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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and Guideline-Study with no or minor deficiencies.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
other: Guideline 79/831/EWG Appendix V Methods for determination of ecotoxicity C.1. Acute toxicity on fish
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 2-amino-5-fluorobenzoate
EC Number:
608-681-1
Cas Number:
319-24-4
Molecular formula:
C8 H8 F N O2
IUPAC Name:
methyl 2-amino-5-fluorobenzoate
Test material form:
other: light yellow mass

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Representative sample of total water amount 10 l: 20 ml
Appearance: solution
Temperature: 22 +/- 1°C

Test solutions

Vehicle:
yes
Details on test solutions:
The test substance was weighed into a beaker and made to a paste using 0.095 ml Tween 80/l. Water for dilution was added and the mixture homogenised using an Ultra-Turrax and Ultrasonic bath.
In order to determine the test substance concentration, water samples were taken from the middle of the test chamber by pipetting at study start and after 48 and 96 h. The analytical values were in a range of +/- 20% of the nominal concentrations.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
The fish were kept at least 14 days before the start of the study in water for dilution..
TEST ORGANISM
Common name: Brachydanio rerio
Strain: Hamilton-Buchanan
Breeding station: Corporate Toxicology Hoechst AG
Age at study initiation (mean and range, SD): 60 d
Length at study initiation (length definition, mean, range and SD): 2.9-3.4 cm, mean 3.2 cm, s=0.2
Feeding during test: No

ACCLIMATION:
Acclimation period: 14 d
Acclimation conditions (same as test or not):
Temperature: 22°C
Oxygen content: >= 80 % of saturation value
Light period: 12 h/d
Population density: <= 1 g Fish/l water
Type and amount of food: Tetra Min, Tetra Werke Melle (FRG)
Feeding frequency: twice a day ad libitum

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
2.5 mmol/l Ca2+ and Mg2+
Test temperature:
22±1 °C
pH:
8.0-8.3
Dissolved oxygen:
Oxygen content > 80 % of the saturation value
Nominal and measured concentrations:
0 (Ctrl), 0 (Ctrl with Tween 80), 10, 22, 50 mg/l nominal
The measured concentration all have been in the range of 80-120% of nominal values
Reference substance (positive control):
yes
Remarks:
water and water/tween 80

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Results with reference substance (positive control):
no lethals
Reported statistics and error estimates:
Probit analysis could not be carried out because of the lethality rate. As the factor for the concentration steps was 2.2 (third root of 10), no further concentrations were tested.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test item after 96 h is 22-50 mg/l.