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EC number: 946-565-5 | 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The rationale to read across the data is attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 8 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 1.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- number hatched
- Remarks:
- Embryonic survival
- Key result
- Duration:
- 33 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 1.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- adult mortality
- Remarks:
- Post-hatch mortality
- Key result
- Duration:
- 33 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.61 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- morphology
- Remarks:
- Malformation of caudal fin
- Key result
- Duration:
- 33 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.61 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- other: Growth based on length and weight
- Key result
- Duration:
- 33 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.8 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- weight
- Remarks on result:
- other: 95% confidence interval: 0.46 - 1.0 mg solids/L
- Key result
- Duration:
- 33 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.79 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: Test substance corrected for water content (specified in report as "solids")
- Basis for effect:
- length
- Remarks on result:
- other: 95% confidence interval: 0.64 - 1.0 mg solids/L
- Details on results:
- - Measured concentrations: Analyses of samples taken at the start of the test showed that the measured concentrations were generally in agreement with the target concentrations, i.e. were at 97-119% relative to the target concentrations. The analyses of the samples taken on Days 7 to 33 showed lower measured concentrations ranging at 35-131% relative to the target concentrations. Consequently, samples taken from the stock solutions were taken on Days 14, 21, 28 and 33. The concentrations measured in these samples were at 94-126% of the expected concentrations and thus indicated proper preparation of stock solutions. The reason for the lower measured concentrations is not known, but the observed build-up of microbial biomass could be responsible for this. The effect parameters were thus based on mean measured concentrations, see Table 1 in 'Any other information on results'. It should be noted that small responses were measured in the samples taken from the control group. Those were, however, at the level of the observed carry-over within the analytical system and thus judged to not originate from a contamination of the control group.
- See Table 3 in 'Any other information on results' for all effect parameters.
- Embryonic survival: 99% survival in control. Hatching started on Day 3 and was completed by Day 8 of exposure. Hatchability ranged from 90 to 100% and was generally not treatment related. On Day 5, the percentage of hatching was higher in the test item treated groups than in the control treatment.
- Larval survival and development: 94% larval survival in control. Post-hatch mortality at the end of the test in test item treated groups ranged from 5 to 16% and was not concentration-related. Statistical analyses confirmed that larval survival was not significantly affected up to and including 1.6 mg solids/L (NOEC). In the highest test concentration, all larvae showed malformation of the caudal fin, first observed at day 19 (pictures of the malformations compared with the control larvae are in the attached illustration). At lower test concentrations, a number of larvae showed abnormalities of the skeleton, the eyes or the swim bladder. Other individuals showed changes of coloration, or yolk-sac or cardiac oedemas. These observations were however singular and not test item related.
- Effects on larval growth: The test item caused a dose-related reduction in both body weight and length. At the highest concentration, the reduction of weight reached 38% while length was reduced by 18%. Statistically significant reduction of body weight as well as body length was observed at 1.6 mg solids/L. Hence, the NOEC for growth was 0.61 mg solids/L based on body weight as well as based on body length.
- All environmental paramenters remained within the limits prescribed by the study plan throughout the test. - Reported statistics and error estimates:
- Hatchability (embryonic survival):
- ECx values could not be calculated as ≥94% embryos hatched in all treatments.
- Differences between treatments and the control (Day 7): Chi²-2 x 2 table test with Bonferroni Correction (α=0.05, one-sided greater) after qualitative trend analysis by contrasts (monotonicity of concentration/response).
Larval survival:
- ECx values could not be calculated as ≤10% larvae died in any of the test concentrations compared to the control group.
- Differences between treatments and the control: Chi²-2 x 2 table test with Bonferroni Correction (α=0.05, one-sided greater) after qualitative trend analysis by contrasts (monotonicity of concentration/response).
Body length and body weight:
- ECx values: Probit analysis.
- Data distribution: Shapiro-Wilk´s Test
- Homogeneity of variance: Levene´s Test (with Residuals)
- NOEC: Williams Multiple Sequential t-test Procedure (α=0.05, one-sided smaller) after trend analysis by contrasts (monotonicity of concentration/response).
All analyses were performed with ToxRat Professional 3.2.1 (ToxRat Solutions® GmbH, Germany). - Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria.
