Phosphoric acid C12-alkyl and C18-alkyl esters, potassium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

June 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Brow well fisheries limited, Hebden, Yorkshire, UK
- Length at study initiation (length definition, mean, range and SD): 5.1 cm (sd=0.6)
- Weight at study initiation (mean and range, SD): 1.54 g (sd=0.60)
- Feeding during test
- Food type: commercial trout pellets

ACCLIMATION
- Acclimation period: 13 days
- Health/mortality: zero mortality in the 7 days prior to the start of the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

14 %

pH:

7.3 - 7.8

Dissolved oxygen:

8.6 - 9.1 mg O2/L

Nominal and measured concentrations:

100 mg a.i./L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

The 96-hour LC50 based on nominal test concentrations was greater than 100 mg a.i.*/L and correspondingly the No Observed Effect Concentration (NOEC) was 100 mg a.i./L.

It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg a.i./L.

 

·        * ai = active ingredient

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test material to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-hour LC50 greater than 100 mg a.i./L. Correspondingly, the NOAC was 100 mg a.i./L.

Executive summary:

Introduction:

A study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, “Fish, Acute Toxicity Test” referenced as method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Methods:

Following a preliminary range-finding test fish were exposed, in two groups of seven, to an aqueous dispersion of the test material, at single concentration of 100 mg a.i.*/L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after start of exposure and then daily throughout the test until termination after 96 hours.

Results:

The 96-Hour LC50 based on nominal test concentrations was greater than 100 mg a.i./L and correspondingly the No Observed Effect Concentration was 100 mg a.i./L.

 

·        * ai = active ingredient

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

from 2012-02-13 to 2012-03-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples were taken after preparation of the treatments at the start and at the end of the test and were filtrated with membrane filters (pore diameter 0.45 µm). The samples were measured directly. Each sample was measured at least in duplicate.

Vehicle:

no

Details on test solutions:

A water-accommodation fraction (WAF) was prepared by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was used as test solution without previous filtration.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Hamilton Buchanan
- Source: The original animals were obtained from Umweltbundesamt (UBA), Germany. They were used for breeding and their ofspring was used for the test.
- Age at study initiation: sexually immature young fish
- Length at study initiation: 2 ± 1 cm
- Maintenance of the brood fish:
Vessels: polyethylene aquaria
Medium: chlorine-free tap water
Feeding: three times a day with warmwater fishfood and daphnia, totalling to about 1-2 % of body weight per day
Medium renewal: twice a week
Photo period: 12/12 hours, using neon tubes
Temperature: 23 ± 2 °C

FEEDING DURING TEST: no feeding during the test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

0.79 mmol/L

Test temperature:

20.8 - 24.0 °C

pH:

7.4 - 8.1

Dissolved oxygen:

7.6 - 9.0 mg/L

Conductivity:

172 µS/cm

Nominal and measured concentrations:

control 0 mg/L and treatment 100 mg/L (nominal concentration)
no measured concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria, maximal volume 10 L
- Fill volume: 7 L test solution of dilution water
- Aeration: glass tubes, frequency of bubbles 1/s
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: good quality drinking water
- Total organic carbon: 0.5 mg/L
- Pesticides: < LOD
- Chlorine: 10 mg/L
- Ca/mg ratio: 27.2 mg/L Ca, 2.8 mg/L Mg
- Intervals of water quality measurement: once a year

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 12/12 hours using neon tubes

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Mortalities were recorded daily. No abnormal behaviour of the surviving fish was observed. No mortalities were observed in the control and in the treatment groups.

Nom. Conc. In mg/L	Total of fish used	Dead fish
		24 h	48 h	72 h	96 h
		cum.	cum.	cum.	cum.
0	7	0	0	0	0
100	7	0	0	0	0

Analytical determination

The measured DOC-values of the blank controls and the treatment both lay below the limit of quantification due to the very low solubility in medium. As no quantification of the test item in the treatments was possible, the biological results were based on the nominal concentration.

