Ammonium phosphinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Experimental data from various test chemicals

Justification for type of information:

Data for the target chemical is summarized based on the experimental data from various test chemicals

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from Authoritative database

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Principles of method if other than guideline:

The acute oral toxicity of test chemical was examined in rats according to methods similar to OPPTS 870.1100 and OECD 401 guidelines.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: Yes, further details are not available
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0, 2000 or 5000 mg/Kg
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Test chemical solubility
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): The test chemical was prepared in water at dose level of 0, 2000 or 5000 mg/Kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

Doses:

0, 2000 or 5000 mg/kg bw

No. of animals per sex per dose:

20 males and 10 females
- 2000 mg/kg: 10 males
- 5000 mg/kg: 10 males and 10 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 14 days following the single administration of the test item
- Necropsy of survivors performed: yes
- Other -examinations performed: Clinical signs, mortality and body weight. Animals were subjected to necropsy and gross pathology was also performed

Statistics:

No data available

Preliminary study:

Based on a previous study (not available) indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test chemical to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males).

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 3 out of 10 males rats died. 50% mortality was not observed

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - < 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 6 out 10 females were found dead at 5000 mg/Kg bw

Mortality:

- At 2000 mg/kg , no mortality occurred.
- At 5000 mg/kg, 3 out of 10 males and 6 out 10 females died on day 2.
- In the negative control groups, no deaths occurred.

Clinical signs:

- In males exposed to 2000 mg/kg, mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2.
- In males and females exposed to 5000 mg/kg, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3.
- There were no clinical signs in the negative control groups.

Body weight:

At dose levels 2000 and 5000 mg/kg, body weight gain was similar to controls and no apparent abnormalities were observed at necropsy.

Gross pathology:

Red lungs and stomachs filled with a clear watery fluid were reported in the 3 males and 6 females found dead in the 5000 mg/kg bw groups.

Other findings:

No data

Interpretation of results:

other: Not Classified

Conclusions:

The acute oral median lethal dose (LD50) for the test chemical in male rats was determined to be >5000 mg/kg and in female rats, the LD50 was considered to be 2000-5000 mg/kg bw.

Executive summary:

Acute oral toxicity of test chemical was examined in rats according to methods similar to OPPTS 870.1100 and OECD 401 guidelines. The 14 days study was performed using rats.

 

The test chemical was prepared in water and was administered by gavage under a dosage-volume of 10 mL/kg bw to groups of 10 fasted rats. Based on a previous study details indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test item to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males). Negative control groups receiving water only were included in the study. Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy and gross pathology was also performed.

 

At the dose-level of 2000 mg/kg, no mortality occurred. Mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy.

 

At the dose- level of 5000 mg/kg, 3 out 10 males and 6 out 10 females were found dead on day 2. At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals. In the surviving animals, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy.

 

Under the experimental conditions of this study, the acute oral median lethal dose (LD50) for the test chemical in male rats was determined to be >5000 mg/kg and in female rats, the LD50 was considered to be 2000-5000 mg/kg bw.

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database.

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Acute oral toxicity study was performed to determine the toxic nature of the test chemical in rats.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

Doses:

7640 mg/kg

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

- Other examinations performed: mortality

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

7 640 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

50% mortality was observed at 7640 mg/kg bw

Clinical signs:

not specified

Body weight:

not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

The acute oral median lethal dose (LD50) was considered to be 7640 mg/kg bw, when rats were treated with test chemical orally.

Executive summary:

Acute oral toxicity study of the test chemical was conducted in rat at the concentration of 7640 mg/kg bw. 50% mortality was observed at 7640 mg/kg bw. Therefore, the acute oral median lethal dose (LD50) was considered to be 7640 mg/kg bw, when rats were treated with test chemical orally.

Cross-reference 3

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database.

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Acute oral toxicity study owas performed using rats to detemine the toxic nature of the test chemical

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not specified

Doses:

5750 mg/kg

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

- Other examinations performed: mortality

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

5 750 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

Mortality:

50% mortality was observed at 5750 mg/kg bw

Clinical signs:

not specified

Body weight:

not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

The acute oral median lethal dose (LD50) was considered to be 5750 mg/kg bw, when rats were treated with test chemical orally.

Executive summary:

Acute oral toxicity study of the test chemical was conducted in rats at the concentration of 5750 mg/kg bw. 50% mortality was observed at 5750 mg/kg bw. Therefore, LD50 was considered to be 5750 mg/kg bw, when rats were treated with test chemical orally.

