Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 3, 1998-Nov. 19, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study done according to OECD guideline 204.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Sampling was done on test solutions on days 1 and 14 of the test. Samples were taken from the test solution both before treatment, and after 24 hrs of treatment.

Test solutions

Details on test solutions:
1 g/L of LAB was added to reconstituted water; this was stirred for 24 hours and then transferred to a separatory funnel and allowed to stand 4 hours.  The lower portion was slowly filtered (0.45 um HV Millipore) and used for testing and for dilutions (2:1 and 1:1).

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Source: YARA Tropical Fish
- Length at study initiation (length definition, mean, range and SD): 3 cm average
- Weight at study initiation (mean and range, SD): 0.27 g average
- Feeding during test
- Food type: Mangime SERA DISKUS
- Amount: 2% per initial fish weight
- Frequency: daily


ACCLIMATION
- Acclimation period: 14 days
- Health during acclimation (any mortality observed): no mortality after 1st 48 hrs

Study design

Test type:
semi-static
Total exposure duration:
14 d

Test conditions

Hardness:
246 mg/L CaCO3
Test temperature:
24.2 degree C
pH:
7.4
Dissolved oxygen:
8.0 mg/L
Nominal and measured concentrations:
Mean measured concentration: before treatment (0 hrs) 5.53, 6.64, and 10.18 ug/L
after treatment (24 hrs) 0.43, 1.37, and 2.68 ug/L
Nominal concentration: 0, 5, 6.5, and 10 ug/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Material, size, headspace, fill volume: 5 L
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates):
- Biomass loading rate: 0.54 g fish/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Ca/mg ratio: 4:1



OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light/8 hrs dark
- Light intensity: artificial light


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Daily observations were made of swimming behaviour, reaction to stimuli, discoloration, food intake, and mortality. All fish were weighed and measured before the test. Survivors were weighed at test termination.

Results and discussion

Effect concentrationsopen allclose all
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 10 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 10 µg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No effects were observed for the concentrations tested. Both the LOEC and NOEC were > 10 ug/L. A decrease in the test substance concentration was observed within 24 hours (day 1 and day 14), but the daily renewal of test solutions guaranteed the exposure to the test substance.

Any other information on results incl. tables

Body weight (mean)              

Concentration

0 (ug/L)

5 (ug/L)

7.5 (ug/L)

10 (ug/L)

Initial (g)

0.20

0.4

0.20

0.28

Final (g)

0.20

0.41

0.21

0.28

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 14-day NOEC for fish was > 10 ug/L.
Executive summary:

This study determined the long-term toxicity of the test substance to fish. Fish were exposed for 14 days to a water accommodated fraction of 0, 5, 6.5, and 10 ug/L of test substance. The test medium was renewed daily. Fish were monitored daily for toxicity during the study. No adverse effects were seen during the study period. The NOEC for fish is > 10 ug/L. The LC50 was > 10 ug/L/day.