
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1.45 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mobility
- Details on results:
- Measurements of Test Conditions and Observations of Test Solutions
In all the test groups, the temperature of the test solutions was in the range of 20 ± 1°C, the D.O. values were 3 mg/L or more, and the pH values were 6.0–9.0 of which the variation was within the range of 1.5, fulfilling the test conditions. In the appearance of test solutions of all the test groups, no suspended substances, no floating substances and no precipitations were observed, and the color was colorless during exposure.
Observation of Loaded Daphnids
In the control, the percentage of immobilisation was 0% at the end of exposure, and no daphnids were observed floating on the surface of the water.
In Conc. 1-5, the percentage of immobilisation was 0, 5, 0, 0, and 5%, respectively, at the end of exposure. The immobilised daphnid in Conc. 2 was judged not to be affected by the test substance, because there was not a correlation between concentration and the response. Based on the results of the range-finding test and the rejected exposure, it was considered that the immobilised daphnid in Conc. 5 was affected by the test substance.
Median Effect Concentration (EC50) and Median Effect Loading Rate (EL50)
The 48-hour EC50 and EL50 are also given below.
48-hour EC50: >1.45 mg/L (95% confidence limits: not available)
48-hour EL50: >100 mg/L (95% confidence limits: not available)
Highest Concentration with 0% Immobility (EC0) and Highest Loading Rate with 0% Immobility (EL0), Lowest Concentration with 100% Immobility (EC100) and Lowest Loading Rate with 100% Immobility (EL100)
The EC0, EL0, EC100 and EL100 values at the end of exposure are given below.
48-hour EC0: 0.630 mg/L
48-hour EL0: 56 mg/L
48-hour EC100: not observed
48-hour EL100: not observed
Validity of the Test
This test is judged valid because the results satisfied the validity criteria. - Results with reference substance (positive control):
- Acute immobilisation tests of the reference substance (potassium dichromate, guaranteed reagent) have been conducted periodically (approximately every 6 months).
The 48-hour median effect concentration (EC50) values are described below.
Latest result:
0.75 mg/L (95% confidence limits: 0.67–0.83 mg/L)
Exposure period: January 12, 2017 to January 14, 2017
The EC50 of reference substance fell within the standard range defined by the testing facility (average of EC50 of reference substance in the past ± 5 times of the standard deviation).
Result since June 1998:
Average ± standard deviation: 0.72 ± 0.12 mg/L, n=38
(Minimum–maximum: 0.49–1.02 mg/L) - Validity criteria fulfilled:
- yes
- Conclusions:
- The result given below was calculated from the time-weighted mean of measured concentrations and loading rate.
48-hour median effect concentration (EC50): >1.45mg/L (95% confidence limits: not available)
48-hour median effect loading rate (EL50): >100mg/L (95% confidence limits: not available) - Executive summary:
The study was conducted in accordance with the test method relating to new chemical substances "Alga growth inhibition test, Daphniasp.acute immobilisation test, and fish acute toxicity test" (Japanese notification, Yakushokuhatsu 0331 No.7, Heisei 23.03.29 Seikyoku No.5, Kanpokihatsu No.110331009, March 31, 2011; the latest revision, December 21, 2015) and the OECD Guideline for Testing of Chemicals No.202 “Daphniasp.,Acute Immobilisation Test” (2004).
The test was conducted with Daphnia magna over a 48 -hour exposure period.
Based on the results of the preliminary test, the definitive test was carried out at loading rate of 10, 18, 32, 56 and 100 mg/L. A concurrent blank control was performed in parallel. 4 replicates were used with 5 daphnia for each replicate. The test was performed with a semi- static system over 48 hours.
Results
The result given below was calculated from the time-weighted mean of measured concentrations and loading rate.
48-hour median effect concentration (EC50): >1.45mg/L (95% confidence limits: not available)
48-hour median effect loading rate (EL50): >100mg/L (95% confidence limits: not available)
Reference
Table 1 The Number of Immobilised Daphnia magna (Percent Immobility)
Test Group
|
Loadinga Rate
|
Meanb Measured Concentration |
Cumulative Number of ImmobilisedDaphnia (PercentImmobility) |
|||
|
(mg/L) |
(mg/L) |
24 Hours |
48 Hours |
||
Control |
-- |
-- |
0 |
(0) |
0 |
(0) |
Conc.1 |
10 |
0.192 |
0 |
(0) |
0 |
(0) |
Conc.2 |
18 |
0.326 |
1 |
(5) |
1 |
(5) |
Conc.3 |
32 |
0.384 |
0 |
(0) |
0 |
(0) |
Conc.4 |
56 |
0.630 |
1 |
(5) |
0 |
(0) |
Conc.5 |
100 |
1.45 |
0 |
(0) |
1 |
(5) |
a: The ratio of test substance to water (in mg/L) used in the preparation of the WSF
b: Time-weighted mean
Table 2 Median Effect Concentration (EC50) and Median Effect Loading Rate (EL50)
(1) EC50
Exposure Period (Hours) |
EC50 (mg/L) |
95-Percent Confidence Limits (mg/L) |
Statistical Method
|
||
24 |
>1.45*1 |
|
-- |
|
-- |
48 |
>1.45*1 |
|
-- |
|
-- |
*1: The EC50 value and its 95% confidence limits could not be determined by statistical method because the immobility ofDaphniaat the maximum concentration level was less than 50%. Therefore, the EC50 value was given as an estimated concentration range.
(2) EL50
Exposure Period (Hours) |
EL50 (mg/L) |
95-Percent Confidence Limits (mg/L) |
Statistical Method
|
||
24 |
>100*2 |
|
-- |
|
-- |
48 |
>100*2 |
|
-- |
|
-- |
*2: The EL50 value and its 95% confidence limits could not be determined by statistical method because the immobility ofDaphniaat the maximum concentration level was less than 50%. Therefore, the EL50 value was given as an estimated concentration range
Table 3 Highest concentration with 0% immobility (EC0) and highest loading rate with 0% immobility (EL0), lowest concentration with 100% immobility (EC100) and lowest loading rate with 100% immobility (EL100)
(1) EC0 and EC100
Exposure Period (Hours) |
EC0 (mg/L) |
EC100 (mg/L) |
48 |
0.630 |
-- |
-- : Not observed
(2) EL0 and EL100
Exposure Period (Hours) |
EL0 (mg/L) |
EL100 (mg/L) |
48 |
56 |
-- |
-- : Not observed
Description of key information
Alga growth inhibition test was conducted based OECD 202.
The result given below was calculated from the time-weighted mean of measured concentrations and loading rate.
48-hour median effect concentration (EC50): >1.45 mg/L (95% confidence limits: not available)
48-hour median effect loading rate (EL50): >100 mg/L (95% confidence limits: not available)
Less than 50% immobilisation occured at loading levels up to 100 mg/L therefore an accurate EL50 could not determined however the EL50 must be greater than 100 mg/L (measured concentration 1.45 mg/L).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
The registered substance is insoluble with water solubility of 1mg/L at 20℃. The test results showed 48h EL50>100mg/L which indicating no hazard identified at highest loading rate. Therefore LC50=100mg/L is used for CSR for worst cases.
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