Registration Dossier
Registration Dossier
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EC number: 231-509-8 | CAS number: 7601-54-9
Skin irritation / corrosion
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:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Trisodium orthophosphate
- EC Number:
- 231-509-8
- EC Name:
- Trisodium orthophosphate
- Cas Number:
- 7601-54-9
- Molecular formula:
- H3O4P.3Na
- IUPAC Name:
- trisodium phosphate
- Details on test material:
- - Name of test material: Trisodium phosphate anhydrous
- Physical state: Fine white granular powder
- Purity test date: Approximately 95 % +
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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