Registration Dossier
Registration Dossier
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EC number: 810-464-3 | CAS number: 13446-84-9
Skin irritation / corrosion
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:
- 2 015
- 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
- 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
- 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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