Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
the result of the acute toxicity test is part of a range-finding test for chronic toxicity toward fish.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: US. EPA, 1994 Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater organisms. 3rd Ed.. EPA/600/4-91/002. U.S. Environmental Protection Agency, Environmental Monitoring Systems Laboratory, Cincinnati, Ohio.
Deviations:
no
GLP compliance:
no
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material :
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stocks of the test substance were prepared each day in moderately hard synthetic freshwater, and these stocks were used to dose the test solutions.
- Eluate: Synthetic moderately hard water (US EPA 1993) served as laboratory dilution water for the tests. Batches of this water were made by passing deionized water through activated carbon, adding reagent grade chemicals, and aerating overnight. The water was stored at 20°C under gentle aeration until needed up to 14 days. Conductivity: 248 - 319 µS/cm
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Not specified
Test organisms (species):
Pimephales promelas
Details on test organisms:
Pimephales promelas (fathead minnow) were obtained from EA's Culture Facility. Brood organisms were maintained in recirculating dechlorinated tap water at 20°C in 10-gallon aquaria. Eggs produced from the brood system were removed from the brood aquaria and placed into dechlorinated tap water at 25°C for the incubation period. Newly hatched larvae, less than 24 hours old, from lots FH 2-9/16-17 were used in the rangefinding toxicity testing.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d
Remarks on exposure duration:
The total exposure in the test is 7d (range finding test for another chronic test with Pimephales promelas) but acute toxicity results were calculated for 96h exposure.
Post exposure observation period:
none
Hardness:
Not measured
Test temperature:
24.0-25.7 (°C)
pH:
7.8 - 8.3
Dissolved oxygen:
4.0 - 8.5 mg/L
Salinity:
not applicable
Nominal and measured concentrations:
100, 50, 25, 12.5 and 6.25 mg/L test substance and a dilution water control.
Details on test conditions:
Larval fish <24 hours old were randomly loaded into the test chambers. 2 replicates of 10 organisms were used per concentration and control. The test chambers were 1-liter plastic beakers with 250 ml of test solution. During testing, organisms in each test chamber were fed daily a suspension of brine shrimp Artemia nauplii. The uneaten and dead brine shrimp were removed from the test vessels daily. The test solutions were renewed each day by siphoning 80 percent of the old test solutions from the test vessels and replacing with freshly made test solutions.
Reference substance (positive control):
yes
Remarks:
cadmium chloride
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% confidence limits: 14.2 - 29.7 mg/L
Details on results:
At test termination, there were no surviving organisms in the 50 and 100 mg/L test substance concentrations and 55 percent survival in the 25 and 12.5 mg/L test substance concentrations. The 6.25 mg/L test substance concentration was excluded from analysis due to anormalous mortality. The control had 95 percent survival and mean growth of 0.649 mg/organism. Mean growth in the 12.5 and 25 mg/L test concentrations was 0.650 mg/organism and 0.417 mg/L organism, respectively. There was a statistically significant difference (p=0.05) between the 25 mg/L test substance concentration and the control. The 96-hour LC50 was 22.0 mg/L test substance (nominal concentration)
Results with reference substance (positive control):
Results of the test with cadmium chloride: IC25= 22.1 mg/l CdCl2 ; acceptable control chart limits of 11.2 - 35.2 mg/l.
Reported statistics and error estimates:
The results of the toxicity tests were analyzed using the ToxCalc statistical software package (Version 5.0, Tidepool Scientific Software) and followed US EPA guidance (US EPA 1994).
Sublethal observations / clinical signs:

Results of the test for 3,4'-oxydianiline

 Nominal test concentration (mg/L) 96h - % survival  7 d survival Mean growth (mg/organism +/- SD) 
 Control  95  95  0.649 (+/-0.018)
 6.25  -  -  -
 12.5  60  55  0.650 (+/- 0.057)
 25  60 55  0.417 (+/- 0.066) 
 50  10  -
 100  0  -

Endpoints (as mg/L oxydianiline)

96-Hour LC50: 22.0 (14.2-29.7) (d)

Validity criteria fulfilled:
yes
Remarks:
The result with the reference substance (cadmium chloride) is within the range of the validity criteria.
Conclusions:
A preliminary test for a chronic toxicity test with early stages of Pimephales promelas was conducted on fish larvae for 7 days with 3,4'-oxydianiline. The results of survival at 96h were used as results of acute toxicity test with fish: LC50-96h = 22.0 mg/L (nominal concentration).
Executive summary:

A preliminary test for a chronic toxicity test with early stages of Pimephales promelas was conducted on fish larvae for 7 days with 3,4'-oxydianiline. This test can be used to assess acute toxicity to fish. The results of survival at 96h were used as results of acute toxicity test with fish: LC50-96h = 22.0 mg/L (nominal concentration). As such, the analogue substance is deemed to affect the survival of the juveniles under the conditions of the test.

Description of key information

A preliminary test for a chronic toxicity test with early stages of Pimephales promelas was conducted on fish larvae for 7 days with the analogue 3,4'-oxydianiline. This test can be used to assess acute toxicity to fish. The results of survival at 96h were used as results of acute toxicity test with fish: LC50-96h = 22.0 mg/L (nominal concentration). As such, the analogue substance is deemed to affect the survival of the juveniles under the conditions of the test.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
22 mg/L

Additional information