Because of the poor solubility in water, the analytical determinations of the test item showed poor correlation between nominal and measured concentrations. The measured DOC values in the test solution and in the control were below the limit of detection. Therefore, the determination of the results was based on the nominal concentration. The treatment showed no toxicity. No fish died in the control. No observations were made which might cause doubts concerning the validity of the study outcome. The result of the test can be considered valid.

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of the test item on Zebrafish was determined after 96 hours. The LC50 was determined to be >100 mg/L and the NOEC was >=100 mg/L, respectively.

Executive summary:

The acute toxicity of the test item to Zebrafish was determined according to the OECD Guideline 203 and EU Council Regulation No. 440/2008 method C.1. A static test was performed as a limit test with a concentration of 100 mg/L. The test item solution was prepared as water-accomodation fraction solution. The test item was dissolved in dilution water - chlorine-free tap water with good quality. Seven test animals were exposed to the test concentration and the control, respectively, for 96 hours. Analyses of dissolved organic carbon (DOC) were made by TC/IC measurement usind carbon analyser. The measured DOC-values of the blank controls and the treatment both lay below the limit of quantification due to the very low solubility in medium, threfore, the biological results were based on the nominal concentrations. No abnormal behaviour and mortality were observed in the treatment and the control group. In conclusion, the NOEC was determined to be >=100 mg/L. The LC50 and the LC100 correspond to the nominal concentration >100 mg/L.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to section 13 for "Read-Across justification".

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

Please refer to section 13 for "Read-Across justification".

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Description of key information

Based on a weight of evidence approach using two read-across studies, the acute toxicity to fish as LD50 was determined to be >100 mg/L and the NOEC to be >=100 mg/L, respectively.

Additional information

No data on the substance itself is available. The test substance is a mixture of C12 and C18 chain phosphoric acid esters. Therefore, read-across approach to the C12 and C18 phosphoric acid esters separately was applied. Two read across studies are available assessing the short-term toxicity to fish of Phosphoric acid, dodecyl ester, potassium salt (CAS 39322-78-6) and 1-Octanol, phosphate, potassium salt (CAS 68987-29-1). These studies were used in a weight of evidence approach.

A study was performed with CAS 39322-78-6 to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss). The method followed that described in the OECD TG 203, “Fish, Acute Toxicity Test” referenced as method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). Following a preliminary range-finding test fish were exposed, in two groups of seven, to an aqueous dispersion of the test material, at single concentration of 100 mg a.i./L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after start of exposure and then daily throughout the test until termination after 96 hours. The 96-Hour LC50 based on nominal test concentrations was greater than 100 mg a.i./L and correspondingly the No Observed Effect Concentration was 100 mg a.i./L.

 

The acute toxicity of the second read-across item CAS 68987-29-1 to Zebrafish was determined according to the OECD Guideline 203 and EU Council Regulation No. 440/2008 method C.1. A static test was performed as a limit test with a concentration of 100 mg/L. The test item solution was prepared as water-accomodation fraction solution. The test item was dissolved in dilution water - chlorine-free tap water with good quality. Seven test animals were exposed to the test concentration and the control, respectively, for 96 hours. Analyses of dissolved organic carbon (DOC) were made by TC/IC measurement usind carbon analyser.The measured DOC-values of the blank controls and the treatment both lay below the limit of quantification due to the very low solubility in medium, threfore, the biological results were based on the nominal concentrations. No abnormal behaviour and mortality were observed in the treatment and the control group. In conclusion, the NOEC was determined to be >=100 mg/L. The LC50 and the LC100 correspond to the nominal concentration >100 mg/L.

As no effects for both components of the test substance in the short-term toxicity to fish studies were observed up to the limit concentration of 100 mg/L, it can be concluded that the test substance has no effect on fish up until 100 mg/L. Thus, the LC50 is determined as >100 mg/L and the NOEC as >=100 mg/L, respectively.