Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4-8 July, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test was performed according to standard guidelines and under GLP, test concentrations were considered to be stable based on other tests with this test material in which chemical analyses were performed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
and EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): GBS-5
- Physical state: white powder
- Composition of test material, percentage of components:
- Substance (incl impurities) 95.26% w/w
- Water 4.74% w/w
- Lot/batch No.: GLS 30P (see CoA in the report attached)
- Stability under test conditions: No information
- Storage condition of test material: room temperature over silica gel

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 2.00 g of test material was dispersed in dichlorinated tap water and the volume was adjusted to 20 L to give a 100 mg/L test concentration.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucester, UK
- Length at study initiation: 4.8 cm, SD = 0.2 cm
- Weight at study initiation: 1.56 g, SD = 0.18 g
- Method of breeding: No information
- Feeding during test: No

ACCLIMATION
- Acclimation period: acclimatized to test conditions from 27 June to 4 July 1994
- Acclimation conditions: same as test conditions
- Type and amount of food: Commercial trout pellets
- Feeding frequency: daily (feeding stopped 24 h prior to test)
- Health during acclimation (any mortality observed): No mortality observed in the 7 days prior to the test.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
100 mg/L as CaCO3
Test temperature:
14.0 °C
pH:
7.4 - 8.0
Dissolved oxygen:
9.8 - 9.9 mg O2/L
Nominal and measured concentrations:
No analyses were performed, therefore all concentrations mentioned are nominal.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass aquaria holfing 20 L of test media
- Aeration: yes, via narrow bore glass tubes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.78 g bw/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water
- Total organic carbon: 1.7 mg/L
- Metals: traces
- Pesticides: 0.03 mg/L
- Chlorine: 0.18 mg/L
- Alkalinity: 86 mg/L
- Ca/mg ratio: 62:10 (mg)
- Conductivity: 331 MICSM
- Culture medium different from test medium: No information

OTHER TEST CONDITIONS
- Adjustment of pH: No information
- Photoperiod: 16 hours
- Light intensity: No information

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality (absence of respiratory movement and response to a physical stimulation

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed in the range finding test, therefore it was decided to perform a limit test at 100 mg/L
Reference substance (positive control):
not specified

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 95.26 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
4.74% water
Basis for effect:
mortality
Details on results:
No details given on behaviour of the fish. No fish died throughout the test.
Reported statistics and error estimates:
No statistic evaluation possible because no mortality was observed throughout the test.

Any other information on results incl. tables

 

Mortality of rainbow trout exposed for 96h

 Nominal concentration (mg/L)  3h  6h  24h  48h  72h  96h
 Control 0

0

0 0 0
 100 0 0
 100 0 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
No mortality in the control; constant conditions were maintained; oxygen level was above 60% of the air saturation value; test concentrations were considered to be stable based on other tests with this test material in which chemical analyses were perform
Conclusions:
The test material is not toxic to fish.
Executive summary:

TEST MATERIAL : GBS-5
TEST SPECIES : Rainbow trout (Oncorhvnchus mykiss)
TEST TYPE : Acute toxicity. 96 h LC50.
TEST CONDITIONS : Semi-static test conditions according to OECD Guideline No. 203 referenced as Method C.1 of Commission Directive
92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The following LC50 values are based on nominal test substance concentrations
LC50-3h > 100 mg/L

LC50-6h > 100 mg/L

LC50-24h > 100 mg/L

LC50-48h > 100 mg/L

LC50-72h > 100 mg/L

LC50-96h > 100 mg/L
“No Observed Effect Concentration” (NOEC) 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.