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Registration Dossier
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EC number: 417-220-1 | CAS number: 37441-29-5 ATIPACL
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- 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:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- slight variation of humidity with a minimum at 38,9% RH
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
- EC Number:
- 417-220-1
- EC Name:
- 5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
- Cas Number:
- 37441-29-5
- Molecular formula:
- C8H2Cl2I3NO2
- IUPAC Name:
- 5-amino-2,4,6-triiodobenzene-1,3-dicarbonyl dichloride
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg per animal
- Observation period (in vivo):
- 7 day
- Number of animals or in vitro replicates:
- 6 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: enanthema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: enanthema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- other: enanthema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The lesions observed at 72h showed a total reversibility in the 6 rabbits examined on day 7.
Applicant's summary and conclusion
- Interpretation of results:
- other: slightly irritant
- Conclusions:
- From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation.
- Executive summary:
The eye irritation potential was evaluated in an experimental study according to OECD 405 guideline.
The tes item was applied into the eye of six male New Zealand White rabbits and the site was monitored for chemosis score, enanthema score, iris score and cornea opacity score. The site was monitored after application at 1h, 24h (day1), 48h, 72h and day 7.
The lesions observed at 72h showed a total reversibility in the 6 rabbits examined on day 7.
From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation.
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