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EC number: 201-618-5 | CAS number: 85-60-9
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Feb 2018. Day 28 post-hatch (test end) was 05 Mar 2018. Total test duration was 32 days.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- OECD Guideline study conducted to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Samples (25 mL) from the control, solvent control and each test concentration were taken for analysis prior to egg addition and on Day 0 (pre-hatch) and Days 0, x, x and x (post-hatch). A single replicate from the controls and each test concentration were sampled on each occasion with replicates being sampled alternately
- Vehicle:
- yes
- Details on test solutions:
- Information provided by the Sponsor indicated that the water solubility of the test substance was <4 µg/L. Preliminary solubility work indicated that a colourless solution could be achieved at a concentration of 80 µg/L in treated mains water when spiked via an auxiliary solvent (dimethylformamide) at a solvent rate of 50 µL/L.
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- The Pimephales promelas eggs used in the early life stage test were obtained from the in-house breeding system (details maintained within the centrally held records). Viable fish eggs were obtained from breeding groups of Pimephales promelas. Prior to initiation of the test the stage of development was established. The eggs were added to the test system, typically before the first cleavage of the blastodisc or within 24 hours of fertilisation.
The breeding groups in the breeding system were held in a temperature-controlled room under artificial light (with a 16 hour light:8 hour dark photo-period with a ca 30 minute dawn/dusk period) in holding tanks appropriate to their size, under continuous water renewal (flow-through) conditions.
The breeding groups of Pimephales promelas were fed ad libitum using freshly hatched brine shrimp (Artemia salinis) nauplii and also with Tetramin® flake food, which was added to the holding tank in quantities dictated by the size of the fish. The food was not considered to contain contaminants likely to affect the outcome of the study. Uneaten food and debris was siphoned or cleaned from the tanks as required.
The water used was laboratory treated mains supply. The water was pumped to the laboratory through an activated carbon filter. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 32 d
- Hardness:
- 16.0 mg/l
- Test temperature:
- 15 deg C
- pH:
- 7.3
- Dissolved oxygen:
- Control: 94 – 97
Solvent control: 95 – 96
0.80: 95 – 97
1.6: 96 – 97
8.0: 94 – 96
16: 95
80: 95 – 96 - Salinity:
- Not applicable.
- Conductivity:
- 180 uS/cm
- Nominal and measured concentrations:
- Nominal test substance concentrations of 0.80, 2.6, 8.0, 26 and 80 µg/L.
- Details on test conditions:
- Based on the results of the range-finding test, the definitive test was conducted at nominal test substance concentrations of 0.80, 2.6, 8.0, 26 and 80 µg/L. Control and solvent control groups were also included.
The test was conducted using a flow-through design (continual renewal of the media).
A solvent stock solution of 1.6 mg/mL was prepared by dissolving ca 400 mg of test substance in 250 mL of dimethylformamide (DMF). Serial dilutions were prepared in DMF to give further solvent stock solutions of 0.52, 0.16, 0.052 and 0.016 mg/mL.
The 0.016, 0.052, 0.16, 0.52 and 1.6 mg/mL solvent stock solutions were each separately dosed at a rate of 0.06 mL/hour to a diluent flow rate of 20 ± 10% mL/min to give the 0.80, 2.6, 8.0, 2.6 and 80 µg/L test concentrations, respectively.
A solvent control was prepared in a similar manner by dosing solvent only at a rate of 0.06 mL/hour to a diluent flow rate of 20 ± 10% mL/min.
Four replicates were prepared for the solvent control and each test concentration.
A dilution water control was prepared by continuously delivering treated mains water only into the four control vessels.
Solvent stock solution usage and diluent flow rates were checked daily during the test. - Reference substance (positive control):
- no
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 80 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- number hatched
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 26 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Post hatch survival
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 26 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- Statistical analysis of the data was performed using the CETIS program v 1.8.6.8.
Hatching success and post-hatch survival are considered to be quantal data. Lengths and weights are considered to be continuous data.
The data (hatching success, post-hatch survival, lengths and weights) were shown to be normally distributed with equal variance.
The control and solvent control groups were compared using the Fisher Exact Test (hatching success and post-hatch survival) and Equal Variance t Two sample Test (lengths and weights).
No significant differences were observed in terms of post-hatch survival, lengths and weights however a significant difference was observed between the control and solvent control groups in terms of hatching success. As such, the test groups were compared to the solvent control group.
The hatching success data were analysed using the Dunnett Multiple Comparison Test. No significant differences were observed between the solvent control and test groups.
The post-hatch survival data were analysed using the Cochran-Armitage Trend Step-Down Test. A statistical outlier was observed in the 80 µg/L test group (Grubbs Extreme Value Test). Data were therefore analysed with and without the outlying replicate. Both analyses showed a significant difference between the solvent control and 80 µg/L test group.
