Registration Dossier
Registration Dossier
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EC number: 226-408-0 | CAS number: 5395-50-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- other: Translation
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione
- EC Number:
- 226-408-0
- EC Name:
- Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione
- Cas Number:
- 5395-50-6
- Molecular formula:
- C8H14N4O6
- IUPAC Name:
- 1,3,4,6-tetrakis(hydroxymethyl)-octahydro-[1,3]diazolo[4,5-d]imidazole-2,5-dione
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test substance number: 78/15-1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight: about 3 to 4 kg
- Housing: individually housed in stainless steel cages without bedding
- Diet: standard pellet diet for rabbits, ad libitum
- Water: ad libitum
- Acclimation period: > 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12, light from 07.00 - 19.00 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 0.1 ml
- Duration of treatment / exposure:
- single application in right or left eye
- Observation period (in vivo):
- 1 h, 24 h, 48 h, and 72 h after instillation; in the case of irritation after 72 h up to 7 d
- Number of animals or in vitro replicates:
- 6 animals in total
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Rinsing after application: no
SCORING SYSTEM: see table 1, any other information
NEGATIVE CONTROL: untreated eye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7 - 6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1 h after application, all rabbits demonstrated slight to moderate redness and slight to severe swelling of the conjuntivae in the treated eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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