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EC number: 200-090-3 | CAS number: 51-34-3
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-08-03 to 2006-09-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The read-across justification is included as attachment to Iuclid section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- For determination of the test item concentrations, duplicate samples were taken from the freshly prepared test media of all test concentrations and the control at the first treatment period (Day 0), at a treatment period in the second week (Day 7), and at a treatment period in the last week (Day 17).To determine the maintenance of the test item concentrations during the test medium renewal periods, the following stability control samples were taken at the end of two treatment periods (on days 10 and 19):a) from the test media of all test concentrations and the control incubated during the renewal periods under the same conditions as the test itself, however without food particles and test animalsb) from the test media of all test concentrations and the control of the actual test (containing the food particles) by pouring together the contents of the test beakers after the end of the treatment periodAll samples were deep-frozen (at about -20°C) immediately after sampling. Based on pre-experiments (without GLP) for investigation of the storage stability, the test item is stable in the test water under these storage conditions. The concentrations of the test item hyoscine butylbromide were analyzed in the test media samples from the nominal concentrations of 32 and 100 mg/L, determined in the experiment as the NOEC and the LOEC. The test concentrations below the NOEC were not analyzed, because they were not relevant for the interpretation of the biological results.The samples from the start of the renewal periods were analyzed in duplicate. From the samples taken at the end of the renewal periods, one sample without food and one sample containing food were analyzed. From the control samples one of the duplicate samples was analyzed from each of all sampling dates.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: The test medium of the highest nominal test concentration of 100 mg/L was freshly prepared by dissolving 150 mg of the test item completely in 1500 ml of test water by intensive stirring for 10 minutes. The test medium of the highest test concentration was diluted with test water to prepare the test media of the lower test concentrations. The test media were freshly prepared just before introduction of the daphnids and just prior to each test medium renewal. The actual concentrations of the test item in the test media were analytically determined. The test concentrations were based on the results of a range finding test.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Species: Daphnia magna Straus
- Common name: water flea
- Source: was originally supplied by the University of Sheffield/UK in 1992
- Sex: female
- Age of parental stock (mean and range, SD): 14 days to 4 weeks
- Age at study initiation (mean and range, SD): 24 hours or less
- Feeding during test: yes
- Food type: green algae of the species Scenedesmus subspicatus and fish food suspension
- Amount of food: 0.1 - 0.25 mg TOC/daphnia (The amount was changed within this range depending on the growth stage of water fleas)
- Feeding frequency: three times a week
STOCK ANIMAL
- Each stock animal was maintained separately in a 100 mL glass beaker filled with about 80 mL culture medium and was transferred twice a week to fresh medium. The health of stock animals was frequently checked. No signs of stress were observed and the brood stock was healthy. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Hardness:
- 250 mg/L as CaCO3 (2.5 mmol/L)
- Test temperature:
- 18 - 22°C
- pH:
- 7.2 to 8.0
- Dissolved oxygen:
- at least 8.0 mg/L
- Nominal and measured concentrations:
- nominal: 1.0, 3.2, 10, 32 and 100 mg/L measured: 88 to 103% of the nominal value at the start of the test medium renewal periodsmeasured: 90 to 99% of the nominal value at the end of test medium renewal periods
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml glass beaker containing 80 mL of test medium
- Renewal rate of test solution (frequency/flow rate): every 48 hours (or 72 hours over week-ends)
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Volume per vessel: 80 ml/vessel
- Biomass loading rate: 10 animals individually at each test concentration and control
TEST MEDIUM / WATER PARAMETERS
- Total hardness (converted to CaCO3): 250 mg/L (2.5 mmol/L)
- Alkalinity: 0.9 mmol/L
- Water: Analytical grade salts and additives will be dissolved in purified water to obtain reconstituted M7 water.
