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Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Yac:NZW(KBL), Rabbit, SPF

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
animal:
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The present study, to investigate the acute dermal irritation and corrosion of SEZ-250, was conducted with rabbits. The test substance was applied to the skins of rabbits for 4 hours. Parameters such as mortality, clinical signs, body weight changes and local irritation were measured for 72 hours observation period after application of test substance.

No clinical signs and mortality were observed relating to test substance treatment. All tested animals showed normal gains in body weight.

After application of test substance, dermal corrosion and irritation were not observed in all animals. The skin irritation score was calculated "0.00" in all animals.

According to the criteria for the evaluation of dermal reactions specified by the Globally Harmonized System of Classification and Labelling of Chemicals(GHS), the present observation provides no evidence of either corrosion or irritation. Therefore, SEZ-250 was not classified by "Hazard Class" on this study.

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