Registration Dossier
Registration Dossier
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EC number: 232-088-3 | CAS number: 7785-84-4
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No details on methodology included within study report.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
Test material
- 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:
- not specified
- Details on test material:
- - Name of test material : sodium trimetaphosphate
- Analytical purity: No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 10 mg - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 per treatment
- Details on study design:
- No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects noted
- Remarks on result:
- other: opacity
- Irritation parameter:
- iris score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable; no effects noted
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable; no effects noted
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no effects noted
- Irritant / corrosive response data:
- No effects were observed.
- Other effects:
- No data
Any other information on results incl. tables
Table 1 : In vivo eye irritation results in rabbits for sodium trimetaphosphate (2 animals)
Animal |
Time point (hrs) |
Cornea |
Iris |
Conjunctivae |
Score |
|||||
Opacity |
Area |
Score |
Iris |
Score |
Erythema |
Oedema |
Redness |
|||
Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Table 2 : In vivo eye irritation results (total scores) in rabbits for sodium trimetaphosphate
Dose/Response Data |
|||
Eye Structure |
Number Responding/Mean Score for 6 Rabbits |
||
24 Hours |
48 Hours |
72 Hours |
|
Cornea |
0/0 |
0/0 |
0/0 |
Iris |
0/0 |
0/0 |
0/0 |
Conjunctivae |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The paper concludes that the irritant rating of sodium trimetaphosphate in rabbits is a non-irritant.
This study is considered to support a conclusion of no classification under Regulation (EC) No. 1272/2008 (EU CLP), as part of a weight of evidence approach, as the the data clearly shows that at all time points and for relevant parameters no effects were observed.
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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