Orthosulfamuron

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:

key study

Study period:

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)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: ASTM Standard E729-88a (1994)

GLP compliance:

yes

Specific details on test material used for the study:

Test material:
IR5878
Batch number: G 009/02
Purity: 98.56 %

Test animals:
Species and Strain: Rainbow trout (Oncorhynchus mykiss)
Age: juveniles
Body weight: 0.36 ÷ 1.3 g (body wet weight); Length: 3.8 ÷ 5.1 cm (end of test)
Housing: 10 animals/test chamber (when treatment started).
Feed: during the holding period the fish were fed daily a commercially-prepared diet. They were not fed during the acclimation period or during the test.

Environmental conditions:
Water temperature: 12 ± 2°C; pH water: 8.3 ÷ 8.7; Dissolved oxygen: ≥ 7.8 mg/L (72% of saturation)
Light: photoperiod of 16 hours of light and 8 hours of darkness (a 30-minute transition period of low light intensity was provided at the beginning and end of the 16-hour light period to avoid sudden changes in lighting).

Analytical monitoring:

yes

Details on sampling:

Method:
A study was performed to determine the acute toxicity of IR5878 to Rainbow trout (Oncorhynchus mykiss) during a 96-hour exposure period under static test conditions.
Rainbow trout were exposed to a geometric series of five test concentrations and a negative control (well water). Two replicate test chambers were maintained in each treatment and control group, with 10 rainbow trout each chamber, for a total of 20 rainbow trout per test concentration. Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination.
Observations of mortality and other signs of toxicity were made approximately 3, 24, 48, 72 and 96 hours after test initiation. Cumulative percent mortality observed in the treatment groups was used to estimate LC50 values at 24, 48, 72 and 96 hours. The no mortality concentration and the no-observed-effect-concentration (NOEC) were determined by visual interpretation of the mortality and biological observation data.

Findings
Samples collected at test initiation and at 48-hours had measured concentrations that ranged from 98 to 105% of nominal concentrations. Samples collected at test termination had measured concentrations that ranged from 99 to 107% of nominal concentrations. When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 16, 26, 44, 74 and 122 mg/L, representing 100, 100, 102, 103 and 102% of nominal concentrations, respectively.
All Rainbow trout in the negative control group and in the treatment groups appeared normal throughout the test, with no mortalities or overt signs of toxicity observed.

Details on test solutions:

Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Test animals:
Species and Strain: Rainbow trout (Oncorhynchus mykiss)
Age: juveniles
Body weight: 0.36 ÷ 1.3 g (body wet weight); Length: 3.8 ÷ 5.1 cm (end of test)
Housing: 10 animals/test chamber (when treatment started).
Feed: during the holding period the fish were fed daily a commercially-prepared diet. They were not fed during the acclimation period or during the test.

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

Water temperature: 12 ± 2°C

pH:

pH water: 8.3 ÷ 8.7

Dissolved oxygen:

Dissolved oxygen: ≥ 7.8 mg/L (72% of saturation)

Salinity:

well water

Nominal and measured concentrations:

When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 16, 26, 44, 74 and 122 mg/L, representing 100, 100, 102, 103 and 102% of nominal concentrations, respectively.

Details on test conditions:

Rainbow trout were exposed to a geometric series of five test concentrations and a negative control (well water). Two replicate test chambers were maintained in each treatment and control group, with 10 rainbow trout each chamber, for a total of 20 rainbow trout per test concentration. Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 122 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

All Rainbow trout in the negative control group and in the treatment groups appeared normal throughout the test, with no mortalities or overt signs of toxicity observed.

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LC50 value for the Rainbow trout fish exposed to IR5878 was greater than 122 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Rainbow trout exposed to IR5878 at concentrations up to 122 mg/L. The 96-hour no mortality concentration and the NOEC were 122 mg/L.

Executive summary:

Findings

Samples collected at test initiation and at 48-hours had measured concentrations that ranged from 98 to 105% of nominal concentrations. Samples collected at test termination had measured concentrations that ranged from 99 to 107% of nominal concentrations. When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 16, 26, 44, 74 and 122 mg/L, representing 100, 100, 102, 103 and 102% of nominal concentrations, respectively.

All Rainbow trout in the negative control group and in the treatment groups appeared normal throughout the test, with no mortalities or overt signs of toxicity observed.

 

Conclusions

The 96-hour LC₅₀value for the Rainbow trout fish exposed to IR5878 was greater than 122 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Rainbow trout exposed to IR5878 at concentrations up to 122 mg/L. The 96-hour no mortality concentration and the NOEC were 122 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: ASTM Standard E729-88a (1994)

Principles of method if other than guideline:

Deviations: length of fish was greater than the range recommended by OECD 203 (3.4-4.5 cm instead of 1-3 cm). Considering the type of the study, this deviation is considered to have not affected the reliability of results.

