Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
from 1988-07-11 to 1988-07-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No full study report, only summarised results
Principles of method if other than guideline:
No data concerning used method.
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Weight at study initiation: 0.50 g (mean weight)

No further details mentioned
Test type:
static
Water media type:
not specified
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
15 +/- 1 °C
Nominal and measured concentrations:
1 mg/L
Details on test conditions:
10 fish/concentration were used, no further details mentioned
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
mortality
concentration [mg/L]  % survivors         
   24 h  48 h  72 h  96 h
 0 (control)  100  100  100  100
 1  100  100  90  90
Validity criteria fulfilled:
not specified
Conclusions:
The LC50 of the test substance was greater than 1 mg/L under the conditions described.
Executive summary:

The LC50 of 1,2,4 -Benzenetricarboxylic acid, mixed decyl and octyl triesters was greater than 1 mg/L, tested with Salmo gaidneri.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Specific details on test material used for the study:
- Lot/batch No.: 001101TMO
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0, 100 mg/l, sampled before test started & after the end of the 24 hour exposure period
- Sampling method: 1.0 - 2.0 mL sampled from test vessels every 24 hours when test solutions changed
- Sample storage conditions before analysis: No data
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution at 3000 mg/L ( with solubilizer hydrogenated castor oil HCO-50) was added to dilution water to achieve required nominal concentration
- Eluate: dechlorinated (passed through activated charcoal) tap water
- Controls: control & dispersant control: Yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): hydrogenated castor oil HCO-50
- Concentration of vehicle in test medium (final test solution(s) including control(s)): 100 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Slight white turbidity but no precipitation
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Oryzias latipes
- Strain: Oryzias latipes
- Source: Yatomi area fish farm, Aichi, Japan
- Length at study initiation (length definition, mean, range and SD): 21.6 mm (20.5 - 23.4 mm)
- Weight at study initiation (mean and range, SD): mean (n=10) : 0.1602 g (0.1287 - 0.1889 g)
- Feeding during test: No

ACCLIMATION
- Acclimation period: 12d
- Health during acclimation (any mortality observed): Not reported, any group with no mortality in last 7 days selected as suitable for test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No
Hardness:
37 mg/ml, as CaCO3
Test temperature:
23.1-23.9 °C
pH:
6.9-7.5
Dissolved oxygen:
6.3-9.7 mg/l
Salinity:
N/A fresh water
Nominal and measured concentrations:
nominal concentrations: 0, 100 mg/L
measured concentrations at 0h:<0.006, 90.7 mg/L respectively
measured concentrations at 24h: <0.006, 94.8 mg/L respectively
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker
- Material, size, headspace, fill volume: 3L
- Aeration: None
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): 24 hours
- No. of organisms per vessel: 10 fish of one group
- 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: ca. 0.5 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water after dechlorinated by passing through activated charcoal
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: room light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality/clinical signs assessed daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A limit test
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study: Yes - Indicated LC50 > 125 mg/L
Reference substance (positive control):
yes
Remarks:
Copper (II) sulphate pentahydrate
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: N/A
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: At 24 hr, one fish exposed to dispersant control showed abnormal breathing behaviour.
- Mortality of control: 1 fish exposed to dispersant control found dead at 48 hours; 1 fish exposed to 100 mg/L found dead at 96 hours.
- Other adverse effects control: None
- Abnormal responses: None other than noted above
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test solution became cloudy at 100mg/L concentration, but no precipitation. occurred
- Effect concentrations exceeding solubility of substance in test medium: Not reported
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: 0.46 mg/L (96 hours).
- Reference substance used: Copper(II)sulphate pentahydrate.
Reported statistics and error estimates:
Not required as a limit test

 

                   Mortality (%) of Oryzias latipes exposed to

                        Nominal concentration (mg/L)     Cumulative number of dead fish (% mortality)

                                                                                   24 hour        48 hour        72 hour        96 hour

                                    Control (())                                 0(0)             0(0)            0(0)             0(0)

                          Dispersant Control  (0)                       0(0)            1(10)          1(10)            1(10)

                                      100                                           0(0)             0(0)             0(0)            1(10)

 

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions in which this study was performed the LC50 (96h) > 100mg/L for fish.
Executive summary:

Acute toxicity to fish has been investigated in a 96 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The LC50 (96h) was determined to be >100 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
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. For read-across justification see Section 13.
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: WSF, measured every day (days 0 - 3)
- Sampling method: One sample was taken directly from the stock solution and analyzed, a second sample was taken out of an aquarium which was set up with test solution but without fish after 24h and analyzed to determine the test item's stability under test conditions.
- Sample storage conditions before analysis: not mentioned
Vehicle:
no
Details on test solutions:
As the substance is poorly soluble in water, an aqueous filtrated stock solution was prepared. The content of dissolved organic carbon in the water was 3 mg/L in average.
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, no further details mentioned
- 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 °d.H. (German hardness)
Test temperature:
21 ± 1 °C
pH:
7.8 - 8.4
Dissolved oxygen:
92 - 105 % relative to saturation
Salinity:
not mentioned
Nominal and measured concentrations:
Nominal: WAF
Measured: 3.0 mg/L (geometric mean of measurement of freshly prepared and after 24 hours solutions)
Details on test conditions:
TEST SYSTEM
- Test vessel: 30 L aquarium
- Type (delete if not applicable): not mentioned
- Material, size, headspace, fill volume: 30 L total, 10 L fill volume, no further details mentioned
- Aeration: continuously, 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/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 applicable (limit test, test concentration limited by test item's water solubility)
- Range finding study: not applicable (see above)
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: no mortality at limit of water solubility
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mortality
Remarks on result:
other: no mortality at limit of water solubility
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
no statistics performed, as no mortality occurred

 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
 3  10  0  0  0  0  0  0  0  0
Validity criteria fulfilled:
yes
Conclusions:
Not toxic under test conditions in the range of water solubility.
Executive summary:
The acute toxicity of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters to Zebra fish (Brachydanio rerio) was determined in a 96 -hour static test according to the Commission Directive 92/96/EEC, Annex Part C.1, dated December 29, 1992 and the OECD Guideline for Testing of Chemicals No. 203, adopted July 17, 1992. The test was performed in compliance with Good Laboratory Practice Regulations. Due to the low water solubility limit of the test substance a filtrate of a 1 g/L in tap water (stirring for 18 hours) was tested. Analytical verification was done by means of DOC determination. The measured values of the test solutions after 24 hours deviated more than 20% from the values of the freshly prepared solutions. Therefore the geometric mean (3.0 mg/L) of the these solutions were used for evaluation. Additionally a control was tested in parallel.

No lethality of Brachydanio rerio was observed at the tested concentration after 96 hours exposure.

Description of key information

Short-term toxicity to fish: LC50 - >100 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

Acute toxicity to fish has been investigated in a 96 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The LC50 (96h) was determined to be >100 mg/L.

Tests with a structural analogue of the registered substance, a trimellitate ester with mixed C8 -C10 side chains, showed no toxicity when tested at, or above, the limits of water solubility.