Registration Dossier
Registration Dossier
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EC number: 201-557-4 | CAS number: 84-74-2
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: flow-through study fulfilling guideline requirements / with analytics (cited in EU Risk Assessment Report) but only secondary source avaliable
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- secondary source
- Title:
- European Union Risk Assessment Report, dibutyl phthalate, CAS No: 84-74-2, EINECS No: 201-557-4
- Author:
- EU
- Year:
- 2 004
- Bibliographic source:
- European Chemicals Bureau
Materials and methods
- Principles of method if other than guideline:
- other: EG&G Bionomics Methods for Conducting flow-through Toxicity Tests with Freshwater Fish
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- - Name of test material (as cited in study report): di-n-butyl phthalate
- Analytical purity: 100 %
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- no
- Details on test solutions:
- - Method: A small volume of stock solution was added to 4 L of water. A combination of simultaeous mechanical mixing and ultrasonication was used to accomplish solubilization of the test substance. The resulting solution was transferred to 400 L water. The resulting solution was mixed with a magnetic drive micro pump for 12 to 15 hours and then dispensed into the flow-through aparatus. The flow-through solution was renewed every day. No vehicle was used.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Undissolved test substance was visible as a surface film in the aquaria with the two highest concentrations
Test organisms
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: Fathead minnow (Pimephales promelas)
- Source: EG&G, Bionomics, Wareham, Massachusetts (lot# 82A20)
- Length at study initiation (length definition, mean, range and SD): 3.6 cm (range 2.9 - 4.4 cm)
- Weight at study initiation (mean and range, SD): 0.38 g (0.20 Y - 0.70 g)
- Feeding during test: Withdrawal of food 2 days before and during exposure
ACCLIMATION
- Acclimation period: at least 2 weeks
- Health during acclimation (any mortality observed): less than 1 %
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 144 h
Test conditions
- Hardness:
- 20-26 mg/l as CaCO3
- Test temperature:
- 21 °C
- pH:
- 7.0-7.5
- Dissolved oxygen:
- 8.2-8.9
- Nominal and measured concentrations:
- 0, 0.69, 1.4, 2.8, 5.5, 11.0 mg/L (nominal)
<0.01, 0.32, 0.68, 1.7, 3.6, 7.6 mg/L (mean measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: All glass aquaria (39 x 20 x 25 cm) with 14 or 19 cm high drains, Volume of water: 11 or 15 L
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 0
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water, untreated, unchlorinated, aerated
- Alkalinity: pH 6.7 - 7.0
- Ca/mg ratio: 4 : 1
OTHER TEST CONDITIONS
- Photoperiod: 16 : 8 hours day-night regime
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
observations: mortality and symptoms after 0, 4, 24, 48, 72, and 96, 120 and 144 h
measurements: pH and oxygen content after 0, 24, 48, 72, 96, 120 and 144 h
TEST CONCENTRATIONS
Nominal test concentrations: see above - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 0.32 mg/L
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.92 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 0.71-1.2
- Details on results:
- - Behavioural abnormalities: Symptoms of intoxication: Tumbling (at 0.32, 0.68 and 1.7 mg/L), Apathy (at 0.68 and 1.7 mg/L).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
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