Registration Dossier
Registration Dossier
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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
- EC Number:
- 404-310-0
- EC Name:
- Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
- Cas Number:
- 10591-85-2
- Molecular formula:
- C30-H28-N2-S4
- IUPAC Name:
- N,N-dibenzyl[(dibenzylcarbamothioyl)disulfanyl]carbothioamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 16 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 16 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- Approximately 70 minutes after exposure animals #1 and #2 showed slight and animal #3 diffuse conjunctival redness. Animal #1 also showed iridial injection temporary, as well as slight chemosis, which was observed in all three rabbits. The slight conjunctival redness noted had resolved in animal #2 by day 7, in animal #1 by day 14 and in animal #3 by day 16.
Treatment of the eye with fluorescein approximately 24 hours after test substance instillation showed no corneal epithelial damage in any of the rabbits. Only animal #1 showed at the first observation slight lacrimation.
Maximum scores were recorded for conjunctival redness (2) and chemosis (1) at one hour after treatment. - Other effects:
- No signs of systemic intoxication were observed in any of the rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not eye irritating
- Conclusions:
- Based on these results, TBzTD is not considered as eye irritating.
- Executive summary:
Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit acute eye irritation/corrosion test. Instillation of approximately 30 mg of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects on the conjunctivae only. Approximately 70 minutes after exposure all animals showed slight to diffuse conjunctival redness and slight chemosis and one animal showed iridial injection. The injection of the iris and the chemosis had resolved within 24 hours. The conjunctival redness resolved between days 7 and 16. Based on these results, TBzTD is not considered as eye irritating.
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