Data source

Reference

Reference Type:

other:

Title:

WoE of acute oral toxicty study for CAS no 7803-65-8

Author:

Sustainability Support Services (Europe) AB

Year:

2019

Bibliographic source:

WoE report, Sustainability Support Services (Europe) AB, 2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Principles of method if other than guideline:

WoE for the target CAS is summarized based on data from various test chemicals

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium phosphinate

EC Number:

232-266-0

EC Name:

Ammonium phosphinate

Cas Number:

7803-65-8

Molecular formula:

H3N.H3O2P

IUPAC Name:

ammonium phosphinate

Details on test material:

- Name of test material : Ammonium phosphinate
- Molecular formula : H4NO2P
- Molecular weight : 83.0264 g/mol
- Smiles notation : [NH4+].[O-]P=O
- InChl : 1S/H3N.H3O2P/c;1-3-2/h1H3;3H2,(H,1,2)
- Substance type: Inorganic
- Physical state: Solid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

2. TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: Yes, further details are not available
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data

3. No data

4. No data

Administration / exposure

Route of administration:

other: Oral : 2. gavage; 3. unspecified, 4. unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

2. VEHICLE
- Concentration in vehicle: 0, 2000 or 5000 mg/Kg
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Test chemical solubility
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): The test chemical was prepared in water at dose level of 0, 2000 or 5000 mg/Kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

3. No data

4. No data

Doses:

2. 0, 2000 or 5000 mg/kg bw
3. 7640 mg/kg
4. 5750 mg/Kg

No. of animals per sex per dose:

2. 20 males and 10 females
- 2000 mg/kg: 10 males
- 5000 mg/kg: 10 males and 10 females

3. No data

4. No data

Control animals:

yes

Remarks:

2. Yes, 3/4. No data

Details on study design:

2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 14 days following the single administration of the test item
- Necropsy of survivors performed: yes
- Other -examinations performed: Clinical signs, mortality and body weight. Animals were subjected to necropsy and gross pathology was also performed

3. - Other examinations performed: mortality

4. - Other examinations performed: mortality

Statistics:

No data available

Results and discussion

Preliminary study:

2. Based on a previous study (not available) indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test chemical to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males).

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

2. - At 2000 mg/kg , no mortality occurred.
- At 5000 mg/kg, 3 out of 10 males and 6 out 10 females died on day 2.
- In the negative control groups, no deaths occurred.

3. 50% mortality was observed at 7650 mg/Kg

4. 50% mortality was observed at 5750 mg/Kg

Clinical signs:

2. - In males exposed to 2000 mg/kg, mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2.
- In males and females exposed to 5000 mg/kg, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3.
- There were no clinical signs in the negative control groups.

3. No data

4. No data

Body weight:

2. At dose levels 2000 and 5000 mg/kg, body weight gain was similar to controls and no apparent abnormalities were observed at necropsy.

3. No data

4. No data

Gross pathology:

2. Red lungs and stomachs filled with a clear watery fluid were reported in the 3 males and 6 females found dead in the 5000 mg/kg bw groups.

3. No data

4. No data

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

other: Not Classified

Conclusions:

The acute oral median lethal dose (LD50) for the test chemical using rats was determined to be 2000 mg/kg bw.

Executive summary:

Data available from the various test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:

Acute oral toxicity of test chemical was examined in rats according to methods similar to OPPTS 870.1100 and OECD 401 guidelines. The 14 days study was performed using rats. The test chemical was prepared in water and was administered by gavage under a dosage-volume of 10 mL/kg bw to groups of 10 fasted rats. Based on a previous study details indicating that LD50 was greater than 1000 mg/kg in male rats, the first dose of the test item to be tested in male rats was 2000 mg/kg. The other tested dose-level administered was 5000 mg/kg (1 group of females, 1 group of males). Negative control groups receiving water only were included in the study. Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy and gross pathology was also performed. At the dose-level of 2000 mg/kg, no mortality occurred. Mild depression and piloerection were observed from day 1 (1 hour after dosing) to day 2. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. At the dose- level of 5000 mg/kg, 3 out 10 males and 6 out 10 females were found dead on day 2. At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals. In the surviving animals, mild depression and piloerection were observed from day 1 (immediately after dosing) to day 3. Body weight gain was similar to controls and no apparent abnormalities were observed at necropsy. Under the experimental conditions of this study, the acute oral median lethal dose (LD50) for the test chemical in male rats was determined to be >5000 mg/kg and in female rats, the LD50 was considered to be 2000-5000 mg/kg bw.

Acute oral toxicity study of the test chemical was conducted in rat at the concentration of 7640 mg/kg bw. 50% mortality was observed at 7640 mg/kg bw. Therefore, the acute oral median lethal dose (LD50) was considered to be 7640 mg/kg bw, when rats were treated with test chemical orally.

Acute oral toxicity study of the test chemical was conducted in rats at the concentration of 5750 mg/kg bw. 50% mortality was observed at 5750 mg/kg bw. Therefore, LD50 was considered to be 5750 mg/ kg bw, when rats were treated with test chemical orally.

Based on the data available and applying weight of evidence approach, the acute oral median lethal dose (LD50) for the test chemical using rats was determined to be 2000 mg/kg bw.