- pH = 7.9
OTHER TEST CONDITIONS
- Photoperiod: 16/8 hour light/dark photo cycle
- Light intensity: 470 to 640 Lux
- Test temperature: 18-22°C continuously monitored
- Initial pH 7.9 +- 0.3
- Test water will be aerated prior to the start of the study until oxygen saturation; during the test the test media will not be aerated
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- The mortality and visible abnormalities of the test animals and the number of offspring will be recorded at least three times per week. Dead animals and offspring will be removed at the renewal of the test media.The NOEC and, if possible, the LOEC for reproduction rate will be evaluated by appropriate statistical tests (e. g. the multivariate Williams-test) after analysis of variance (ANOVA). If possible, also the EC10 and EC50 for inhibition of the reproduction rate at the end of the test will be calculated, e. g. by appropriate statistical tests as Probit analysis or moving average interpolation. - Reference substance (positive control):
- no
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: reproduction and mortality
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: reproduction and mortality
- Remarks on result:
- other: after 3 d exposure time
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 72 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Validity criteria fulfilled:
- yes
- Conclusions:
- A NOEC (21 d) value of 32 mg/L for reproduction was obtained from a study conducted according to OECD 211.
Reference
Number of surviving test animals
Exposure day | Nominal concentration of the test item (mg/L) | |||||
Control | 1.0 | 3.2 | 10 | 32 | 100 | |
0 | 10 | 10 | 10 | 10 | 10 | 10 |
1 | 10 | 10 | 10 | 10 | 10 | 6 |
3 | 10 | 10 | 10 | 10 | 10 | 6 |
5 | 10 | 10 | 10 | 10 | 10 | 0 |
7 | 10 | 10 | 10 | 10 | 10 | 0 |
10 | 10 | 10 | 10 | 10 | 10 | 0 |
12 | 10 | 10 | 10 | 10 | 10 | 0 |
14 | 10 | 10 | 10 | 10 | 10 | 0 |
17 | 10 | 10 | 10 | 10 | 10 | 0 |
19 | 9 | 10 | 10 | 10 | 10 | 0 |
21 | 9 | 10 | 10 | 10 | 10 | 0 |
% surviving on day 21 | 90 | 100 | 100 | 100 | 100 | 0 |
The total number of living young daphnids produced by all adults (cumulative values)
Exposure day | Nominal concentration of the test item (mg/L) | |||||
Control* | 1.0 | 3.2 | 10 | 32 | 100 | |
0 | 0 | 0 | 0 | 0 | 0 | 0 |
1 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | 169 | 163 | 174 | 183 | 133 | 0 |
12 | 292 | 426 | 539 | 461 | 390 | 0 |
14 | 366 | 442 | 539 | 519 | 463 | 0 |
17 | 549 | 595 | 636 | 682 | 661 | 0 |
19 | 841 | 993 | 1036 | 1022 | 999 | 0 |
21 | 881 | 1017 | 1037 | 1093 | 1051 | 0 |
% of control based on last exposure day | 100.0 | 115.4 | 117.7 | 124.1 | 119.3 | 0.0 |
The number of living offspring produced per surviving adult within 21 days of exposure
Replicate No. | Nominal concentration of the test item (mg/L) | |||||
Control | 1.0 | 3.2 | 10 | 32 | 100 | |
1 | 98 | 117 | 103 | 102 | 107 | * |
2 | 23** | 104 | 111 | 115 | 90 | * |
3 | 107 | 81 | 104 | 99 | 124 | * |
4 | 93 | 111 | 100 | 99 | 117 | * |
5 | 99 | 98 | 105 | 134 | 99 | * |
6 | * | 117 | 97 | 108 | 108 | * |
7 | 97 | 122 | 112 | 103 | 107 | * |
8 | 108 | 64 | 103 | 102 | 101 | * |
9 | 108 | 104 | 107 | 116 | 89 | * |
10 | 82 | 99 | 95 | 115 | 109 | * |
mean | 99.0 | 101.7 | 103.7 | 109.3 | 105.1 | - |
+-SD | 8.9 | 17.8 | 5.5 | 11.0 | 10.9 | - |
n | 8** | 10 | 10 | 10 | 10 | 0 |
CV% | 9.0 | 17.5 | 5.3 | 10.0 | 10.4 | - |
% of control | 100.0 | 102.7 | 104.7 | 110.4 | 106.2 | - |
CV%: coefficient of variation in % (SD/mean)*100%
*: test animal died during the test period
**: one of the 9 surviving daphnids had offspring only at day 10 and was then obviously no longer fertile. This daphnia was therefore excluded from this calculation
Description of key information
The read-across substance Hyoscine Butylbromide was assessed for its toxicological potential to Daphnia magna in a semi-static reproduction Test over 21 days according to OECD 211. Under this test conditions a NOEC 32 mg/L and a EC50 of 72 mg/L were determined.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 32 mg/L
Additional information
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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