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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Aug - 14 Aug 1993
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:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl laurate
EC Number:
233-560-1
EC Name:
Isopropyl laurate
Cas Number:
10233-13-3
Molecular formula:
C15H30O2
IUPAC Name:
isopropyl laurate
Details on test material:
- Name of test material (as cited in study report): Isopropyl laurate
- Physical state: clear, pale-yellow viscous liquid
- Analytical purity: no data

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Concentrated solutions of 2 L were prepared by direct adding of test substance to dilution water
- to aid dispersion, these stocks were subjected to ultrasound treatment for 30 minutes
- these stocks were subsequently diluted to give a final volume of 16 litres

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Fish Network Ltd., Blackborough, Devon, fish reared from the eggs at Exmoor Trout Farm, hatching early March 1993 and were moved to laboratory on 2 Jun 1993;
- Age at study initiation: approx. 4-5 months
- Length at study initiation: 5.3 cm (mean fork length)
- Weight at study initiation: 1.41 g (mean)
- Feeding during test: last feeding approx. 23 hours prior to start of definitive test

ACCLIMATION
- Acclimation period: six weeks
- Acclimation conditions (same as test or not): not the same; 14.1-14.2°C, flow-through system, pH. 7.7-7.9; dissolved oxygen ranging from 94 to 100%, hardness 204 to 228 mg/L as CaCO3, feeding of 1-2% of WW daily: proprietary trout pellets
- Health during acclimation (any mortality observed): <0.5% during 14 days prior to definitive study

Study design

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

Test conditions

Hardness:
approx. 190-240 mg CaCO3/L
Test temperature:
13.9 - 15.5 °C
pH:
7.8 - 8.3
Dissolved oxygen:
89 - 100%
Nominal and measured concentrations:
nominal: 0, 62.5, 125, 250, 500 and 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 25 L all-glass aquaria, 16 L test volume
- Aeration: pasteur pipette connected to an oil-free supply of compressed air
- Renewal rate of test solution (frequency/flow rate): at 48 hours (half-time)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates):1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:blend of tap water filtered through activated carbon to remove chlorine with tap water softened by reverse osmosis

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light with periods of subdued light from and into dark conditions
- Light intensity: overhead fluorescent tubes

EFFECT PARAMETERS MEASURED: mortality and sublethal effects during the first hours of the test and after 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: factor 2 beginning at 62.5 mg/L
- Range finding study
- Test concentrations: control, 1, 10, 100 and 1000 mg/L
- Results used to determine the conditions for the definitive study: The range-finding study indicated that the LC50>1000 mg/L, loss of coordination in the beginning (with consequent adaptation) and lethargy and darkened pigmentation could be observed at the end of the testing period of 48 hours.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
62.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: pigmentation and swimming behaviour
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: At 500 and 1000 mg/L: 4 fish exhibited darkened pigmentation, the two in 1000 mg/L also swam vertically (nose pointing upwards) within 30 minutes; after two hours 2 fish started to recover (one in each concentration); at 96 hours, the two remaining fish were only slightly darkened; at 250 mg/L, 4 fish exhibited darkened pigmentation at 2 hours, 48 and 96 hours; however at 30 minutes, 24 and 72 hours, no pigmentational changes could be observed; at 125 mg/L, two fish after two hours and one fish at 96 hours showed darkened pigmentation, between these hours, they appeared normal
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: at 62.5 and 125 mg/L, the test media were clear and colourless with oily globules of material visible on their non-homogeneous, hazy dispersions with undissolved test material present on their surfaces.

Any other information on results incl. tables

Sublethal observations / clinical signs:

No mortalities observed in the 96 hour test period at any concentration.

Applicant's summary and conclusion