Trisodium hydrogen diphosphate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium hydrogen diphosphate

EC Number:

238-735-6

EC Name:

Trisodium hydrogen diphosphate

Cas Number:

14691-80-6

Molecular formula:

H1O7P2Na3

IUPAC Name:

trisodium hydrogen (phosphonooxy)phosphonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): trisodium pyrophosphate (synonym: trisodium hydrogen diphosphate)
- Physical state: solid
- Analytical purity: >95%
- CAS # 14691-80-6
- Lot/batch No.: RS2196
- pH: 6.9 (1% solution)
- Solubility: Soluble in water
- Stability under test conditions: Test substance was expected to be stable for the duration of the test.
- Expiration date: May 10, 2015

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc on October 3, 2012
- Age at study initiation: Young adult
- Weight at study initiation:
- Housing: The animals were signly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent 'Guide for the care and use of laboratory animals'. Litter paper was placed beneath the cage and was changed at least 3 times a week.
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet # 2031. A designated amount of the diet was available to each rabbit (150 g/day)
- Water (e.g. ad libitum): Filtered tap water was available ad libitum.

There were no known contaminants reasonable expected to be found in the food or water at levels which would interfere with the results of this study. Analysis of food and water were conducted regularly.

- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 41-69%
- Air changes (per hr): 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.77 g of the test mixture.
- Concentration (if solution): 65% w/w in water

Duration of treatment / exposure:

4 hours

Observation period:

Up to 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6cm2 intact dose site
- Type of wrap if used: semi-occlusive

The test item was placed on a 1 inch by 1 inch 4-ply gauze pad. The pad and entire trunk of each animal was then wrapped with semi-occlusive 3 inch micropore tape to avoid dislocation of the pad.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was gently clensed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: All 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects noted

Results 2

Irritation parameter:

edema score

Basis:

other: all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects noted

Other effects:

All animals appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation and adverse pharmacologic effects or abnormal behaviour.

Any other information on results incl. tables

Table 1: Erythema/Edema

Animal No.	Sex	Time after patch removal
		30-60 mins	24 hrs	48 hrs	72 hrs
3501	F	0/0	0/0	0/0	0/0
3502	F	0/0	0/0	0/0	0/0
3503	F	0/0	0/0	0/0	0/0
Total		0/0	0/0	0/0	0/0
Mean		0/0	0/0	0/0	0/0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, trisodium hydrogen diphosphate is classified as non-irritating to the skin.