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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02/12/2009 - 18/01/2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: OSPAR Comission 2005 Part B. Protocol for a fish acute toxicity test
Version / remarks:
Similar to the OECD 203 guideline adapted for OSPAR
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: Classified as soluble in seawater

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: Test substance was dissolved in seawater at 427.14 mg/ L .
- Final preparation of a solid: Dissolved in solution

FORM AS APPLIED IN THE TEST- Aqueous, In solution

Analytical monitoring:
no
Details on sampling:
- Concentrations: 427.14 mg/L test substance tested
- Sampling method: Limit test for mortality
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test material dissolved directly in seawater
- Controls: Yes, 1 mortality control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No, test item is classified as soluble in seawater.
Test organisms (species):
other: Scophthalmus maximus
Details on test organisms:
TEST ORGANISM
- Common name: Scophthalmus maximus
- Source: Ardtoe Marine Laboratory.
- Age at study initiation (mean and range, SD): Seller acclimation period 3 weeks and 5 days, testing laboratory acclimation period for 12 days.
- Length at study initiation (length definition, mean, range and SD): Measured, 3 cm average
- Weight at study initiation (mean and range, SD): Measured, 0.685 g average

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): Different conditions, smaller tank of 14 or 30 L made of soda-lime glass.
- Type and amount of food during acclimation: Food in pellet form
- Feeding frequency during acclimation: Twice a day
- Health during acclimation (any mortality observed): No mortality observed.

Test type:
semi-static
Water media type:
saltwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
Limit tests measurements taken for 24, 48, 72 and 96 hours
Test temperature:
12.8 - 13.8
pH:
Control pH 7.99 - 8.14
Definitive pH (96 hours) 8.05 - 8.12
Dissolved oxygen:
89 - 97%
Salinity:
35 - 37 ‰
Nominal and measured concentrations:
Nominal (427.14 mg/ L)
Details on test conditions:
TEST SYSTEM
- Test vessel: tanks
- Material, size, headspace, fill volume: 14 or 30 L, moulded soda-lime glass

- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter): Not specified, flow-through conditions present though
- Renewal rate of test solution (frequency/flow rate): 48 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): N/A
- Biomass loading rate: 0.685 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater from Scapa Flow, Orkney.
- Particulate matter: Sand filtered to remove particulates
- Culture medium different from test medium: No
- Intervals of water quality measurement: Prior to and following renewal of media (i.e. 48 hours)

OTHER TEST CONDITIONS
- Photoperiod: Constant illumination


EFFECT PARAMETERS MEASURED : Mortality/ immobility

TEST CONCENTRATIONS
- Test concentrations: 427.14 mg/ L
- Results used to determine the conditions for the definitive study: 427.14 mg/ L
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 427.14 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 427.14 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 427.14 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 427.14 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Observations on body length and weight: measured (length = 2.70 - 3.22 cm, weight = 0.736 - 1.272 g)
- Other biological observations: Fish were healthy in appearance and active
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: yes
Validity criteria fulfilled:
no
Remarks:
Temperature fell below the guideline criteria at various timepoints however it was considered acceptable as fish were healthy in appearance and active throughout the 96h test. This deviation was not thought to have affected the result of the test.
Conclusions:
The study concluded that the the 96 hour LC50/EC50 value was above 427.14 mg/L for the test substance.
Executive summary:

The study assesses the aquatic toxicity of 2 -Butyl butanoic acid compound with 2-aminoethanol to marine fish. The study is performed in compliance with GLP and the testing guidelines followed were OECD 203 (1992) - OECD guidelines for testing of chemicals fish, acute toxicity test and OSPAR Commission (1995) (amended March 2005) Part B, Protocol for a fish acute toxicity test. All validity criteria were complied with, with the exception test temperature which fell below the guideline criteria at various timepoints. However, the laboratory considered this acceptable in terms of test validity as fish were healthy in appearance and active throughout the 96 hour test. The test organism used was Scophthalmus maximus. The results of the definitive limit test showed that the 96 hour LC50/EC50 value was above 427.14 mg/L for the test substance (1 replicate). A mortality control was included which showed 0% mortality rates from a population of 7 organisms (1 replicate).

Description of key information

The study assesses the aquatic toxicity of 2 -Butyl butanoic acid compound with 2-aminoethanol to marine fish. The study is performed in compliance with GLP and the testing guidelines followed were OECD 203 (1992) - OECD guidelines for testing of chemicals fish, acute toxicity test and OSPAR Commission (1995) (amended March 2005) Part B, Protocol for a fish acute toxicity test. All validity criteria were complied with, with the exception test temperature which fell below the guideline criteria at various time points. However, the laboratory considered this acceptable in terms of test validity as fish were healthy in appearance and active throughout the 96 hour test. The test organism used was Scophthalmus maximus. The results of the definitive limit test showed that the 96 hour LC50/EC50 value was above 427.14 mg/L for the test substance (1 replicate). A mortality control was included which showed 0% mortality rates from a population of 7 organisms (1 replicate).

Key value for chemical safety assessment

Marine water fish

Marine water fish
Effect concentration:
427.14 mg/L

Additional information