Registration Dossier
Registration Dossier
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EC number: 231-984-1 | CAS number: 7783-20-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
- Remarks:
- pre-GLP study
Test material
- Reference substance name:
- Ammonium sulphate
- EC Number:
- 231-984-1
- EC Name:
- Ammonium sulphate
- Cas Number:
- 7783-20-2
- Molecular formula:
- H3N.1/2H2O4S
- IUPAC Name:
- diammonium sulfate
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: talkum was placed into the other eye of the test animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied 50 µl bulk volume - Duration of treatment / exposure:
- instillation without rinsing
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM:
BASF scoring system, convertible to Draize score system
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
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 , 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Slight edema and conjunctival redness was noted at 1 hour after instillation of the test substance; no edema, but still slight redness was present at 24 hours. In the eyes treated with talcum, slight redness was also noted at 1 and 24 hours after exposure. No effects were noted at day 8.
Any other information on results incl. tables
Table: Draize scores
Reading |
Test substance unchanged |
Talkum (control) |
||
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
1 |
1 |
0 |
24 h |
1 |
0 |
1 |
0 |
8 d |
No findings |
No findings |
||
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