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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Methods for Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians, USEPA, 1975
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not applicable
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: the test substance was added directly into the each jar and mixed by stirring

- Controls: dilution water
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM

- Common name: rainbow trout

- Source: Fish were obtained from a commercial fish hatchery in Washington, USA

- Length at study initiation (length definition, mean, range and SD): mean length of 33 mm.

- Weight at study initiation (mean and range, SD): mean wet weight of 1.9 grams at time of study

- Method of breeding: not reported

- Feeding during test: no


ACCLIMATION

- Acclimation period: 48 h

- Acclimation conditions (same as test or not): same as test

- Type and amount of food: animals were not fed during acclimation period

- Health during acclimation (any mortality observed): 0%
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
35 mg/L CaCO3
Test temperature:
Water temperature was maintained at 12 deg C.
pH:
The pH of the test media was not reported. However a test was also conducted with Icatlurus punctatus in similar test conditions (higher temperature) and higher test concentrations, which reported a pH range of 7.0-8.2.
Dissolved oxygen:
50-99% saturation. The DO is below the recommended OECD level of 60%.
Nominal and measured concentrations:
Nominal test concentrations were 576, 432, 324, 252, and 180 mg/l as active acid. 
Details on test conditions:
TEST SYSTEM

- Test vessel: jars

- Material, size, headspace, fill volume: 19 L glass jars filled with 15L test medium

- Aeration: no

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 3

- No. of vessels per control (replicates): 3


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: well water

- Culture medium different from test medium: same

- Intervals of water quality measurement: DO and temperature were measured at 0, 48 and 96 hours in the highest, middle and lowest test concentration exposures and found to be acceptable. 


OTHER TEST CONDITIONS

- Adjustment of pH: not reported

- Photoperiod: not reported

- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality every 24 h


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.35

- Range finding study: yes, details not provided
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 180 - ca. 252 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
180 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Reported statistics and error estimates:
LC50 values and 95% confidence intervals determined by regression analysis of concentrations expressed as logarithms and mortality expressed as probits.
Sublethal observations / clinical signs:

Result expressed as nominal concentration. Properties of the test  substance and evidence from other studies (where concentrations were measured) indicate that nominal and measured concentrations are likely to be in good agreement.

Percentage mortality at each nominal test concentration:

 Concentration (mg/L)  Mortality at 96 h (%)
 Control
180 
252  100 
324  100 
432  100 
576  100 



24 hr LC50: 252 (203-313) mg/L 
48 hr LC50: >180<252 mg/L

Validity criteria fulfilled:
no
Remarks:
DO was low
Conclusions:
A reliable 96 h LC50 value of 180-252 mg/L has been determined for the effects of the test substance on the mortality of the freshwater fish Salmo gairdneri (new name: Oncorhynchus mykiss). The results should however be treated with caution as the DO levels decreased to 50%, while the concentrations at which this occurred are not reported. The result is considered valid as the controls mortality was 0%.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Methods for Acute Toxicity Tests with Fish, Macroinvertebrates, and Amphibians, USEPA, 1975
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Deviations:
not applicable
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: appropriate amounts of test substance were directly added to the vessels

- Controls: dilution water only
Test organisms (species):
Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM

- Common name: sheepshead minnow

- Source: collected from stocked ponds at the testing laboratory 

- Length at study initiation (length definition, mean, range and SD): 15-20 mm standard length

- Method of breeding: not reported


ACCLIMATION

- Acclimation period: a minimum of 7 days before testing

- Acclimation conditions (same as test or not): not reported (only "acclimation to laboratory conditions" reported)

- Type and amount of food: not reported

- Health during acclimation (any mortality observed): <1%
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
Water temperature was maintained at 20 +/- 1 degree C.
pH:
The pH of the test media ranged between 6.7 and 8.3
Dissolved oxygen:
>= 58% saturation for all concentrations and control
Salinity:
25 parts per thousand
Nominal and measured concentrations:
Nominal test concentrations were 1000, 10000, 18000, 32000 and 56000 ml/l (ppm).
Details on test conditions:
TEST SYSTEM

- Test vessel: jars

- Type (delete if not applicable): open

- Material, size, headspace, fill volume: Testing was conducted in 19 litre uncovered glass jars containing 15 litres of test medium.

- Aeration: no

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1



TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Filtered natural sea water.

- Intervals of water quality measurement: DO and pH were measured during the study and remained within acceptable limits


OTHER TEST CONDITIONS

- Adjustment of pH: not reported

- Photoperiod: not reported

- Light intensity: not reported


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, every 24 h


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 2 and 10

- Range finding study: not reported
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6 435 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Reported statistics and error estimates:
Test concentrations were converted to logarithms and corresponding percentage mortalities to probits. LC50 values were then determined by linear regression.
Sublethal observations / clinical signs:

Table 1. Mortality of fish during 96 h exposure.

 Nominal concentration (u/l; ppm)     Mortality (%)      
 24 h  48 h  96 h
 Control  0  0  0
 1 000  0  0  0
 10 000  0  0  0
 18 000  0  10  10
 32 000  60  60  60
 56 000  100  100  100

Result expressed as nominal concentration. Properties of the test substance and evidence from other studies (where
concentrations were measured) indicate that nominal and measured concentrations are likely to be in good agreement.

