Tetrasodium pyrophosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-11-1979 to 4-12-1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA proposed guidelines for registering pesticides in the U.S; Fed. Reg. 43:163, 37336-37402

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium pyrophosphate

EC Number:

231-767-1

EC Name:

Tetrasodium pyrophosphate

Cas Number:

7722-88-5

Molecular formula:

H4O7P2.4Na

IUPAC Name:

tetrasodium (phosphonatooxy)phosphonate

Details on test material:

- Name of test material (as cited in study report): tetrasodium pyrophosphate granular
- Physical state: solid
- Analytical purity: 97.0%
- Lot/batch No.: 295-9-13

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, CA
- Housing: 2 animals per cage , in suspended steel cages (24" x 16.5" x 14")
- Fasting period before study: overnight
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-70°F

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: non-absorbant binder, held in place with gauze.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the 24 hour exposure period, wrappings were removed and the skin wiped (not washed) to remove any remaining test substance.
- Time after start of exposure: 24 hrs

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

other: sham treated

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight; animals were weighed on days 0, 7, 14 0r at death.

Statistics:

LD50 values were calcualted according to the Litchfield-Wilcoxon method.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during treatment or observation periods.

Clinical signs:

other: Local effects: mild erythema and dedema. Sins of toxcity: all animals appeared normal throughout.

Gross pathology:

No gross abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of tetrasodium pyrophosphate was determined to be >2000 mg/kg bw. In accordance with Regulation (EC) No. 1272/2008 (EU CLP) tetrasodium pyrophosphate is not considered to be acutely toxic via the dermal route.

Study is conducted to an appropriate guideline, raw data is provided and therefore the study is considered to be acceptable for assessment and use as a key study.