GLP compliance:

yes

Specific details on test material used for the study:

Test material:
IR5878
Batch number: G 009/02
Purity: 98.56 ± 0.19 %

Details on sampling:

Method:
A study was performed to determine the acute toxicity of IR5878 to Bluegill (Lepomis macrochirus) during a 96-hour exposure period under static test conditions.
Bluegill were exposed to a geometric series of five test concentrations and a negative control (well water). Two replicate test chambers were maintained in each treatment and control group, with 10 Bluegill each chamber, for a total of 20 Bluegill per test concentration. Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination.
Observations of mortality and other signs of toxicity were made approximately 18, 24, 48, 72 and 96 hours after test initiation. Cumulative percent mortality observed in the treatment groups was used to estimate LC50 values at 24, 48, 72 and 96 hours. The no mortality concentration and the no-observed-effect-concentration (NOEC) were determined by visual interpretation of the mortality and biological observation data.

Findings
Samples collected at test initiation, at 48 hours and at test termination had measured concentrations that ranged from 106 to 121% of nominal concentrations (with the exception of one replicate in the 26 mg/L treatment group, which had measured concentrations of 148 ÷ 152% of nominal). When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 18, 34, 46, 84 and 142 mg/L, representing 113, 131, 107, 117 and 118% of nominal concentrations, respectively.
All Bluegill in the negative control group and in the treatment groups appeared normal throughout the test, with no mortalities or overt signs of toxicity observed.

Details on test solutions:

Method:
A study was performed to determine the acute toxicity of IR5878 to Bluegill (Lepomis macrochirus) during a 96-hour exposure period under static test conditions.
Bluegill were exposed to a geometric series of five test concentrations and a negative control (well water). Two replicate test chambers were maintained in each treatment and control group, with 10 Bluegill each chamber, for a total of 20 Bluegill per test concentration. Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination.
Observations of mortality and other signs of toxicity were made approximately 18, 24, 48, 72 and 96 hours after test initiation. Cumulative percent mortality observed in the treatment groups was used to estimate LC50 values at 24, 48, 72 and 96 hours. The no mortality concentration and the no-observed-effect-concentration (NOEC) were determined by visual interpretation of the mortality and biological observation data.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

Test animals:
Species and Strain: Bluegill (Lepomis macrochirus)
Age: juveniles
Body weight: 0.37 ÷ 1.1 g (body wet weight); Length: 3.4 ÷ 4.5 cm (end of test)
Housing: 10 animals/test chamber (when treatment started).
Feed: during the holding period the fish were fed daily a commercially-prepared diet. They were not fed during the acclimation period or during the test.
Deviations: length of fish was greater than the range recommended by OECD 203 (3.4-4.5 cm instead of 1-3 cm). Considering the type of the study, this deviation is considered to have not affected the reliability of results.
Source: Osage Catfisheries, Inc. Osage Beach, Missouri 65065

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

Water temperature: 22 ± 1°C

pH:

pH water: 8.2 ÷ 8.7

Dissolved oxygen:

Dissolved oxygen: ≥ 6.3 mg/L (73% of saturation)

Nominal and measured concentrations:

Nominal test concentrations were 16, 26, 43, 72 and 120 mg IR5878/L. Mean measured test concentrations were determined from samples of test water collected from each treatment and control group at test initiation, at the approximate mid-point of the test and at test termination. Samples collected at test initiation, at 48 hours and at test termination had measured concentrations that ranged from 106 to 121% of nominal concentrations (with the exception of one replicate in the 26 mg/L treatment group, which had measured concentrations of 148 ÷ 152% of nominal). When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 18, 34, 46, 84 and 142 mg/L, representing 113, 131, 107, 117 and 118% of nominal concentrations, respectively.

Details on test conditions:

Environmental conditions:
Water temperature: 22 ± 1°C; pH water: 8.2 ÷ 8.7; Dissolved oxygen: ≥ 6.3 mg/L (73% of saturation)
Light: photoperiod of 16 hours of light and 8 hours of darkness (a 30-minute transition period of low light intensity was provided at the beginning and end of the 16-hour light period to avoid sudden changes in lighting).
Housing: 10 animals/test chamber (when treatment started).
Feed: during the holding period the fish were fed daily a commercially-prepared diet. They were not fed during the acclimation period or during the test.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 142 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 142 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Findings
Samples collected at test initiation, at 48 hours and at test termination had measured concentrations that ranged from 106 to 121% of nominal concentrations (with the exception of one replicate in the 26 mg/L treatment group, which had measured concentrations of 148 ÷ 152% of nominal). When measured concentrations of the samples collected throughout the test were averaged, the mean measured test concentrations were 18, 34, 46, 84 and 142 mg/L, representing 113, 131, 107, 117 and 118% of nominal concentrations, respectively.
All Bluegill in the negative control group and in the treatment groups appeared normal throughout the test, with no mortalities or overt signs of toxicity observed.

Validity criteria fulfilled:

yes

Conclusions:

Conclusions
The 96-hour LC50 value for the Bluegill fish exposed to IR5878 was greater than 142 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Bluegill exposed to IR5878 at concentrations up to 142 mg/L. The 96-hour no mortality concentration and the NOEC were 142 mg/L

Executive summary:

Executive summary

A study was performed to determine the acute toxicity of IR5878 to Bluegill (Lepomis macrochirus) during a 96-hour exposure period under static test conditions. Bluegill were exposed to a geometric series of five test concentrations (16, 26, 43, 72 and 120 mg IR5878/L) and a negative control (well water).

