Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA revision of the test for primary skin irritants, Part 191, Chapter 1, Title 21.
Deviations:
yes
Remarks:
The proposed test differs from the procedure described in the Hazardous Substances Labeling Act, Part 191.11, Chapter 1, Title 21 in that irritation is determined after a 4-h exposure period, rather than after the previously required 24-h exposure period.
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Trisodium phosphate anhydrous
- Physical state: Fine white granular powder
- Purity test date: Approximately 95 % +

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
other: Intact skin
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No data
Duration of treatment / exposure:
48 h
Observation period:
96 h
Number of animals:
Six
Details on study design:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary irritant score
Basis:
other: no data
Time point:
other: 4 h
Score:
0
Max. score:
8
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: mean 4, 24 and 48 hrs
Score:
0
Max. score:
0
Reversibility:
other: not applicable; no effects noted
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: mean 4, 24 and 48 hrs
Score:
0
Max. score:
0
Reversibility:
other: not applicable; no effects noted
Irritant / corrosive response data:
Rabbits had no edema or erythema at all observation periods.
Other effects:
No data

Any other information on results incl. tables

Table 1. Results of a skin irritation study in rabbits with trisodium phosphate.

Rabbit

No

Erythema-eschar observation

Edema observation

Sum total

Score*

4 h

24 h

48 h

4 h

24 h

48 h

1

0

0

0

0

0

0

0

 

0

 

0

0

0

0

0

0

2

0

0

0

0

0

0

0

 

0

 

0

0

0

0

0

0

3

0

0

0

0

0

0

0

 

0

 

0

0

0

0

0

0

4

0

0

0

0

0

0

0

 

0

 

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

 

0

0

0

0

0

0

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

* Sum of individual values for each rabbit divided by 6.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Trisodium phosphate was not considered to be irritating under the conditions of the study.

This study is considered to be adequate and reliable for use as a key study for this endpoint. The data in the study suggests that under test conditions trisodium phosphate is not irritating to the skin, in accordance with Regulation (EC) No. 1272/2008.