Registration Dossier

Administrative data

Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Sep 2005 - 05 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Qualifier:
according to
Guideline:
other: OECD 305
Principles of method if other than guideline:
longer exposure period (28 days)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 7, 14, 21, 26, 28
- Sample storage conditions before analysis: no storage
- Analysis: HPLC

Test solutions

Vehicle:
yes
Details on test solutions:
HCO-40: 10 g/L as solubiliser

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 6.6 g
Length: 8.3 cm
Lot: 050714c

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d

Test conditions

Test temperature:
24.6 - 25 °C
pH:
7.3-7.4
Dissolved oxygen:
saturated
Salinity:
According to guideline
Nominal and measured concentrations:
nominal concentration 0.5 mg/L:
analytically measured concentrations:
day 4: 0.199 mg/L
day 7: 0.196 mg/L;
day 14: 0.194 mg/L
day 21: 0.198 mg/L
day 28: 0.196 mg/L

nominal concentration 0.05 mg/L
analytically measured concentrations:
day 4: 0.0200 mg/L
day 7: 0.0202 mg/L
day 14: 0.0194 mg/L
day 21: 0.0201 mg/L
day 28: 0.0195 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of test organisms: no effects
- Behavioural abnormalities:no effects
- Observations on body length and weight:no effects
- Other biological observations: no effects
- Bound residues forming a plateau: no
- Mortality and/or behavioural abnormalities of control: no
- Loss of test substance during test period: no
- Results with vehicle control: no effects

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was > 0.2 mg/L and thus higher than the limit of water solubility.