The 96-hour LC₅₀value for the Bluegill fish exposed to IR5878 was greater than 142 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Bluegill exposed to IR5878 at concentrations up to 142 mg/L. The 96-hour no mortality concentration and the NOEC were 142 mg/L.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/69/EEC, Annex Part C, C.1 (December 29, 1992)

GLP compliance:

yes

Specific details on test material used for the study:

Test material:
IR5878
Batch number: FCF/T/168-00 (ex 20525/03/9)
Purity: 98.54 ± 0.51 %

Details on sampling:

Method:
A study was performed to evaluate the acute toxicity of IR5878 to Zebra fish.
Groups of 7 fish were introduced into each aquarium in a random order. The fish were exposed in a static test to an aqueous test medium containing IR5878 at the nominal concentration of 100 mg/L (limit test) in 9-L glass aquarium with 5 litres test medium. In addition, one control group was tested. The duration of the exposure was 96 hours.
The test fish were observed after approximately 2, 24, 48, 72 and 96 hours test duration for symptoms of intoxication and mortality.

Findings
On day 2 and on day 4 of exposure samples were taken in duplicate out of the test medium of nominal 100 mg/L and the control, and IR5878 concentrations were measured to be in the range from 94% to 101% of the nominal value. Therefore, all reported results are related to nominal concentration of IR5878.
Biological results: in the control and in the test medium of 100 mg/L all fish survived until the end of the test and no signs of intoxication were observed.

Details on test solutions:

Environmental conditions:
Water temperature: 21°C; pH water: 7.1 ÷ 8.0; Dissolved oxygen: ≥ 8.8 mg/L
Light: 16 hours of light and 8 hours of dark.

Test organisms (species):

other: Zebra Fish (Brachydanio rerio)

Details on test organisms:

Test animals:
Species and Strain: Male and Female Zebra fish (Brachydanio rerio)
Age: juveniles
Body weight: 0.40 ± 0.07 g (mean body wet weight); Length: 3.38 ± 0.12 cm
Housing: 7 animals/aquarium.
Feed: during the holding period until one day before test start the fish were fed with a commercial fish diet. They were not fed during the test.

Total exposure duration:

96 h

Test temperature:

Water temperature: 21°C

pH:

pH water: 7.1 ÷ 8.0;

Dissolved oxygen:

Dissolved oxygen: ≥ 8.8 mg/L

Nominal and measured concentrations:

On day 2 and on day 4 of exposure samples were taken in duplicate out of the test medium of nominal 100 mg/L and the control, and IR5878 concentrations were measured to be in the range from 94% to 101% of the nominal value. Therefore, all reported results are related to nominal concentration of IR5878.

Details on test conditions:

Environmental conditions:
Water temperature: 21°C; pH water: 7.1 ÷ 8.0; Dissolved oxygen: ≥ 8.8 mg/L
Light: 16 hours of light and 8 hours of dark.
Housing: 7 animals/aquarium.

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

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)

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Findings
On day 2 and on day 4 of exposure samples were taken in duplicate out of the test medium of nominal 100 mg/L and the control, and IR5878 concentrations were measured to be in the range from 94% to 101% of the nominal value. Therefore, all reported results are related to nominal concentration of IR5878.
Biological results: in the control and in the test medium of 100 mg/L all fish survived until the end of the test and no signs of intoxication were observed.

Validity criteria fulfilled:

yes

Conclusions:

Conclusions
The 96-hour NOEC and the 96-hour LC0 of IR5878 to Zebra fish were determined to be at least 100 mg/L. The 96-hour LOEC , the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L.

Executive summary:

Executive summary

A study was performed to evaluate the acute toxicity of IR5878 to Zebra fish. Groups of 7 fish were exposed in a static test for 96 hours to an aqueous test medium containing IR5878 at the nominal concentration of 100 mg/L (limit test).

The 96-hour NOEC and the 96-hour LC₀of IR5878 to Zebra fish were determined to be at least 100 mg/L. The 96-hour LOEC , the 96-hour LC₅₀and the 96-hour LC₁₀₀were clearly higher than 100 mg/L.

Description of key information

The 96-hour LC50 value for the Rainbow trout fish exposed to IR5878 was greater than 122 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Rainbow trout exposed to IR5878 at concentrations up to 122 mg/L. The 96-hour no mortality concentration and the NOEC were 122 mg/L.

The 96-hour NOEC and the 96-hour LC0 of IR5878 to Zebra fish were determined to be at least 100 mg/L. The 96-hour LOEC , the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L.

The 96-hour LC50 value for the Bluegill fish exposed to IR5878 was greater than 142 mg/L, the highest concentration tested. No mortalities or toxic effects were observed in Bluegill exposed to IR5878 at concentrations up to 142 mg/L. The 96-hour no mortality concentration and the NOEC were 142 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

121 mg/L