Registration Dossier
Registration Dossier
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EC number: 255-449-7 | CAS number: 41583-09-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal used
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3,5-triazine-2,4,6-triamine phosphate
- EC Number:
- 255-449-7
- EC Name:
- 1,3,5-triazine-2,4,6-triamine phosphate
- Cas Number:
- 41583-09-9
- Molecular formula:
- C3H6N6.xH3O4P
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine phosphate
- Details on test material:
- Molecular formula: C3H6N6H3O4P
Molecular weight: 224
CAS number: 41583-09-9
Description: White solid
Batch: Not indicated
Purity: >98%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Not indicated
Specific Gravity: 1.74
Stability in vehicle: At least 96 h in 1% Aq. Carboxymethyl cellulose
Constituent 1
- Specific details on test material used for the study:
- Purity >98%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Stability under test conditions: Stable
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no details reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL ( 42 mg)
- Duration of treatment / exposure:
- single exposure, no rinsing
- Observation period (in vivo):
- 14 days; values are given for 1h, 24h, 48h, 72h and 7 days.
- Number of animals or in vitro replicates:
- one
- Details on study design:
- A sample of 41.8 mg (a volume of approx. 0.1 ml) was instilled in the conjunctival sac of one eye of an albino rabbit (New Zealand White, SPF quality) after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water was instilled into both eyes to determine corneal epithelial damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Other effects:
- At the one hour reading, the scores were 1 for iris and redness of conjunctive and 2 for chemosis.
Any other information on results incl. tables
Instillation of approximately 42 mg (a volume of approx. 0.1 mL) into an eye of a rabbit resulted in effects on the iris and conjunctivae. The iridic irritation (grade 1) was noted on day 1 only. The irritation of the conjunctivae, which consisted of redness, chemosis and discharge, had completely resolved within 7 days in the animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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