Registration Dossier

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:
1983
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:
2004
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): di-n-butyl phthalate
- Analytical purity: 100 %

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
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