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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:
2015
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

Constituent 1
Chemical structure
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

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.