Tetrasodium pyrophosphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13/06/1988 to 17/06/1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FMC Non-Definitive Primary Skin Irritation Protocol (Number 10)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

see additional information on materials and methods

GLP compliance:

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
- Substance type: White solid
- Physical state: solid
- Analytical purity: On file with sponsor
- Reference No.: B606A0097
- Stability under test conditions: on file with sponsor
- Storage condition of test material: Room temperature
- Other:
FMC-T#: 637
Formulation: Technical
Date received: April 26, 1988

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on May 18, 1988
- Age at study initiation: Young
- Weight at study initiation: 2.37 - 2.50 kg
- Housing: individually housed in stainless steel cages. DAGB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): ad libitum; Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum): ad libitum; fresh tap water
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67 - 73°F
- Humidity (%): 60 - 64 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.


IN-LIFE DATES: May 18, 1988 - 17/06/1988

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: the test material was moistened with physiological saline

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gram

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 animals each with 2 test sites per animal.
2 females and 1 male.

Details on study design:

TEST SITE
- Area of exposure: 2" by 2"
- % coverage: no data
- Type of wrap if used: The test material was moistened and applied to an 8-ply, 2x2" gauze pad. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage. The animals were fitted with Elizabethan collars to prevent disturbance of the test sites.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped clean with a gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J. H.,G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: all animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

other: all animals tested

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No erythema and no edema were recorded at 4.5, 24, 48 or 72 h. Zero scores were recorded at all timepoints for all animals.

Other effects:

All animals remained healthy during the study.

Any other information on results incl. tables

Three animals, each with two test sites did not display any sign of erythema formation or edema. Zero scores were recorded at all timepoints for all six test sites.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study and in accordance with Regulation (,EC) No. 1272/2008, tetrasodium pyrophosphate is non-irritating to intact skin when applied topically to New Zealand White rabbits.

This study is considered to be scientifically justified for use as a key study.

Executive summary:

no data