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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2003-01-21 to 2003-01-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted to an appropiate guideline under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Oryzias latipes
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 18.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Maximum concentration tested at limit of solubility under test conditions.
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
18.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: Mortality and behavioural abnormalities

Table 1:      Measured concentrations of terephthalic acid during a 96 -hour, semi-static acute toxicity test with himedaka (Oryzias latipes).

Nominal TPA concentration (mg/L)

Measured TPA concentration (mg/L)

Mean measured as % of nominal

0 hours
(fresh)

24 hours
(expired)

mean

0 (control)

< 0.5

< 0.5

-

-

0 (solvent control)

< 0.5

< 0.5

-

-

18

18.4

18.7

18.6

103

 

Table 2:      Mortality and sublethal effects among himedaka (O. latipes) exposed to terephthalic acid for 96 hours under semi-static conditions.

Mean measured TPA concentration (mg/L)

Mortality (%) and sublethal effects
(Number of fish showing abnormalities/number of survivors)

24 hours

48 hours

72 hours

96 hours

control

0
(0/10)

0
(0/10)

0
(0/10)

0
(0/10)

solvent control

0
(0/10)

0
(0/10)

0
(0/10)

0
(0/10)

18.6

0
(0/10)

0
(0/10)

0
(0/10)

0
(0/10)

 

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour LC50 for himedaka (Oryzias latipes) exposed to terephthalic acid under semi-static conditions was >18.6 mg/L, based on the mean measured concentration at the limit treatment applied. The 96-hour NOEC was 18.6 mg TPA/L (mean measured), based on the absence of mortalities and sub-lethal effects at the limit treatment applied.
Executive summary:

Himedaka (O. latipes) were exposed in a semi-static test system over a period of 96 hours to terephthalic acid (TPA). The nominal limit concentration to which the test organisms were exposed was 18 mg TPA/L, intended to correspond to the solubility limit of TPA in water. T

here were single test vessels per treatment, each containing 10 fish. Media were renewed at 24 -hour intervals. Exposure concentrations were verified analytically (by HPLC/UV detection) in fresh and expired (24 -hour aged) media taken from all treatments during the first renewal period. The analytically determined concentration of the test material was 102% and 104% of nominal in fresh and 24 -hour aged medium, respectively. The mean measured limit exposure concentration was 18.6 mg TPA/L.

The LC50 (96 h) was >18.6 mg terephthalic acid/L, based on the mean measured exposure concentration at the limit treatment. Based on the absence of treatment-related mortalities or sub-lethal effects, the NOEC was 18.6 mg TPA/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991-04-15 to 1991-10-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted to an appropiate guideline under GLP.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):Not relevant
Analytical monitoring:
yes
Details on sampling:
Samples for analysis taken from three treatments (top, mid-range and bottom TPA concentrations) at 0 h and 96 h.
Vehicle:
no
Details on test solutions:
For the range finding test, the test material was directly weighed into the test vessel. No stock solution was made. The test material was dispersed in reconstituted water, but not all the test material dissolved. Based on the experience in the range finding test, a stock solution was prepared for the definitive test by treating TPA with NaOH solution to convert it to its more soluble sodium salt(s) prior to exposure. The concentration of the stock solution was 1000 mg TPA-equiv/L. The maximum voulme of NaOH solution transferred to the test vessel containing the highest TPA concentration was 16.60 mL. The "salinity" control was prepared by adding an identical volume (16.6 mL) of NaOH solution to the appropriate test vessel and then adjusting pH by addition of HCl.
Test organisms (species):
Leuciscus idus melanotus
Details on test organisms:
Leuciscus idus melanotus (golden orfe).The fish used in the definitive test were supplied by Eurofisch, D-2354 Hohenweststadt. Purchased on 30 July, 1991. During the 21-day pre-test holding period the fish were fed 50% Tetra Special Mix; 50% IBL Novo food tablets at a rate of 2% of mean fish weight, 5 times per week. The average body weight of the fish was 1.028 ±0.29 (S.D.) g/fish.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not relevant
Hardness:
193.86 mg CaCO3/L in definitive test.
Test temperature:
21.8 to 22.4 ⁰C
pH:
7.0 to 7.8
Dissolved oxygen:
90 to 98% ASV
Salinity:
Not relevant (freshwater test)
Nominal and measured concentrations:
See Table 2. The nominal concentrations to which the test organisms were exposed were 0 (control and NaOH-amended "salinity" control) 80, 130, 220, 350, 600 and 1000 mg TPA/L.
Details on test conditions:
During the definitive test the following conditions were used;- Test vessel: - glass, 16 L capacity; 20 cm tall x 31.5 cm x 29 cm - depth of water: approx 12.5 cm-Test vessels were aerated to maintain acceptable dissolved oxygen levels.-Amount of test solution per test vessel; 10 L.- no renewal of test solution- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 1, with untreated control and "salinity" control consisting of dilution water amended with NaOH solution.-Loading 1.028 g/L-Photoperiod: dark/light 8/16 h-light intensity; approximately 200 Lux-Temperature 22 ±1 ⁰C-feeding: none
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 961 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
961 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
other: mortality and behavioural abnormalities
Details on results:
Results of the definitive test are shown in Table 1 (mortality and sub-lethal effects) and Table 2 (analytical data). Exposure concentrations were verified analytically at the start and end of the test in three of the treatments. The analytically determined initial concentrations of the test material were between 93% and 115% of nominals. Residual concentrations at test-end were between 54% and 95% of nominals in all three treatments that were analysed, and 95% to 92% of nominal at the maximum concentration which defined the endpoint of the study. In the absence of mortalities, the LC50 could not be determined, but it exceeded the highest concentration applied. In the report, the endpoint is given as >922 mg/L, apparently the mean measured value at the highest concentration, but based on the 96-h data only, i.e. (938.4 + 906.0)/2. This is incorrect; the mean should include the 0-h data as well, i.e. (916.6 + 1082 + 938.4 + 906)/4 = 961 mg/L.
Results with reference substance (positive control):
No reference substance used.
Reported statistics and error estimates:
Not relevant (no effect at highest concentration).

