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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
96 hours
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
EC Guideline L383A-C.1
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
1-isopropyl-2,2-dimethyltrimethylene diisobutyrate
EC Number:
EC Name:
1-isopropyl-2,2-dimethyltrimethylene diisobutyrate
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): TXIB Plasticizer
- Physical state: liquid
- Analytical purity: 99.0%
- Lot/batch No.: EOC 22998 #10
- Expiration date of the lot/batch: 10/99

Sampling and analysis

Analytical monitoring:
Details on sampling:
- Concentrations: 0.65, 1.1, 1.8, 3.0, 5.0 mg active ingredient/L
- Sampling method: Duplicate measures of each test concentration at 0 and 96 hours

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.0375 mL/minute of 50 mg a.i./mL stock solution introduced into mixing system with 0.0375 L/minute dilution water to achieve
highest nominal test concentration of 5.0 mg a.i./L. Highest concentration proportionally diluted (60% ) to produce remaining exposure
concentrations (3.0, 1.8, 1.1, 0.65 mg a.i./L)
- Controls: dilution water and solvent controls
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): Stock solution prepared by diluting 7.583 g
(7.500 g as active ingredient) of test substance with acetone vehicle to a volume of 150 mL to achieve 50 mg a.i./L solution. 0.4 mL/mL solvent
control stock solution prepared by diluting 120 mL of acetone with distilled water to a volume of 300 mL. Acetone concentration in solvent control
and highest test concentration was 0.10 mL/L. Remaining exposure concentrations proportionally diluted (60%).
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No visible sign of undissolved test substance in stock solution or highest
exposure concentration

Test organisms

Test organisms (species):
Lepomis macrochirus
Details on test organisms:
- Common name: Bluegill sunfish
- Source: Bybrook Hatchery, Ashford, Connecticut
- Length at study initiation (length definition, mean, range and SD): Representative sample (n=30) mean length 42 mm, range 35-50 mm
- Weight at study initiation (mean and range, SD): Representative sample (n=30) mean weight 1.1 g, range 0.51-1.8 g
- Feeding during test: No food 24 hours prior to, or during test

- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial pelleted food, ad libitum
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no mortality observed during 48 hour period prior to test

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h

Test conditions

Measured at test initiation. Units mg/L CaCO3
Control = 32
Solvent Control = 36
0.65 = 36
1.1 = 38
1.8 = 38
3.0 = 40
5.0 = 40
Test temperature:
Temperature was measure at 0, 24, 48, 72, and 96 hours in all test concentrations using a Brooklyn alcohol thermometer. The temperature was
reported to be 22C at all measurements. A continuous temperature monitor of the solvent control solution indicated a range of 21 to 23C during
the exposure period.
pH was measured at 0, 24, 48, 72, and 96 hours in all test concentrations. Values below are ranges.
Control = 7.5-7.7
Solvent Control = 7.5-7.7
0.65 = 7.4-7.6
1.1 = 7.4-7.6
1.8 = 7.4-7.6
3.0 = 7.4-7.5
5.0 = 7.4-7.5
Dissolved oxygen:
Dissolved oxygen was measured at 0, 24, 48, 72, and 96 hours in all test concentrations. Values below are ranges in mg/L (% saturation).
Control = 8.0-8.5 (92-97)
Solvent Control = 8.0-8.3 (92-95)
0.65 = 7.7-8.2 (88-94)
1.1 = 7.0-8.1 (80-93)
1.8 = 7.3-7.9 (84-91)
3.0 = 7.5-8.1 (86-93)
5.0 = 7.1-8.1 (81-93)
Nominal and measured concentrations:
See Table 1 below.
Details on test conditions:
- Test vessel: Aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 49.5 x 25.5 x 29 cm, 14 cm standpipe, 18 L volume
- Aeration: no aeration
- Type of flow-through (e.g. peristaltic or proportional diluter): proportional diluter
- Renewal rate of test solution (frequency/flow rate): 6 volume replacements/day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: maximum of 0.10 g biomass/L of flowing test solution/day

- Source/preparation of dilution water: Well water
- Total organic carbon: 1.0 mg/L
- Metals: Analyzed periodically. Not detected in toxic concentrations per ASTM (1996) standard practice.
- Pesticides: Analyzed periodically. Not detected in toxic concentrations per ASTM (1996) standard practice.
- Alkalinity: 32-35 mg/L
- Conductivity: 125-135 umhos/cm specific conductance
- Intervals of water quality measurement: DO, temperature and pH measured once daily in each treatment level and controls

- Adjustment of pH: no adjustment
- Photoperiod: 16 hours light and 8 hours darkness/day with transistions from light to dark and vice versa
- Light intensity: Measured but value not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Biological observations (lethality) as well as sublethal effects (erratic
swimming behavior, lethargy) made and recorded at 0, 3, 6, 24, 48, 72 and 96 hours of exposure.

- Spacing factor for test concentrations: 60%
- Range finding study
- Test concentrations: 5, 10 and 20 mg/L nominal concentrations used to evaulate solubility of test substance. Organisms in 5 mg/L solution only
- Results used to determine the conditions for the definitive study: 10 and 20 mg/L solutions exhibited undissolved test substance (surface film). 5.0 mg/L nominal determined to be highest concentration achievable without exceeding solubility.

Reference substance (positive control):
not required

Results and discussion

Effect concentrations
96 h
Dose descriptor:
Effect conc.:
>= 6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
as active ingredient
Basis for effect:
mortality (fish)
with no sublethal effects observed
Details on results:
- Behavioural abnormalities: none observed
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not observed
- Effect concentrations exceeding solubility of substance in test medium: none
Reported statistics and error estimates:
No adverse effects observed in any of the treatments or controls. Endpoint determined empirically.

Applicant's summary and conclusion

Validity criteria fulfilled:
Well conducted GLP study demonstrating no observable adverse lethal or sub-lethal effects at 96 hours in all concentration levels utilizing a flow
through proportional diluter system. Highest concentration tested approximated the water solubility limit of the test substance (i.e., no effect at