Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

11/93

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Please find the Justification attached to Chapter 13.2.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: Verlängerter Toxizitätstest beim Zebrabärbling Brachydanio rerio (Schwellenkonzentration der letalen und anderer Wirkungen; NOEC, min. 14 Tage) Umweltbundesamt Berlin, Stand 01.02.1984

Deviations:

yes

Remarks:

, Cited in the study report: conditions of temperature, but not relevant for test result

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)

Deviations:

yes

Remarks:

, Cited in the study report: conditions of temperature, but not relevant for test result

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

- applikations method: direct weighing
- solution water and dilution water: synthetic fresh water according to ISO

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio; Zebra danio
- Source: West-Aquarium (Bad Lauterberg; Germany)
- Length: 2.5 - 3.5 cm
- Mortality during pre-exposure to synthetic fresh water according to ISO: < 2%
- Medical pre-treatment: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

14 d

Post exposure observation period:

NA (The fishes were scarified after 14 days of exposure and then the length and bodyweight were determined).

Hardness:

12.8 - 15.4°dH

Test temperature:

ca. 21°C (+/-2°C)

pH:

7.8 mg/L - 9.6 mg/L

Dissolved oxygen:

7.8 mg/L - 9.6 mg/L

Salinity:

according to ISO

Nominal and measured concentrations:

Nominal concentrations in mg/L.: 10; 31.6; 100; 316; 1000
Measured concentrations in mg/L: 10-12; 30-34; 100-109; 309-337; 994-1086

Details on test conditions:

TEST SYSTEM
- Photoperiod (hrs dark / hrs light): 8 / 16 hours rhythm
- Test medium: 5 L, aerated
- Vehicle: no
- No. of organisms per vessel and concentration: 10

Reference substance (positive control):

not required

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Details on results:

A LC50 (96h) of > 1042 mg/L was derived from the available prolonged toxicity study in fish over 14 days (result: LC50 (21d) > 1042 mg/L).
No mortality was recorded for this prolonged toxicity study in 10 fishes (species: zebra danio) per dose level. Behaviour and development of length and body weight was comparable to those of the controls.

Validity criteria fulfilled:

yes

Conclusions:

A LC50 (96h) of > 1042 mg/L was concluded from the results of the prolonged toxicity study in fish.

Executive summary:

As there is no data available for tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate a read-across approach with the corresponding parent acid 2-phosphonobutane-1,2,4-tricarboxylic acid is proposed.

In aqueous media, tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate and 2-phosphono-butane-1,2,4-tricarboxylic acid dissociate into the corresponding anion (2-phosphonatobutane-tricarboxylate ion) and the sodium ion and hydrogen ion (proton), respectively. Fate, behavior and the ecotoxicological properties of 2-phosphonobutane-1,2,4-tricarboxylic acid and its tetrasodium salt are thought to be an effect of the phosphonato-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in environmental systems and have no relevant ecotoxic properties in low concentrations.

Therefore a read-across between tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate and 2-phosphonobutane-1,2,4-tricarboxylic acid is justified.

A LC50(96h) of > 1042 mg/L was concluded from the results of the available prolonged toxicity study in fish ( species: zebra danio) over 14 days. Thus, the LC50(96h) is higher than the concentration of the limit test (100 mg/L). No further testing (in respect of classification and labelling etc.) is required.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11/93

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: Verlängerter Toxizitätstest beim Zebrabärbling Brachydanio rerio (Schwellenkonzentration der letalen und anderer Wirkungen; NOEC, min. 14 Tage) Umweltbundesamt Berlin, Stand 01.02.1984

Deviations:

yes

Remarks:

, Cited in the study report: conditions of temperature, but not relevant for test result

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)

Deviations:

yes

Remarks:

, Cited in the study report: conditions of temperature, but not relevant for test result

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

- applikations method: direct weighing
- solution water and dilution water: synthetic fresh water according to ISO

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Danio rerio; Zebra danio
- Source: West-Aquarium (Bad Lauterberg; Germany)
- Length: 2.5 - 3.5 cm
- Mortality during pre-exposure to synthetic fresh water according to ISO: < 2%
- Medical pre-treatment: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

14 d

Post exposure observation period:

NA (The fishes were scarified after 14 days of exposure and then the length and bodyweight were determined).

Hardness:

12.8 - 15.4°dH

Test temperature:

ca. 21°C (+/-2°C)

pH:

7.8 mg/L - 9.6 mg/L

Dissolved oxygen:

7.8 mg/L - 9.6 mg/L

Salinity:

according to ISO

Nominal and measured concentrations:

Nominal concentrations in mg/L.: 10; 31.6; 100; 316; 1000
Measured concentrations in mg/L: 10-12; 30-34; 100-109; 309-337; 994-1086

Details on test conditions:

TEST SYSTEM
- Photoperiod (hrs dark / hrs light): 8 / 16 hours rhythm
- Test medium: 5 L, aerated
- Vehicle: no
- No. of organisms per vessel and concentration: 10

Reference substance (positive control):

not required

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 042 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

behaviour

Remarks on result:

other: No remarks

Details on results:

A LC50 (96h) of > 1042 mg/L was derived from the available prolonged toxicity study in fish over 14 days (result: LC50 (21d) > 1042 mg/L).
No mortality was recorded for this prolonged toxicity study in 10 fishes (species: zebra danio) per dose level. Behaviour and development of length and body weight was comparable to those of the controls.

Validity criteria fulfilled:

yes

Conclusions:

A LC50 (96h) of > 1042 mg/L was concluded from the results of the prolonged toxicity study in fish.

Executive summary:

A LC50(96h) of > 1042 mg/L was concluded from the results of the available prolonged toxicity study in fish ( species: zebra danio) over 14 days. Thus, the LC50(96h) is higher than the concentration of the limit test (100 mg/L). No further testing (in respect of classification and labelling etc.) is required.

Description of key information

As there is no data available for tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate , results of the parent acid, 2-phosphonobutane-1,2,4-tricarboxylic acid are taken into account for this endpoint.
A LC50 (96h) of > 1042 mg/L was concluded from the results of the available prolonged toxicity study in fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 1 042 mg/L

Additional information

As there is no data available for tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate a read-across approach with the corresponding parent acid 2-phosphonobutane-1,2,4-tricarboxylic acid is proposed.

In aqueous media, tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate and 2-phosphono-butane-1,2,4-tricarboxylic acid dissociate into the corresponding anion (2-phosphonatobutane-tricarboxylate ion) and the sodium ion and hydrogen ion (proton), respectively. Fate, behavior and the ecotoxicological properties of 2-phosphonobutane-1,2,4-tricarboxylic acid and its tetrasodium salt are thought to be an effect of the phosphonato-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in environmental systems and have no relevant ecotoxic properties in low concentrations.

Therefore, a read-across between tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate and 2-phosphonobutane-1,2,4-tricarboxylic acid is justified.

 

Prolonged toxicity of 2-phosphonobutane-1,2,4-tricarboxylic acid to fish (Danio rerio) has been tested under semistatic conditions in accordance to OECD Guideline 204 for an exposure period of 14 days. No mortality was recorded for this prolonged toxicity study in 10 fishes (species: Danio rerio) per dose level. Behaviour and development of length and body weight was comparable to those of the controls. A NOEC of >/= 1042 mg/l is obtained in this test. The result is interpreted as 14 d-LC50 of > 1042 mg/l referring to measured concentrations, as the test concentrations were confirmed by analytical monitoring using ion chromatography.

This toxicity study is classified as acceptable and satisfies the guideline requirements for the toxicity study to fish (Danio rerio).