Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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
Justification for type of information:
Data is from authoritative database.

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Acute oral toxicity study of test chemical
Author:
U. S. National Library of Medicine
Year:
2018
Bibliographic source:
HSDB

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium phosphinate
EC Number:
231-669-9
EC Name:
Sodium phosphinate
Cas Number:
7681-53-0
Molecular formula:
H3O2P.Na
IUPAC Name:
Sodium hypophosphite
Test material form:
solid
Details on test material:
- Name of test material: sodium phosphinate
- IUPAC name: Sodium hypophosphite
- Molecular formula: NaO2P
- Molecular weight: 87.9778 g/mole
- Smiles notation: [Na+].[O-]P=O
- InChl: 1S/Na.H3O2P/c;1-3-2/h;3H2,(H,1,2)/q+1;/p-1
- 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:
- Fasting period before study: Fasting was done.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mg/kg body weight.
Doses:
0, 2000 and 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
Statistics:
No data

Results and discussion

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 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).
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 3 out 10 males and 6 out 10 females were found dead on day 2.
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 2000 and 5000 mg/kg, body weight gain was similar to controls.
Gross pathology:
At necropsy, red lungs and stomachs filled with a clear watery fluid were reported in those animals.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not Classified
Conclusions:
The acute oral LD50 was determined to be >5000 mg/kg in male and between 2000-5000 mg/kg bw in female, when rats were treated with the given test chemical via oral route.
Executive summary:

The acute oral toxicity study was conducted for the given test chemical according to methods similar to OPPTS 870.1100 and OECD 401 guidelines in male and female 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 (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). 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. 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, acute oral LD50 of test chemical in male rats was determined to be >5000 mg/kg and in female rats was observed in between 2000-5000 mg/kg bw.