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EC number: 701-333-0 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- Council Regulation (EC) No 440/2008, Annex Part C, C.1., May 30, 2008
OECD Guideline for Testing of Chemicals, No. 203, adopted 18 June 2019
OCSPP 850.1075 of the United States Environmental Protection Agency (EPA), October 2016
OECD guidance document No. 23 (ENV/JM/MONO(2000)6/REV1; 8 February 2019) - GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Chemical name: Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane
CAS No.: 17557-23-2
EC / List no.: 701-333-0 - Analytical monitoring:
- yes
- Details on sampling:
- Three samples were taken from the ecotoxicological medium of different concentration level.
Samples were properly diluted with ultrapure water.
Diluted samples were stored at 2 - 8 oC until analysis.
Dilution of the ecotoxicological medium samples of the Test Item
Nominal concentration Dilution factor Dilution scheme
Control 40 25 µL → 1 mL
10 mg/L 50 20 µL → 1 mL - Vehicle:
- no
- Details on test solutions:
- The test solution used in the test was prepared at each water renewal period by mechanical dispersion without using any solubilising agent, as the substance is water soluble.
An appropriate amount* of test item was dissolved in the dilution water (ISO medium) in order to obtain the nominal concentration of 10 mg/L at each water renewal period.
After the formulation procedure the test animals were immediately introduced into the test solutions at each water renewal period.
* weighted amounts:
1st renewal: 0.0102 g test item dissolved in 1020 mL ISO medium
2nd renewal: 0.0108 g test item dissolved in 1080 mL ISO medium
3rd renewal: 0.0108 g test item dissolved in 1080 mL ISO medium
4th renewal: 0.0104 g test item dissolved in 1040 mL ISO medium - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Species: Zebrafish (Danio rerio)
Origin: Toma István e.v.
Hungary, 2146 Mogyoród, Gödöllői u. 41/B.
Number of animals: There were 10 animals in the treated and control group respectively (no replicates were used).
Age and size of animals: Juveniles were used. The total body length of each fish used was within the range of 1-2 cm. The total body weight of the test animals per groups was recorded on the day 0 (at the start of the test). The loading of the test aquaria was calculated (g fish / liter test solution). The loading did not exceed 0.8 g/L.
Sex: Both female and male (were not separated).
Animal health: Fish were bred in a well-known fish farm, under disease- and parasite-controlled conditions. Apparently healthy animals were used in the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- ISO medium, prepared according to the recommendation of OECD guideline 203
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- The reconstituted water (ISO medium) has an approximate theoretical total hardness of 249 mg/L (as CaCO3), calculated based on the concentration of calcium and magnesium ions in ISO medium.
- Test temperature:
- Temperature: The measured temperatures were within a range of 22.6 – 23.4°C in the test aquariums (the maximum deviation did not exceed ± 1°C) during the test.
- pH:
- pH: The test was carried out without adjustment of pH. The measured pH values were in the range of 7.76 – 8.09 during the test.
- Dissolved oxygen:
- Oxygen Concentration: The dissolved oxygen concentration was in the range of
75.4 – 88.1 % of the air saturation value at the temperature used. Aeration of test solution or control was not necessary during the experiment. - Nominal and measured concentrations:
- measured
- Details on test conditions:
- Aquariums were kept during the test in a climate chamber with controlled environmental conditions. The water temperature, pH value and dissolved oxygen concentration were determined at the start and at the end of each water renewal period in the test concentration and in the control.
Test type: Semi-static test. Based on the analytical results obtained during the acute daphnia test (Study number: 555-202-6264) the test item was not expected to be stable for the duration of the experiment in ISO Medium, therefore a semi-static test was performed using 24-h water renewal periods.
Test Duration: 96 hours
Loading: The loading of the test aquaria did not exceed 0.8 g fish/L.
Temperature: The measured temperatures were within a range of 22.6 – 23.4°C in the test aquariums (the maximum deviation did not exceed ± 1°C) during the test.
Oxygen Concentration: The dissolved oxygen concentration was in the range of
75.4 – 88.1 % of the air saturation value at the temperature used. Aeration of test solution or control was not necessary during the experiment.
pH: The test was carried out without adjustment of pH. The measured pH values were in the range of 7.76 – 8.09 during the test.
