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Administrative data

Description of key information

Acute oral toxicity:

The acute oral median lethal dose (LD50) for the test chemical using rats was determined to be 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ammonium phosphinate (CAS no.: 7803-65-8) cannot be classified for acute oral toxicity and is classified as "Not classified"

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
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
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
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
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:
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
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
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
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).
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from database.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

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. Thus, comparing this value with the criteria of CLP regulation, Ammonium phosphinate (CAS no.: 7803-65-8) cannot be classified for acute oral toxicity and is classified as "Not classified"

Justification for classification or non-classification

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. Thus, comparing this value with the criteria of CLP regulation, Ammonium phosphinate (CAS no.: 7803-65-8) cannot be classified for acute oral toxicity and is classified as "Not classified"