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 |
||
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
