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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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.