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EC number: 201-126-0 | CAS number: 78-59-1
- 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
Endocrine disrupter testing in aquatic vertebrates – in vivo
Administrative data
- Endpoint:
- fish adult: (sub)lethal effects
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2020
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD TG 229 (Fish Short Term Reproduction Assay)
- Version / remarks:
- 2009
- Deviations:
- yes
- Remarks:
- These deficiencies/deviations do not have an impact on the interpretation of this study.
- GLP compliance:
- no
- Remarks:
- Signed and dated Quality Assurance claims statements were provided. A signed and dated GLP statement were not provided and appear to have been inadvertently omitted.
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: Liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Lot No.: 1136041301
- Purity: 98.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: stable
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
Test organisms
- Aquatic vertebrate type:
- fish
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: Fathead Minnow
- Source: A single laboratory stock. New England Bioassay, Inc., Manchester, Connecticut
- Life stage:
- Age at study initiation (mean and range, SD): 6 months
- Length at study initiation (length definition, mean, range and SD): not reported
- Weight at study initiation (mean and range, SD): 3.7 g (males), 1.8 g (females)
- Pre-exposure reproductive information >= 15 eggs / female / reproductive day / replicate
ACCLIMATION
- Acclimation period: 28 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: frozen brine shrimp (2.0 - 2.5 mL frozen adult brine shrimp, thawed)
- Feeding frequency during acclimation: 2 times /day
- Health during acclimation (any mortality observed): no mortalities was observed
FEEDING DURING TEST
- Food type: frozen brine shrimp
- Amount: 2.0 - 2.5 mL frozen adult brine shrimp, thawed)
- Frequency: 2 times /day
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs):
- Method of collection of fertilised eggs:
- Subsequent handling of eggs:
- Subsequent handling of juvenile fish:
POST-HATCH FEEDING
- Start date:
- Type/source of feed:
- Amount given:
- Frequency of feeding:
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
Test conditions
- Hardness:
- Mean: 68 (64 - 72) mg/l as CaCO3
- Test temperature:
- Min: 24.6 °C
Max: 25.4 °C
Mean: 25 °C - pH:
- 7.0 - 7.5
Mean: 7.3 - Dissolved oxygen:
- Mean: 7.4 mg/L ( 6.8 - 7.9 mg/L)
- Conductivity:
- 198 µmhos/cm
- Nominal and measured concentrations:
- Nominal: Cotrol, 0.8, 8 and 80 mg/l
Mean measured: Control, 0.748, 7.62 and 79.8 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria with silicone adhesive
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, 20 x 39 x 25 cm, solution depth - 13 cm / fill volume: 10 L
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): continuous-flow proportional diluter
- Renewal rate of test solution (frequency/flow rate): ca. 2.7 L/hr (equivalent to 6 volume replacements / day)
- No. of organisms per vessel: 6
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Upper Saginaw Bay of Lake Huron
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16 hrs light / 8 hrs dark
- Light intensity: 615 - 795 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
survival, fecundyity, fertilization success and clinical signs were observed daily. At test termination (Day 21), secondary sex characterization (body color, pattern, body shape), body weight, length, tubercle score, gonadal staging and histopathology and plasma vitellogenin.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 0.1
- Justification for using less concentrations than requested by guideline: reference study by Cairns and Nebker (see IUCLID Ch. 6.1.2)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.748 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- vitellogenin level
- Remarks on result:
- other:
- Remarks:
- females
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- > 79.8 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 7.62 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- fecundity
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 7.62 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- fertility
Any other information on results incl. tables
Table 1. Adult Fish Survival (21 days)
|
Males |
Females |
||||
Mean-Measured Test Concentration [mg/L] |
Number of organisms at the test initiation |
Number of organisms at the end oft he test |
% Survival |
Number of organisms at the test initiation |
Number of organisms at the end oft he test |
% Survival |
Control |
8 |
8 |
100 |
16 |
16 |
100 |
0.748 |
8 |
8 |
100 |
16 |
16 |
100 |
7.62 |
8 |
8 |
100 |
16 |
16 |
100 |
79.8 |
8 |
8 |
100 |
16 |
16 |
100 |
Table 2 Size of Fish at Test Termination
|
Mean Body Weight [g] |
Mean Length [mm] |
||
Mean-Measured Test Concentration [mg/L] |
Males |
Females |
Males |
Females |
Control |
3.62 |
1.79 |
52.5 |
43.4 |
0.748 |
4.10 |
1.65 |
54.3 |
42.9 |
7.62 |
3.79 |
1.73 |
54.3 |
43.8 |
79.8 |
2.76 |
1.35 |
52.4 |
42.8 |
Table 3. Fecundity and Fertilization Success.
Mean-Measured Test Concentration [mg/L] |
Mean Fecundity * |
Mean Fertilization Success [%]** |
Control |
31.6 |
98.4 |
0.748 |
32.9 |
97.8 |
7.62 |
29.9 |
98.0 |
79.8 |
1.80 |
29.3 |
* - Fecundity is calculated as the number of eggs per surviving female per reproductive day per replicate
** - Fertilization success (%) is calculated as the number of embryos divided by the number of eggs, multiplied by 100
Table 4. Nuptial Tubercle Score
Mean-Measured Test Concentration [mg/L] |
Mean Tubercle Score Males |
Mean Tubercle Score Females |
Control |
31 |
0 |
0.748 |
32 |
0 |
7.62 |
31 |
0 |
79.8 |
23 |
0 |
Table 5. Gonado-Somatic Index (GSI)
Mean-Measured Test Concentration [mg/L] |
Mean GSI * Males |
Difference to Control [%] |
Mean GSI* Females |
Difference to Control [%] |
Control |
1.25 |
0 |
13.06 |
0 |
0.748 |
1.25 |
-0.20 |
13.94 |
-0.66 |
7.62 |
1.30 |
4.20 |
14.44 |
-0.41 |
79.8 |
1.20 |
-4.4 |
9.36 |
-70.26 |
* - Gonado-somatic index (%) is calculated as gonad weight (to the nearest 0.1 mg) / body weight (mg) x 100
Table 6. Gonadal Staging.
Mean-Measured Test Concentration [mg/L] |
Median Stage Males |
Median Stage Females |
Control |
2 |
3 |
0.748 |
2 |
3 |
7.62 |
2 |
3 |
79.8 |
2 |
3 |
Table 7.Plasma Vitellogenin
Mean-Measured Test Concentration [mg/L] |
Mean Males [ng/mL plasma] |
Difference to Control [%] |
Mean Females [mg/mL plasma] |
Difference to Control [%] |
Control |
3480 |
0 |
154.25 x 106 |
0 |
0.748 |
5080 |
46.24 |
147.55 x 106 |
-4.33 |
7.62 |
1780 |
-48.79 |
86.55 x 106 |
-43.89 |
79.8 |
396 |
-88.63 |
35.2 x 106 |
-77.18 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
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