Registration Dossier
Registration Dossier
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EC number: 229-662-0 | CAS number: 6642-31-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 6-amino-1,3-dimethyluracil
- EC Number:
- 229-662-0
- EC Name:
- 6-amino-1,3-dimethyluracil
- Cas Number:
- 6642-31-5
- Molecular formula:
- C6H9N3O2
- IUPAC Name:
- 6-amino-1,3-dimethyl-1,2,3,4-tetrahydropyrimidine-2,4-dione
- Details on test material:
- - Name of test material (as cited in study report): 1,3-Dimethyl-4-aminouracil, techn.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: mean: female: 2.89kg; male: 3.04kg
- Housing: 1 rabbit per cage
- Diet (e.g. ad libitum): about 130g per animal per day
- Water (e.g. ad libitum): about 250ml tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml bulk volume (about 57mg of the test substance)
- Duration of treatment / exposure:
- single application to the conjunctival sac of the right eyelid;
the substance was not washed out - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed out
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- cornea score: area of cornea involved: had in all animals at all timepoints score 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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