- Conclusions:
- In a flow-through fish eary-life stage study with Amphoacetates C8-C18 (mono-acetate form), embryonic and larval survival was not affected at concentrations up to and including 1.6 mg solids/L; EC10 values were >1.6 mg solids/L. Consistent malformations of the caudal fin were observed in the highest test concentration of 1.6 mg solids/L, and thus the NOEC was considered to be 0.61 mg solids/L. EC10 values for growth reduction based on weight and length were 0.80 and 0.79 mg solids/L, respectively. The NOEC based on weight and length was 0.61 mg solids/L. This result is read across to the registered substance.
- Executive summary:
A flow-through fish early-life stage toxicity test was performed in order to assess possible lethal and sub-lethal effects of Amphoacetates 8 -C18 (mono-acetate form) during the embryonic and early larval development of the fathead minnow (Pimephales promelas). The test item was a clear light yellow viscous liquid UVCB substance consisting of 39.6% solids in water. A correction factor of 2.525 was used to correct for the water content of the test item. Concentrations are expressed based on solids.
The study was conducted in accordance with OECD 210 and in compliance with GLP. Fertilized eggs were exposed to an untreated control and the test item at mean measured concentrations of 0.035, 0.090, 0.22, 0.61 and 1.6 mg solids/L (80 eggs per group, divided into four replicates).
Embryonic and larval survival was not affected at concentrations up to and including 1.6 mg solids/L; EC10 values were >1.6 mg solids/L. Consistent malformations of the caudal fin were observed in the highest test concentration of 1.6 mg solids/L, and thus the NOEC was considered to be 0.61 mg solids/L. EC10 values for growth reduction based on weight and length were 0.80 and 0.79 mg solids/L, respectively. The NOEC based on weight and length was 0.61 mg solids/L. This result is read across to the registered substance.
The study met all validity criteria and is considered valid without restriction.
Reference
Table 1: Target, Measured and Mean Measured Concentrations During the ELS Test
Target conc. (mg solids/L) |
Measured concentration (mg solids/L) |
Mean measured conc.(mg solids/L) |
|||||
Day 0 |
Day 7 |
Day 14 |
Day 21 |
Day 28 |
Day 33 |
||
0.050 |
0.058 |
0.034 |
0.039 |
0.029 |
0.020 |
0.031 |
0.035 |
0.013 |
0.14 |
0.098 |
0.10 |
0.069 |
0.070 |
0.061 |
0.090 |
0.31 |
0.34 |
0.25 |
0.28 |
0.15 |
0.18 |
0.15 |
0.22 |
0.78 |
0.76 |
0.60 |
0.50 |
0.48 |
0.27 |
1.0 |
0.61 |
2.0 |
2.4 |
1.7 |
1.6 |
1.6 |
1.4 |
1.2 |
1.6 |
Table 2: Survival of Fish Embryos and Larvae During the
Range-Finding Test
Target concentrations (mg solids/L) |
No. of eggs Day 0 |
Number of survivors (at nominal day) |
Total survival (%) |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|||
Control |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
|
0.05 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
90 |
|
0.50 |
10 |
9 |
9 |
9 |
8 |
8 |
8 |
8 |
80 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
100 |
|
5.0 |
10 |
7 |
6 |
6 |
6 |
6 |
3 |
2 |
20 |
10 |
7 |
6 |
6 |
6 |
5 |
1 |
1 |
10 |
Table 3: Effect parameters (mg solids/L)
Parameter |
|
Mean measured concentration (mg solids/L) |
|||
LOEC |
NOEC |
EC10 |
EC50 |
||
Embryonic survival |
Value(a) |
>1.6 |
≥1.6 |
>1.6 |
>1.6 |
Post-hatch survival |
Value(b) |
>1.6 |
≥1.6 |
>1.6 |
>1.6 |
Malformation of caudal fin |
Value(b) |
1.6 |
0.61 |
n.a. |
n.a. |
Growth (weight) |
Value(b) |
1.6 |
0.61 |
0.80 |
>1.6 |
lower 95%-cl |
|
|
0.46 |
* |
|
upper 95%-cl |
|
|
1.0 |
* |
|
Growth (length) |
Value(b) |
1.6 |
0.61 |
0.79 |
>1.6 |
lower 95%-cl |
|
|
0.64 |
* |
|
upper 95%-cl |
|
|
1.0 |
* |
(a)for Day 8 of exposure,(b)for Day 33 of exposure, cl: confidence limit, * no confidence intervals could be determined, n.a. – not applicable
Table 4: Percentage of Embryonic Survival at the End of Hatching (Day 8)
Mean measured concentration (mg solids/L) |
Total Introduced |
Hatched |
Not Hatched |
% Hatched |
Control |
80 |
79 |
1 |
99 |
0.035 |
80 |
80 |
0 |
100 |
0.090 |
80 |
75 |
5 |
94 |
0.22 |
80 |
80 |
0 |
100 |
0.61 |
80 |
76 |
4 |
95 |
1.6 |
80 |
76 |
4 |
95 |
Table 5: Post-Hatch Mortalityat the End of Exposure (Day 33)
Mean measured concentration (mg solids/L) |
Total* introduced |
Survived |
Dead |
% Post-hatch mortality |
Control |
79 |
74 |
5 |
6 |
0.035 |
80 |
67 |
13 |
16 |
0.090 |
75 |
71 |
4 |
5 |
0.22 |
80 |
72 |
8 |
10 |
0.61 |
76 |
67 |
9 |
12 |
1.6 |
76 |
66 |
10 |
13 |
*Total number of hatched larvae.
