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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-07-04 to 1994-07-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): WITAMOL 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: none
Analytical monitoring:
yes
Details on sampling:
- Concentrations: WAF
- Sampling method: For analytical determination a sample of each daily freshly prepared stock solution was directly taken. For stability measurement one sample without fish was maintained for 24 hours and then analyzed.
- Sample storage conditions before analysis: no data
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 1 g test substance was given into 1L drinking water, stirred for 18 hours, subsequently filtered. The test solutions were freshly prepared every day.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Strain: Brachydanio rerio
- Source: West Aquarium, Bad Lauterberg, Germany
- Age at study initiation (mean and range, SD): not mentioned
- Length at study initiation (length definition, mean, range and SD): 3 ± 0.5 cm, no further details mentioned
- Weight at study initiation (mean and range, SD): approx. 0.13 g mean weight
- Method of breeding: not mentioned
- Feeding during test: none


ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): The fish were kept in 200 L earthenware basins, or in 300 L glass aquariums in flow rate.
- Type and amount of food: TetraMin, administration in an amount of approx. 1 % of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): The animals showed a normal behaviour pattern at the beginning of the test and were free from visible diseases. The mortality rate during the holding phase was <5% seven days before the beginning of the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
12.3 °dH
Test temperature:
20 - 22 °C
pH:
7.8 - 8.5
Dissolved oxygen:
92 - 105 % O2 saturation
Salinity:
not mentioned
Nominal and measured concentrations:
Nominal: WAF
Measured: 0.32 mg/L (mean of freshly prepared test solutions)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): not mentioned
- Material, size, headspace, fill volume: approx. 30 L, 10 L fill volume, no further details mentioned
- Aeration: continously, no further details mentioned
- Renewal rate of test solution (frequency/flow rate): daily renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.13 g fish/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water, Gelsenwasser AG, Germany
no further details mentioned
- Intervals of water quality measurement: not mentioned

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours darkness
- Light intensity: not mentioned


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality after 24, 48, 72 and 96 hours; pH, temperature, O2 saturation at the end of the test


TEST CONCENTRATIONS
- Spacing factor for test concentrations: not mentioned
- Range finding study: not performed
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.32 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: not determined
- Observations on body length and weight: not performed
- Other biological observations: none
- Mortality of control: 0/10
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not mentioned
- Effect concentrations exceeding solubility of substance in test medium: not applicable
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
no statisitcs performed

 concentration[mg/L]  No. of fish at start of study  observation period                     
     24 h  48 h 72 h 96 h
     No. dead  mortality [%]  No. dead  mortality[%]  No. dead  mortality[%]  No. dead  mortality[%]
control   10  0  0  0  0  0  0  0  0
0.32   10  0  0  0  0  0  0  0  0
Validity criteria fulfilled:
yes
Conclusions:
In the range of water solubility not toxic under test conditions.
Executive summary:

In the range of water solubility 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters were not toxic under test conditions.

The 96 hour LC50 was in excess of 0.32 mg/L, the highest concentration investigated which was at or in excess of the water solubility of the substance.

Description of key information

In the range of water solubility 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters were not toxic under test conditions. The 96 hour LC50 was in excess of 0.32 mg/L, the highest concentration investigated which was at or in excess of the water solubility of the substance.

Key value for chemical safety assessment

Additional information

The acute toxicity of various phthalate esters was assessed in a number of freshwater fish species over a 96 hour period. No toxicity was observed up to the highest concentration tested. The 96 hour LC50 of 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was in excess of 0.32 mg/L, the highest concentration investigated which was at or in excess of the water solubility of the substance.

For the structurally related substances 1,2-Benzenedicarboxylic acid, diundecyl esters the LC50 in rainbow trout was in excess of 1.4 mg/L, in fathead minnow was in excess of 1.3 mg/L and in bluegill was in excess of 0.73 mg/L. These values represent the highest concentrations examined which were at or in excess of the water solubility of the phthalates.

Adams et al. (1995) concluded in general that phthalate esters with alkyl chain lengths of six carbon atoms or more were not acutely toxic at concentrations up to their respective limits of water solubility. In addition, DeFoe et al. (1990) reported for di-n-octyl-ortho-phthalate, di-n-octyl-iso-phthalate and di-n-octyl-tere-phthalate that they were not acutely toxic to fathead minnow at concentrations that exceeded the water solubility estimates for each of the phthalates.

Acute toxicity to a marine species, sheepshead minnow, has also been determined with the structurally related substance Diundecyl phthalate. The 96 hour LC50 was in excess of 0.22 mg/L, the highest concentration investigated which was at or in excess of the water solubility of the substance.