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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-09-11 ~ 2015-12-22
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 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The test was conducted before the revision.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: ElmSam:HA
Sex:
male

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 % (w/v) test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No mortality was observed relating to test substance treatment.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 % (w/v) test substance
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No mortality was observed relating to test substance treatment.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 % (w/v) test substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No mortality was observed relating to test substance treatment.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 % (w/v) test substance
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No mortality was observed relating to test substance treatment.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1 % (w/v) DNCB
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No mortality was observed relating to test substance treatment.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1 % (w/v) DNCB
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No mortality was observed relating to test substance treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This study was conducted to evaluate the skin sensitisation of SEZ-250 in guinea pigs by Buehler test. Parameters measured during study period were mortality, clinical signs, body weight changes and skin reactions.

No mortality was observed relating to test substance treatment. And all living animals in treatment group showed a normal increase of body weight.

After challenge completion with 50 %(w/v) of test substance, skin reactions were observed at 24 and 48 hours. The sensitisation index (mean score of skin reaction) and frequency index (sensitisation rate) were‘0.0’,‘0.0 %’,‘0.0’,‘0.0 %’, respectively.

In the positive control with 1 %(w/v) DNCB dissolved in corn oil, there were observed skin reaction of erythema. The sensitisation index (mean score of skin reaction) was '1.5 (24 hours)’,‘0.6 (48 hours)’and frequency index (sensitisation rate) was‘100.0 % (24 hours)’,‘60.0 % (48 hours)’, respectively.

These results indicate that this test substance is considered to have no skin sensitizing potency of SEZ-250 in guinea pigs by Buehler test under the conditions of this study.