Registration Dossier
Registration Dossier
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EC number: 810-464-3 | CAS number: 13446-84-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-09-18 ~ 2015-12-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Cas Number:
- 13446-84-9
- Molecular formula:
- C24H28O4
- IUPAC Name:
- 2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Animal Number Cornea(Opacity) Iris Conjunctivae(Redness) Chemosis(Swelling)
1101 0.00 0.00 0.00 0.33
1102 0.00 0.00 0.00 0.33
1103 0.00 0.00 0.00 0.33
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The present study, to investigate the acute eye irritation and corrosion of S E Z-250, w as conducted with rabbits. After applica tion of test substance 0.1 m L in the eye of rabbit, param eters such m ortality, clinical signs, body w eight changes and local irritation were m easured during 72 hours observation period after application of test substa nce .
No clinical signs and m ortality were observed relating to test substance treatm ent. All tested anim als show ed norm al gains in body w eight.
After application o f test substance, eye irritation such as chem osis(sw ellin g) was observe d in all tested animals.
A ccording to the criteria for the evalua tion o f eye reactions specifie d by the Globally Harmonized System o f Classification and Labelling of Chemicals(GHS), the present observation provides only slight eye irritation. Therefore , SEZ-250 was not classified by "Hazard Class" on this study.
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