Sodium phosphinate

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:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

Test material information

Constituent 1

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

Constituent 2

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

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

.