Registration Dossier
Registration Dossier
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EC number: 231-987-8 | CAS number: 7783-28-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented near-guideline study but observation period was only 72 hours. A trend towards reversibility is visible.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Ammonium dihydrogenorthophosphate
- EC Number:
- 231-764-5
- EC Name:
- Ammonium dihydrogenorthophosphate
- Cas Number:
- 7722-76-1
- Molecular formula:
- H3N.H3O4P
- IUPAC Name:
- ammonium dihydrogen phosphate
- Test material form:
- other: crystalline powder
- Details on test material:
- - Name of test material (as cited in study report): Monomammoniumphosphate, Härter 26 Pulver
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL volume - Duration of treatment / exposure:
- continuous
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male and 3 female animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.05
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
Any other information on results incl. tables
|
time |
animal 1 |
animal 2 |
animal 3 |
animal 4 |
animal 5 |
animal 6 |
corneal opacity |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 d |
No data |
No data |
No data |
No data |
No data |
No data |
|
iris |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 d |
No data |
No data |
No data |
No data |
No data |
No data |
|
conjunctiva erythema |
24 h |
2 |
2 |
2 |
2 |
2 |
2 |
48 h |
1 |
1 |
1 |
1 |
0 |
1 |
|
72 h |
0 |
0 |
1 |
1 |
0 |
0 |
|
8 d |
No data |
No data |
No data |
No data |
No data |
No data |
conjunctival edema was not observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Because reversibility of the findings is expected due to the trend obvious in the individual data, the substance is considered a non-irritant.
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