Light: Photoperiod: 16 h light : 8 h dark; Intensity: 565 lux (measured at the start of the test)
Hardness: The reconstituted water (ISO medium) has an approximate theoretical total hardness of 249 mg/L (as CaCO3), calculated based on the concentration of calcium and magnesium ions in ISO medium.
Feeding: The fish were not fed during the test.
Test Units
Type and Size: Glass aquariums with appropriate size for holding the fish up to the loading of 0.8 g fish/L.
Identification: Each test unit was uniquely identified with study number and test group. - Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 7.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: no mortality or any sub-lethal effect were observed.
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 7.6 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: no mortality or any sub-lethal effect were observed.
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 7.6 mg/L
- 95% CI:
- >
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: no mortality or any sub-lethal effect were observed.
- Results with reference substance (positive control):
- no reference substance
- Reported statistics and error estimates:
- A limit test was carried out and no toxic effects were observed, therefore statistical analysis was not necessary.
- Sublethal observations / clinical signs:
No mortality or any sub-lethal effects were observed during the 96-h test period either in the exposure concentration of 7.6 mg/L or in the concurrent control.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this 96-hour acute toxicity test on Zebrafish (Danio rerio) the test item Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane had no toxic effect on fish at the exposure concentration of 7.6 mg/L, which is higher than the threshold concentration (EC50 of 7.488 mg/L, (see details in section 5.6.2 and 5.9.1)). Accordingly, the test item has no toxic effect on fish up to at least the threshold concentration of 7.488 mg/L.
Biological endpoints of the study are summarised in table below:
Summary of the biological endpoints (same as Table 1)
Endpoint Concentration
(based on measured concentrations)
96-h LC50 > 7.6 mg/L
(> 7.488 mg/L; threshold concentration)
96-h NOEC 7.6 mg/L
(> 7.488 mg/L; threshold concentration)
96-h LOEC > 7.6 mg/L
(> 7.488 mg/L; threshold concentration) - Executive summary:
Test item:
Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane
Test species:
Zebrafish (Danio rerio)
Dilution water:
ISO medium, prepared in the laboratory of TOXI-COOP ZRT.
Concentrations:
Limit test; using a single concentration of 10 mg/L (nominal) based on data obtained from acute Algae and Daphnia studies (threshold concentration; see section 5.6.2); untreated control ran in parallel.
The corresponding calculated exposure concentration (based on analytical measurements) was 7.6 mg/L.
Test design:
Fish were exposed to aqueous test media containing the test item for 96 hours in a semi-static test (24-h water renewal periods). Ten fish were exposed to the test concentration and control (no replicates were used). Fish were observed twice a day (in the morning and afternoon) during the exposure at approx. 2-3, 5-6, 24, 30, 48, 54, 72, 78 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen concentration and water temperature were carried out daily (at the start and end of each water renewal period).
Analytics:
For determination of the test item concentrations, samples were taken from the treatment and the control group at the start and at the end of each water renewal period. Concentrations were determined using LC-MS/MS.
Endpoints:
LC50, NOEC and LOEC for 96-h test period.
Statistics:
Statistical analysis was not necessary to determine test endpoints.
Results:
No mortality or any sub-lethal effects were observed during the 96-h test period either in the exposure concentration of 7.6 mg/L or in the concurrent control.
Accordingly, the 96-h NOEC was determined to be 7.6 mg/L.
The 96-h LC50 and LOEC were determined to be higher than 7.6 mg/L.
All validity criteria were met and therefore the study was considered to be fully valid
The biological endpoints are summarised below in Table 1.
Table 1: Summary of the biological endpoints
Endpoint
Concentration
(based on measured concentrations)96-h LC50
> 7.6 mg/L
(> 7.488 mg/L; threshold concentration)96-h NOEC
7.6 mg/L
(> 7.488 mg/L; threshold concentration)96-h LOEC
> 7.6 mg/L
(> 7.488 mg/L; threshold concentration)In this 96-hour acute toxicity test on Zebrafish (Danio rerio) the test item Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane had no toxic effect on fish at the exposure concentration of 7.6 mg/L, which is higher than the threshold concentration (EC50 of 7.488 mg/L, (see details in section 5.6.2 and 5.9.1)). Accordingly, the test item has no toxic effect on fish up to at least the threshold concentration of 7.488 mg/L.
Reference
Description of key information
Short-term toxicity to fish (LC50): NON-toxic (> 100 mg/L)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- > 7.6 mg/L
Additional information
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