Table 6: Mean Body Weight and Body Weight Reduction atthe End of Exposure (day 33)
Mean measured concentration (mg solids/L) |
Mean |
Std. Dev. |
n |
%Reduction |
Control |
74.450 |
5.7356 |
4 |
|
0.035 |
73.850 |
4.9776 |
4 |
0.81 |
0.090 |
76.550 |
2.0469 |
4 |
-2.8 |
0.22 |
69.150 |
4.6658 |
4 |
7.1 |
0.61 |
74.475 |
8.9481 |
4 |
-0.034 |
1.6 |
46.025 |
4.9026 |
4 |
38 * |
* effect statistically significant
Table 7: Mean Body Length and Body Length Reduction atthe End of Exposure (Day 33)
Mean measured concentration (mg solids/L) |
Mean |
Std. Dev. |
n |
%Reduction |
Control |
21.21 |
0.395 |
4 |
|
0.035 |
21.29 |
0.335 |
4 |
-0.38 |
0.090 |
21.43 |
0.326 |
4 |
-1.0 |
0.22 |
20.48 |
0.268 |
4 |
3.5 |
0.61 |
21.26 |
0.826 |
4 |
-0.26 |
1.6 |
17.50 |
0.709 |
4 |
18 * |
* effect statistically significant
Description of key information
A flow-through fish early-life stage toxicity test was performed with a chemical analogue of the registered substance in order to assess possible lethal and sub-lethal effects during the embryonic and early larval development of the fathead minnow (Pimephales promelas). The test item was a clear light yellow viscous liquid UVCB substance consisting of 39.6% solids in water. A correction factor of 2.525 was used to correct for the water content of the test item. Concentrations are expressed based on solids.
The study was conducted in accordance with OECD 210 and in compliance with GLP. Fertilized eggs were exposed to an untreated control and the test item at mean measured concentrations of 0.035, 0.090, 0.22, 0.61 and 1.6 mg solids/L (80 eggs per group, divided into four replicates).
Embryonic and larval survival was not affected at concentrations up to and including 1.6 mg solids/L; EC10 values were >1.6 mg solids/L. Consistent malformations of the caudal fin were observed in the highest test concentration of 1.6 mg solids/L, and thus the NOEC was considered to be 0.61 mg solids/L. EC10 values for growth reduction based on weight and length were 0.80 and 0.79 mg solids/L, respectively. The NOEC for weight and length was 0.61 mg solids/L. This result is read across to the registered substance.
The study met all validity criteria and is considered valid without restriction.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 0.61 mg/L
Additional information
In the flow-through fish early-life stage toxicity test performed with a chemical analogue of the registered substance consistent malformations of the caudal fin were observed in the highest test concentration of 1.6 mg solids/L, and thus the NOEC was considered to be 0.61 mg solids/L. EC10 values for growth reduction based on weight and length were 0.80 and 0.79 mg solids/L, respectively. The NOEC for weight and length was 0.61 mg solids/L, based on analytically confirmed test substance corrected for water content (and specified in the report as “solids”). The NOEC based on malformations (0.61 mg solids/L) is read across and used as worst-case key value for chemical safety assessment.
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