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EC number: 231-669-9 | CAS number: 7681-53-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1984-05-15 to 1984-05-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable guideline study with acceptable restrictions. Methodology used is similar to OECD guideline 402 and guideline OPPTS 870.1200 (limit test) with deviations (less than 5 animals tested). No details on experimental conditions. Only raw data reported.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- less than 5 animals tested with intact skin
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Reliability scoring based on 1987 guideline for test n°402
- Deviations:
- yes
- Remarks:
- less than 5 animals tested with intact skin
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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 phosphinate
- Reference substance name:
- Sodium hypophosphite
- IUPAC Name:
- Sodium hypophosphite
- Details on test material:
- - Name of test material: Sodium hypophosphite, sodium hypophosphite monohydrate
- Analytical purity: 86 % (expressed in anhydrous form)
- Impurities: Phosphorous acid Anh. (NaH2PO2) 0.44 %, iron (Fe) 2.3 ppm, Heavy metals (Pb) 2 ppm, Citric acid 0.22 %
- Purity test date: 1981-11-05
- Lot/batch No.: 106, 1981-10-29
- Other: pH= 4.7
No more data available
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:
Control rabbits mean weight: 2033 grams
Dosed rabbits mean weight: 1798 grams
For details: see table 2 in free text of results and discussions
IN-LIFE DATES: From: 1984-05-15 to 1984-05-29
No more data available
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied: 2000 mg/kg body weight
No more data available - Duration of exposure:
- 24 hours
- Doses:
- One dose at 2000 mg/kg (limit dose)
- No. of animals per sex per dose:
- - Negative controls: 2 males and 2 females with for each sex 1 with abraded skin and 1 with intact skin
- 2000 mg/kg bw: 5 males (3 of which with abraded skin ) and 5 females (2 of which with abraded skin) - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7 and 14 days after exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology and behaviour - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No deaths were observed during the study.
cf table 1 in results and discussions free text - Clinical signs:
- other: No systemic clinic signs were observed during the study at the dose-levels of 2000 mg/kg. Moderate erythema and mild to moderate oedema were observed on removal of the dressing. These local reactions cleared within 24 hours. There were no effects in t
- Gross pathology:
- No abnormalities were observed at macroscopic examination.
Any other information on results incl. tables
Summarized results:
Table 1: Summarized results for combined sex of cumulative mortality
| Acute dermal toxicity, 24h exposure, cumulative mortality | ||||
| Day | Dose (mg/ kg) | Sex | Dose (mg/ kg) | Sex |
| 0 | M/F | 2000 | M/F | |
| Cumulative mortality | Cumulative mortality | |||
| 0 | 0/4 | 0/10 | ||
| 1 | 0/4 | 0/10 | ||
| 2 | 0/4 | 0/10 | ||
| 3 | 0/4 | 0/10 | ||
| 4 | 0/4 | 0/10 | ||
| 5 | 0/4 | 0/10 | ||
| 6 | 0/4 | 0/10 | ||
| 7 | 0/4 | 0/10 | ||
| 8 | 0/4 | 0/10 | ||
| 9 | 0/4 | 0/10 | ||
| 10 | 0/4 | 0/10 | ||
| 11 | 0/4 | 0/10 | ||
| 12 | 0/4 | 0/10 | ||
| 13 | 0/4 | 0/10 | ||
| 14 | 0/4 | 0/10 | ||
Applicant's remark: 5 animals per sex have been tested. however some were tested on abraded skin. Therefore, the minimum number of tested animals is not achieved. The results show no mortality nor clinical signs whatever the sex and the abraded or intact skin. So, the deviation of the number of animals tested is considered as minor and the LD0 > 2000 mg/kg bw can be used for the classification
Table 2: Summarized results for body weight
| Acute dermal toxicity, 24h exposure | |||||
| Skin status | Dose (mg/ kg) | Sex | Mean body weight in grams | ||
| Day 0 | Day 7 | Day 14 | |||
| Intact | 0 | M | 1794 | 2050 | 2259 |
| Abraded | 0 | M | 1714 | 2049 | 2338 |
| Intact | 0 | F | 2352 | 2528 | 2756 |
| Abraded | 0 | F | 2272 | 2456 | 2662 |
| Intact | 2000 | M | 1789 | 1909 | 2163 |
| Abraded | 2000 | M | 1846 | 2046 | 2275 |
| Intact | 2000 | F | 1750 | 1946 | 2151 |
| Abraded | 2000 | F | 1808 | 2033 | 2336 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC)
- Conclusions:
- Sodium hypophosphite is not classified according to CLP (Reg. n° 1272/2008/EC).
- Executive summary:
The objective of this study was to evaluate the toxicity of Sodium hypophosphite following a single dermal application to rabbits
according to methods similar to OPPTS 870.1200 and OECD 402 guidelines. There were no information in the report about GLP compliance.
The test item was applied to the skin of one group of five males (3 with abraded and 2 with intact skin) and five females (2 with abraded and 3 with intact skin) at the dose-level of 2000 mg/kg bw. One group of 2 males and 2 females acts as a control group (1 male and 1 female with abraded skin, 1 male and 1 female with intact skin).The test site was then covered by dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy.
Neither mortality nor systemic clinical signs were observed during the study. A moderate erythema and a mild to moderate oedema were observed on removal of the dressing and cleared within 24 hours. The body weight gain of the animals was not affected by treatment compared to controls. No apparent abnormalities were observed at necropsy in any animal.
Under these experimental conditions, the dermal LD0of Sodium hypophosphite was equal or higher than 2000 mg/kg in rabbits
.
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