Trisodium trimetaphosphate

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

not applicable

Principles of method if other than guideline:

The finely ground powder and a 20.0% aqueous solution were applied to the clipped, intact skin of albino rabbits and removed after twenty-four hours with soap and warm water. The application was covered with plastic strips. Observations were made over a period of several days for irritation.

GLP compliance:

no

Remarks:

study predates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium trimetaphosphate

EC Number:

232-088-3

EC Name:

Trisodium trimetaphosphate

Cas Number:

7785-84-4

Molecular formula:

H3O9P3.3Na or O3P3.3Na

IUPAC Name:

Sodium trimetaphosphate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Sodium trimetaphosphate
- Substance type: finely ground powder
- Physical state: solid
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

The animals were albinos.
There is no further data on animals or conditions.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: the test material was applied as an aqueous solution and neat.

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
The test material was applied neat, the amount was not stipulated.
The test material was also applied as a 20.0% aqueous solution.

VEHICLE
- water

Duration of treatment / exposure:

24 hours

Observation period:

several days

Number of animals:

Six animals were used in Total.
Three animals were applicated with the neat form of the test material and three animals were applicated with the 20.0% aqueous solution.

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: plastic strips covered the test site.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test material was removed with warm water and soap.
- Time after start of exposure: 24 hours

SCORING SYSTEM: The data, scored according to the method of Draize, Woodard and Calvery (J. of Pharm. and Exp. Therapeutics, Volume 82, December, 1944).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: This result is for the application of the substance in powder form

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: this result is for the application of the substance in powder form

Irritant / corrosive response data:

Applied in powder form: No redness or swelling was noted during or after a 24 h exposure.

Applied as 20.0% aqueous solution: No change in colour was noted after 1, and 4 hours. By 24 h there was barely perceptible erythema with no edema for an average score of 1.0 out of a possible 8. The erythema disappeared in all subjects within 24 h following removal of the application.

Other effects:

no data

Any other information on results incl. tables

Table 1 - Skin irritation in rabbits - sample applied as a finely ground powder

Animal #	Numerical evaluation at the end of
	1 h	4 h	24 h	48 h	72 h
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
Avg.	0.0	0.0	0.0	0.0	0.0

A score of 0 is sufficient to classify the test material as non-irritating in powder form.

Table 2 - Skin irritation in rabbits - sample applied as a 20.0% aqueous solution

Animal #	Numerical evaluation
	1 h	4 h	24 h	48 h	72 h
1	0	0	1	0	0
2	0	0	1	0	0
3	0	0	1	0	0
Avg.	0.0	0.0	1.0	0.0	0.0

A score of 1(/8) is sufficient to classify the test material as a slight irritant in liquid form.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the author's system of classification the test material, in liquid form, was considered to be a slight skin irritant based on the results observed at 24 hours. In powder form the test material produced no perceptible effects and was therefore classed as non-irritating.

his study has been selected as the key study in accordance with Regulation (EC) No. 1907/2006 (REACH) because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The conclusion on classification and labelling is supported by the data provided in the supporting study.