Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
068424-26-0
Cas Number:
068424-26-0
IUPAC Name:
068424-26-0
Constituent 2
Reference substance name:
Fatty acids, C16-18 and C18-unsatd.
EC Number:
266-932-7
EC Name:
Fatty acids, C16-18 and C18-unsatd.
IUPAC Name:
Fatty acids, C16-18 and C18-unsatd.
Details on test material:
no data
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
- Water solubility: soluble

Sampling and analysis

Analytical monitoring:
not specified
Details on sampling:
no data

Test solutions

Vehicle:
no
Details on test solutions:
First a stock solution of 10 g/l of the test substance was prepared. From this solution appropriate aliquots were pipetted into the test vessels and filled up to final volumes of 5 l with standard dilution water (pH 7.8 ± 0.2, about 250 mg CaCO3/ll, oxygen saturated)

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Mortality (prior to test): < 0.1%
Pretreatment: none
Feeding: not during the test
Number of test organisms: 10 fish per concentration

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none

Test conditions

Hardness:
about 250 mg CaCO3/l
Test temperature:
22.5 - 23.5°C
pH:
8.0 - 8.1
Dissolved oxygen:
8.6 - 9.8 mg O2/l
Salinity:
no data
Nominal and measured concentrations:
Concentration of the test substance: 16, 32, 45, 64 and 90 mg/l
Details on test conditions:
Test vessels: 10 l fish basins containing 5 l test water
Light: about 16 hours illumination per day
- Concentration of the test substance: 16, 32, 45, 64 and 90 mg/l
-Mortalities are recorded at 0, 6, 24, 48, 72 and 96 hours
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
27 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
46 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
77 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Details on results:
the fish did not show any abnormal behaviour.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortality [%]

Conc.

Incubation time [h]

[mg product/l]

0

6

24

48

72

96

16

0

0

0

0

n.d.

0

32

0

0

0

0

n.d.

0

45

0

0

0

40

n.d.

60

64

0

0

0

60

n.d.

80

90

0

0

0

100

n.d.

100

 n.d. = not determined

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Fatty acids, C16-18 and C18-unsatd., sodium salts turned out to be moderately toxic to Zebra-fish.
Executive summary:

The acute toxicity of Fatty acids, C16-18 and C18-unsatd., sodium salts to Zebra-fish was determined according to the OECD-guideline 203.

The product was tested in a concentration range of 16 to 90 mg product/l (nominal).

The incubation period was 96 hours under semistatic conditions ( the test-solution were renewed daily).

Following results were obtained:

LC0: 32 mg product/l = 27 mg active matter/l

LC50: 54 mg product/l = 46 mg active matter/l

LC100: 90 mg product/l = 77 mg active matter/l

Fatty acids, C16-18 and C18-unsatd., sodium salts turned out to be moderately toxic to Zebra-fish.