The length and weight data were analysed using the Dunnett Multiple Comparison Test. No significant differences were observed between the solvent control and test groups in terms of wet weight. A statistical outlier replicate was observed in the 26 µg/L test group. Statistical analysis including all replicates showed a statistically significant difference between the 26 µg/L test group and the solvent control with no significant differences between the solvent control and remaining treatment groups including the 80 µg/L test group. Statistical analysis excluding the outlier replicate showed a significant difference between the solvent control and 80 µg/L test group. To confirm this result, the data from the solvent control and 80 µg/L only were analysed using the Equal Variance t Two sample Test. The result from this analysis showed a statistically significant difference between the solvent control and 80 µg/L test group. - Results with reference substance (positive control):
- Not applicable.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No significant differences were observed in terms of post-hatch survival, lengths and weights however a significant difference was observed between the control and solvent control groups in terms of hatching success. As such, the test groups were compared to the solvent control group.
It should be noted that the water solubility of the test substance at 20°C is < 4 μg/l. The effects noted in this study are above the limit of solubility of the test substance in water, and are based on statistical manipulation. It is considered that these effects are attributable to solvent effects and the magnification of the effects is caused by the action of the solvents rather than any effects from the test substance which would not be found at these levels within the environment. As such, the effect concentrations are considered to be subject to variability due to the low solubility in water and solvent and as such, the test substance is proposed to not be harmful at the limit of solubility in water to fish or aquatic organisms in general. - Executive summary:
No significant differences were observed in terms of post-hatch survival, lengths and weights however a significant difference was observed between the control and solvent control groups in terms of hatching success. As such, the test groups were compared to the solvent control group.
It should be noted that the water solubility of the test substance at 20°C is < 4 μg/l. The effects noted in this study are above the limit of solubility of the test substance in water, and are based on statistical manipulation. It is considered that these effects are attributable to solvent effects and the magnification of the effects is caused by the action of the solvents rather than any effects from the test substance which would not be found at these levels within the environment. As such, the effect concentrations are considered to be subject to variability due to the low solubility in water and solvent and as such, the test substance is proposed to not be harmful at the limit of solubility in water to fish or aquatic organisms in general.
Reference
Biological Data
Nominal concentration |
Hatching success (%) |
Day 28 Post-hatch survival (%) |
Mean total length (mm) |
Mean total weight (mg) |
Control |
99 |
94 |
22.5 |
98.6 |
Solvent control |
86 |
93 |
22.6 |
103.9 |
0.80 |
89 |
95 |
22.2 |
101.5 |
2.6 |
98 |
92 |
22.0 |
101.2 |
8.0 |
100 |
91 |
21.4 |
93.7 |
26 |
98 |
88 |
20.2 |
82.9 |
80 |
91 |
62 |
21.2 |
100.4 |
Chemical analysis
|
Measured concentration (µg/L) |
|||
Nominal concentration (µg/L) |
Day 0 |
Day 4 |
Day 4 |
Day 10 |
Control |
- |
- |
- |
- |
Solvent control |
- |
- |
- |
- |
0.80 |
0.224 |
0.290 |
0.380 |
0.985 |
2.6 |
0.626 |
0.838 |
0.672 |
2.09 |
8.0 |
0.767 |
2.03 |
3.00 |
7.89 |
26 |
7.81 |
4.56 |
3.46 |
17.0 |
80 |
14.4 |
14.5 |
21.6 |
22.2 |
– non
detected above LOQ (0.2 µg/L)
|
Measured concentration (µg/L) |
|||
Nominal concentration (µg/L) |
Day 18 |
Day 24 |
Day 28 |
GMM (µg/L) |
Control |
- |
- |
- |
- |
Solvent control |
- |
- |
- |
- |
0.80 |
0.730 |
0.667 |
0.817 |
0.50 |
2.6 |
2.22 |
1.45 |
2.08 |
1.3 |
8.0 |
4.20 |
4.27 |
12.9 |
3.6 |
26 |
14.4 |
11.3 |
23.3 |
9.7 |
80 |
26.5 |
20.0 |
49.0 |
22 |
– non
detected above LOQ (0.2 µg/L)
GMM = geometric mean measured concentration
Description of key information
The NOEC is greater than the water solubility for the substance.
Key value for chemical safety assessment
Additional information
No significant differences were observed in terms of post-hatch survival, lengths and weights however a significant difference was observed between the control and solvent control groups in terms of hatching success. As such, the test groups were compared to the solvent control group.
It should be noted that the water solubility of the test substance at 20°C is < 4 μg/l. The effects noted in this study are above the limit of solubility of the test substance in water, and are based on statistical manipulation. It is considered that these effects are attributable to solvent effects and the magnification of the effects is caused by the action of the solvents rather than any effects from the test substance which would not be found at these levels within the environment. As such, the effect concentrations are considered to be subject to variability due to the low solubility in water and solvent and as such, the test substance is proposed to not be harmful at the limit of solubility in water to fish or aquatic organisms in general.
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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