Registration Dossier
Registration Dossier
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EC number: 219-514-3 | CAS number: 2451-62-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: without restrictions valid
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
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:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 219-514-3
- EC Name:
- 1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 2451-62-9
- Molecular formula:
- C12H15N3O6
- IUPAC Name:
- tris[(oxiran-2-yl)methyl]-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- 1,3,5-tris(oxiran-2-ylmethyl)-1,3,5-triazine-2,4,6-trione
- IUPAC Name:
- 1,3,5-tris(oxiran-2-ylmethyl)-1,3,5-triazine-2,4,6-trione
- Details on test material:
- TEPIC-S (lot 610806, purified) TGIC
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One Female New Zealand White rabbit, 12 - 16 weeks old, 2.9 kg bw,
5 days acclimatization period, single caging, free acces to water and diet,
room temperature: 18-20°C, relative humidity: 58%, 15 air changes/hour, 12 hour day-night cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- few minutes , then washing
- Observation period (in vivo):
- 96 hours
- Number of animals or in vitro replicates:
- one (1)
- Details on study design:
- The right eye was treated, the left eye served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animals killed for humane reasons at 4hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animals killed for humane reasons at 4hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Animals killed for humane reasons at 4hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- strong irritant to eyes
Any other information on results incl. tables
Severe ocular reactions with obvious signs of pain were seen in the single treated animal approximately 4 hours after treatment. Conjunctival reactions , identiffied by beefy redness, with haemorrhage of the capillaries of the conjunctival and nictitating membranes, severe chemosis and an extensive discharge were noted. The severity of the chemosis precluded examination of the cornea and iris at this stage.
For Humane reasons, the animal was killed and the cornea and iris were examined immediately after death. Diffuse corneal opacity and iridial inflammation were noted at this time.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US OSHA
- Conclusions:
- TGIC was highly irritant in the rabbit eye.
- Executive summary:
TGIC was highly irritant in the rabbit eye.
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