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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study performed according to OECD Guideline 203 [1992] and EEC directive 92/69 Part C.1 [1992]. No analytical control of test concentrations.
Justification for type of information:
Please refer to the REad-across justification document enclosed in chapter 13 for more details.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test material dissolved by stirring in acetone to create stock solutions. 0.2 ml of solvent was added to 2 l of test medium and mixed
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 0.01%
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All final test solutions appeared clear and without precipitation.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp (Cyprinus carpio. Teleostei, Cyprinidae) (Linnaeus, 1758)
- Reason for selection : This system has been selected as an internationally accepted species.
- Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, NL
- Total fish used : 79
- Length at study initiation (length definition, mean, range and SD): 1.96 +/- 0.10 cm
- Weight at study initiation (mean and range, SD): 0.21 +/- 0.03 g
- Method of breeding: F1 from a single partent-pair bred in UV-treated water
- Feeding during test : no feeding from 24 hours prior to test and during total test period

ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same, with feeding; test without feeding
- Type and amount of food: Trouvit, ad libitum
- Feeding frequency: daily
- Health during acclimation (any mortality observed): < 5% mortality during the 7 days prior the start of the test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
250 mg CaCO3/L
Test temperature:
20.5 deg C
pH:
7.6 - 8.1
Dissolved oxygen:
9.2 - 8.7 mg/L
Salinity:
Iso medium (Ca++, Mg++, Na+, K+, Cl-, SO4 2-, HCO3-); total 351 mg / L
Nominal and measured concentrations:
Nominal: 10, 5.6, 3.2, 1.8, 1.0 mg/L test material plus a solvent and a negative control
Analytics have not been performed
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 liters
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass
- Aeration: continously
- No. of organisms per vessel: 7 fish per concentration and control
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.74 g fish / litre, e.g. 7 fish per 2 litres of test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Millipore reverse osmosis tap water, supplemented with salts to generate iso medium
- Particulate matter: none observed
- Intervals of water quality measurement: Oxygen, pH, temperature: daily // Ammonia, Nitrite, Nitrate once a week.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours / day

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- mortality (at 2, 24, 48, 72 and 96 hours after start of treatment)
- disturbance of swimming behaviour (at 2, 24, 48, 72 and 96 hours after start of treatment)

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study
- Test concentrations: 0.1, 1, 10, 100 mg/L in Rang-Finding study
- Results used to determine the conditions for the definitive study: 100% mortality at 100 and 10 mg/L, 0% mortality at 1 mg/L in RF study
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
>= 5.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
<= 3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: Swimming behaviour disturbed at 48 hours of 3 moribund fish at the concentration of 5.6 mg/l
- Observations on body length and weight: no data
- Other biological observations: no data
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no observations
- Effect concentrations exceeding solubility of substance in test medium: no data
Validity criteria fulfilled:
yes
Conclusions:
The LC50 in carp after 96 hours of treatment is 4.2 mg/L with 0% mortality at 3.2 mg/L and 100% mortality at 5.6 mg/L.
Executive summary:

In the acute toxicity study in carp, each 7 fish were exposed for 96 hours to diluted solutions of TK 12576. Acetone was used as a solvent at 0.01% in the test medium. The concentration range tested was selected on the basis of results obtained in a range finder study. The LC50 after 96 hours of treatment was 4.2 mg/L with 0% mortality at 3.2 mg/L and 100% mortality at 5.6 mg/L.

Description of key information

Short term toxicity from three trophic levels (Daphnia, Fish and Algae) is available for the m-isomer and for two trophic levels (Fish and Algae) for the p-isomer substance. The most conservative end point will be taken for the short term toxicity to fish.

In a 96-hour acute toxicity study in carp by M. Bogers(1996) conducted on p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline. In the non-GLP study performed according to OECD Guideline 203 [1992] and EEC directive 92/69 Part C.1 [1992], an LC50 after 96 hours of treatment was derived as 4.2 mg/L with 0% mortality at 3.2 mg/L and 100% mortality at 5.6 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
4.2 mg/L

Additional information