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Long-term toxicity to fish

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Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2005-06-10 to 2006-08-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD 305 and METI Guideline: Concentration Test on Chemical Substances in Fish
Qualifier:
according to
Guideline:
other: OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
Qualifier:
according to
Guideline:
other: METI Guideline: Concentration Test on Chemical Substances in Fish
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 7, 14, 21, 26, 28
Vehicle:
yes
Details on test solutions:
According to guideline PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 20 (Sorbitan Monolaureate) - Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.3 and 0.03 mg/lDose 1: Test item: 0.03 mg/L , Vehicle: 1 mg/LDose 2: Test item: 0.003 mg/L , Vehicle: 2 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 2.46 +/- 0.30 gLength: 6.26 +/- 0.27 cmLot: 50111Acclimatisation: 07.04.2003 - 29.05.2003
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
250 g/L
Test temperature:
24.6 - 26.9 °C
pH:
6.5 - 7
Dissolved oxygen:
6.8 - 7.1
Nominal and measured concentrations:
nominal concentration 0.03 mg/L: analytically measured concentrations: day 0: 0.0285 mg/L; day 7: 0.0318 mg/L; day 14: 0.0301 mg/Lday 21: 0.0286 mg/Lday 25: 0.0287 mg/Lday 28: 0.0326 mg/Lnominal concentration 0.003 mg/Lanalytically measured concentrations:day 0: 0.00334 mg/Lday 7: 0.00256 mg/Lday 14: 0.00259 mg/Lday 21: 0.00319 mg/Lday 26: 0.00261 mg/Lday 28: 0.00271 mg/L
Details on test conditions:
After acclimatisation period, the fish (Cyprinus carpio) were transferred into the test media under flow through conditions. Exposure concentrations were analytically verified at days 0, 7, 14, 21, 25 and 28. The analytical values show that the nominal concentrations of 0.03 and 0.003 mg/L were maintained at about 100%, respectively. At days 0, 7, 14, 21, 25 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted with acetonitrile and n-hexane. The extract was analysed with HPLC.Due to the low bioaccumulation potential, no depuration phase was required.
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.03 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 0.03 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was > 0.03 mg/L and thus higher than the limit of water solubility.
Executive summary:

Purpose

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions. During the GLP compliant test the lethal and other effects in fish were determined during the exposure period of 28 days.

Study Design

The study was performed according to the OECD Guideline for Testing of Chemicals 305 (Bioconcentration: Flow-through Fish Test) adopted on June 14, 1996 using two test material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.03 and 0.003 mg/Lwere used in this study. The exposure was concentration was maintained using SPAN 20 as solubiliser. The concentrations were verified analytically using a GC method with FID detection.

Results

There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure.

Conclusion

The test material showed no relevant toxic potential at concentrations above the limit of water solubility.

Description of key information

For this endpoint data from a long term (28 d) bioconcentration study provide adequate information. This study has used SPAN 20 as vehicle to increase water solubility. In the long term 28 days study no mortality was observed up to 0.03 mg/L. Therefore the test material does not exhibit a significant potential for toxicity up the limit of water solubility.

Key value for chemical safety assessment

Additional information