24 hr LC50: 5377 mg/l (30,299 ppm)


48 hr LC50:

5377 mg/l (30,299 ppm)

96 hr LC50: 5377 mg/l (30,299 ppm)

The results reported have been corrected for active acid content (18%) and density (1.18).

Validity criteria fulfilled:
yes
Conclusions:
A reliable 96 h LC50 value of 6435 mg active acid/l has been determined for the effects of DTPMP acid towards the mortality of the marine fish Cyprinodon variegatus.
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to Annex 4 of the CSR and IUCLID Section 13 for justification of read-across within the DTPMP category.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 180 - ca. 250 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: EG&G (1976a)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6 435 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: EG&G (1976b)

Description of key information

There are no test data for DTPMP-xNH4, therefore data have been read-across from DTPMP-H and its sodium salts.

96 h LC50 ca. 180 - ca. 252 mg active acid/L (r-a) Salmo gairdneri (new name: Oncorhynchus mykiss)

96 h LC50 6435 mg active acid/L (r-a) Cyprinodon variegatus

Ammonia: 96-hour LC50 0.068 mg NH3-N/L, Oncorhynchus gorbuscha

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
ca. 180 - ca. 252 mg/L
Fresh water fish
Dose descriptor:
LC50
Remarks:
toxicity data for ammonia
Effect concentration:
0.068 mg/L

Marine water fish

Marine water fish
Dose descriptor:
LC50
Effect concentration:
6 435 mg/L

Additional information

DTPMP-xNH4 will dissociate when it is released into aqueous environments to yield DTPMP and ammonia. No data is available for DTPMP-xNH4, therefore data have been read-across from DTPMP-H and DTPMP-xNa.

Freshwater

Data on short term toxicity to freshwater fish are available for DTPMP Na salts (5-7Na and xNa) and DTPMP acid.

A reliable 96 h LC50value of ca. 180 - ca. 252, (ca. 216 mg/L) has been determined for the effects of DTPMP-H on the mortality of the freshwater fish Salmo gairdneri (new name: Oncorhynchus mykiss) (EG&G 1976a). The dissolved oxygen levels decreased down to 50%, while the concentrations at which this occurred are not reported, the test is considered valid as the mortality in the controls was 0%. This is the lowest reliable LC50 value and has been selected as key. The study was conducted on a neutralised form (pH 7) of DTPMP acid.

 

Other short-term toxicity studies for DTPMP Na salts (5-7Na and xNa) reported freshwater LC50 values in the range >262 to 5372 mg active acid/L (ABC, 1987; Inveresk, 1982; Gledhill and Feijtel, 1992). These studies indicate the very low short-term toxicity of DTPMP towards fish.

Marine

No reliable data on short term toxicity of DTPMP Na salts to marine fish are available. However, a reliable 96 h LC50 value of 6435 mg active acid/l has been determined for the effects of DTPMP acid towards the mortality of the marine fish Cyprinodon variegatus (EG&G 1976b).

Ammonia: A 96-hour LC50 value of 0.068 mg NH3-N/L for the effects of unionised ammonia on Oncorhynchus gorbuscha (Rice and Bailey, 1980). The value is equivalent to 0.083 mg NH3/L. The study was reviewed in the report: Environment Agency Proposed EQS for Water Framework Directive Annex VIII Substances: Ammonia (unionised) 2007 (EA, 2007).

DTPMP-xNH4 will dissociate as it is released into the aquatic environment and it is therefore necessary to assess the hazard properties and derive PNECs for DTPMP and ammonia separately. For hazard classification, DTPMP-xNH4 has been assessed based on the available aquatic data for the whole substance (based on read-across data from the ammonium salt of ATMP, a structurally analogous substance).

The influence of the ammonium salt is discussed in IUCLID Section 6.0 Ecotoxicological Information and Section 7.0 of the CSR.

The acid and salts in the DTPMP category are freely soluble in water and, therefore, the DTPMP anion is fully dissociated from its cations when in solution. Under any given conditions, the degree of ionisation of the DTPMP species is determined by the pH of the solution. At a specific pH, the degree of ionisation is the same regardless of whether the starting material was DTPMP-H, DTPMP (1-3Na), DTPMP (5-7Na), DTPMP (4-8K), DTPMP (xNH4) or another salt of DTPMP.

 

Therefore, when a salt of DTPMP is introduced into test media or the environment, the following is present (separately):

  1. DTPMP is present as DTPMP-H or one of its ionised forms. The degree of ionisation depends upon the pH of the media and not whether DTPMP-H, DTPMP (1-3Na), DTPMP (5-7Na), DTPMP (4-8K), DTPMP (xNH4), or another salt was used for testing.
  2. Disassociated ammonium, potassium or sodium cations. The amount of ammonium, potassium or sodium present depends on which salt was added.
  3. Divalent and trivalent cations have much higher stability constants for binding with DTPMP than the sodium, potassium or ammonium ions so would preferentially replace them. These ions include calcium (Ca2+), magnesium (Mg2+) and iron (Fe3+). Therefore, the presence of these in the environment or in biological fluids or from dietary sources would result in the formation of DTPMP-dication (e.g. DTPMP-Ca, DTPMP-Mg) and DTPMP-trication (e.g. DTPMP-Fe) complexes in solution, irrespective of the starting substance/test material.

In this context, for the purpose of this assessment, read-across of data within the DTPMP Category is considered to be valid.