Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study (with GLP and analytics)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phthalide
- Analytical purity: about 100%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
-Method: The test solution was prepared by adding the test item to the test media using an ultra-turrax without any further pre-treatment. Then, the fish were placed into the test aquaria.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish (Danio rerio)
- Source: Hoechst Marion Russel Germany, GmbH
- Age at study initiation: about 4 months
- Length at study initiation (length definition, mean, range): 2.8 cm (2.5 - 3.2 cm)
- Weight at study initiation (mean and range): 0.24 g (0.1-0.4 g)
- Feeding during test: Withdrawal of food 1 day before and during exposure

ACCLIMATION
- Acclimation period: about 10 days
- Health during acclimation (any mortality observed): mortality of 1% during last 14 days

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Test temperature:
22 °C
pH:
7.9-8.4
Dissolved oxygen:
4.5-9.1 mg/L
Nominal and measured concentrations:
nominal (mg/L): 0, 46.4, 100, 315, 464, 1000;
measured, after 1 hour (mg/L): below limit of detection, 42.5, 85.4, 205.0, 381.9, 773.3;
measured, after 96 hours (mg/L): below limit of detection, 39.2, 82.2, 190.3, 423.6, not determined.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: All glass aquaria (30 x 22 x 24 cm), Volume of water: 10 L
- No aeration
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.24 g fish/L test water


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Municipal water of the city of Frankenthal, not chlorinated and passed through a charcoal filter, aerated.
- pH about 8.0-8.6
- Ca/Mg ratio: (90 mg/L)/(10 mg/L)


OTHER TEST CONDITIONS
- Photoperiod: 16 : 8 hours day-night regime


EFFECT PARAMETERS MEASURED:
observations: mortality and symptoms after 1, 4, 24, 48, 72, and 96 h
measurements: pH, oxygen and temperature after 1, 24, 48, 72 and 96 h




Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
82 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 190 - < 424 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: Symptoms of intoxication: Narcotic-like state, apathy (oserved at concentrations of 190 mg/L and above).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes