Fatty acids, rape-oil, Me esters

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

28 Oct - 01 Nov 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18, Me esters

EC Number:

273-095-1

EC Name:

Fatty acids, C12-18, Me esters

Cas Number:

68937-84-8

IUPAC Name:

68937-84-8

Details on test material:

- Name of test material (as cited in study report): C12-18 fatty acid methyl ester
- Analytical purity: 100% AS
- Expiration date of the lot/batch: until 12 Oct 1992

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct weighing of test substance into test solution, careful stirring

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Company "Westaquarium"

ACCLIMATION
- Acclimation period: 8 weeks
- Acclimation conditions (same as test or not): same as test, except for feeding
- Type and amount of food: Altromin 14513, specification 1410, identical with 1413, but pelleted instead of milled
- Health during acclimation (any mortality observed): <0.1% mortality in the week prior to testing

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

not relevant

Test conditions

Test temperature:

22 - 23 °C

pH:

Test begin: 8.2-8.3
Test end: 7.8-8.0

Dissolved oxygen:

Test begin: 93-97%
Test end: 65-77% (lowest oxygen saturation with the highest TS concentration)

Nominal and measured concentrations:

Nominal: Control, 100, 300 and 1000 mg/L
Measured (as DOC): for 100 mg/L 1.2 to 6.1 mg/L were measured at 0 and 24 hours and with new solution at 24 and 48 hours; for 300 mg/L, 1.7 to 6.3 mg/L were measured at 0 and 24 hours and with a new solution at 24 and 48 hours; in all cases a random distribution from within the range.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

300 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

550 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Effect concentrations exceeding solubility of substance in test medium: Only the soluble fraction of the TS could be found with the analytical testing, however, the remainder of the TS remained in disperse or seperated form in the test solution (no volatility of substance and according to the oxygen values also no biodegradation). The testing laboratory stated no problems with the test substance. however, considering the low water solubility of the substance, the observed effects are expected to be caused rather by physical interference with undissolved particles than due to toxicity

Reported statistics and error estimates:

Determination of LC50 according to Stephan (Square root of LC0 times LC100)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortality in %:

Concentration	Incubation time (h)
in mg/L	0	6	24	48	72	96
0	0	0	0	0	0	0
100	0	0	0	0	0	0
300	0	0	0	0	0	0
1000	0	0	0	30	90	100

Applicant's summary and conclusion

Executive summary:

No effects up to the limit of water solubility (WS < 1 mg/L)