Table 1: Effects on L. idus melanotus following 96-hour exposure to terephthalic acid (sodium salt(s)), under static conditions. Percentage mortality and occurrence of symptoms of toxicity (no. displaying sub-lethal effects/number of surviving fish per treatment).

Time (h)

Nominal terephthalic acid concentration (mg/L)

0 (Control)

0 (Salinity control)*

80

130

220

350

600

1000

0

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

3

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

6

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

24

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

48

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

72

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

96

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

0 (0/10)

* The “salinity control consited of dilution water amended with NaOH solution only.

Table 2: Measured concentrations of terephthalic acid during a 96 hour, static acute toxicity test with L. idus melanotus

Exposure Period (h)

Nominal Terephthalic Acid conc. (mg/L)

Measured Terephthalic Acid conc. (mg/L)

Measured as percentage of nominal %

0

130

126.2

139.5

98

108

0

350

365.8

399.8

106

115

0

1000

916.6

1082

93

109

96

130

90.4

92.4

70

72

96

350

212.8

185.9

61

54

96

1000

938.4

906.0

95

92

In the report, the endpoint is given as >922 mg/L, apparently the mean measured value at the highest concentration, but based on the 96-h data only, i.e. (938.4 + 906.0)/2. This is incorrect; the mean should include the 0-h data as well, i.e. (916.6 + 1082 + 938.4 + 906)/4 = 961 mg/L.

Validity criteria fulfilled:
yes
Conclusions:
The static 96-h LC50 of terephthalic acid (converted to its sodium salt prior to exposure) to L. idus melanotus was >961 mg/L, based on the mean measured concentration at the maximum treatment applied.
Executive summary:

Golden orfe (L. idus melanotus) were exposed in a static test system over a period of 96 hours to terephthalic acid (TPA) after conversion to its sodium salt. The nominal concentrations to which the test organisms were exposed were 80, 130, 220, 350, 600 and 1000 mg TPA/L. There were single test vessels per treatment, each containing 10 fish. Exposure concentrations were verified analytically at the start and end of the test in three of the treatments. The analytically determined initial concentrations of the test material were between 93% and 115% of nominals. Residual concentrations at test-end were between 54% and 95% of nominals in all three treatments that were analysed, and 95% to 92% of nominal at the maximum concentration which defined the endpoint of the study.

The LC50 96 h) was >961 mg/L terephthalic acid (tested as sodium terephthalate), based on the mean measured exposure concentration at the highest treatment. Based on the absence of treatment-related mortalities or sub-lethal effects, the NOEC was 961 mg TPA/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
96-hour acute exposure, dates not given
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Only results table given. No procedural details provded.
Qualifier:
no guideline followed
Guideline:
other: (no references given)
Principles of method if other than guideline:
No information provided.
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Pimephales promelas
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Animal No and species

Conditions**

Date

Dose Range

mg or µl/l

Test start

Test end

LT50 (hours)

Survivors at end of test (hours)

Temp

DO

pH

Temp

DO

pH

10 Pp

S, SL. F

2-21-77

100 mg/la, b

17

8.4

8.3

20

2.0

7.4

>96

10 (96)

Species:                                           LC50:

Pp = pimephales promelas                    >100 mg/L

**S = static, F = fluorescent (lighting), SL = solid,

Remarks:a8 mL of 20% NaOH used to solubilise compound

              bNo higher levels tested because of solubility problems

Validity criteria fulfilled:
not specified
Conclusions:
The 96-h LC50 for the fathead minnow (Pimephales promelas) exposed to sodium terephthalate under static conditions was >100 mg TPA-equiv/L.
Executive summary:

The 96-h LC50 for the fathead minnow (Pimephales promelas) exposed to sodium terephthalate under static conditions was >100 mg TPA-equiv/L.

Description of key information

Two reliable (Klimisch 1, guideline- and GLP-compliant) studies address the short-term toxicity of terephthalic acid to freshwater fish.   
In the first study (Government of Japan, Ministry of the Environment, 2003a), himedaka (Oryzias latipes) were exposed to high purity TPA (free acid), dosed from a stock solution prepared with DMSO, at a concentration intended to approximate to TPA's aqueous solubility limit. No toxicity was observed under these test conditions:
Himedaka (O. latipes) 96 -h LC50 (semi-static): >18.6 mg TPA/L, 96 -h NOEC: 18.6 mg TPA/L.
These endpoints are mean measured values and represent the maximum limit concentration achievable under the test conditions.
In the second study (Knacker et al., 1993a) TPA was first treated with NaOH solution, to convert the acid to its much more soluble sodium salt(s), and exposure in this study was consequently to sodium terephthalate (following neutralisation of excess alkali). No toxicity was observed under these conditions:
Golden orfe (L. idus melanotus) 96 -h LC50 (static): >961 mg TPA-equiv/L, 96 -h NOEC: 961 mg TPA-equiv/L.
These endpoints are mean measured values and represent the highest concentration applied.
Terephthalic acid and its more environmentally relevant terephthalate sodium salt exhibit very low short-term toxicity to fish.

Key value for chemical safety assessment

Additional information