1,2-epoxycyclohexane

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed in accordance with generally accepted scientific principles, with incomplete reporting on methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeat insult patch test performed with volunteers (male and female, 56 total). The method employed was an adaption of the repeat patch procedure by Draize. The test material was administered at concentrations of 0.6 % in Dowper, or as 0.6% in Dowanol.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,2-epoxycyclohexane

EC Number:

206-007-7

EC Name:

1,2-epoxycyclohexane

Cas Number:

286-20-4

Molecular formula:

C6H10O

IUPAC Name:

7-oxabicyclo[4.1.0]heptane

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): cyclohexene oxide

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 56
- Sex: Male and female
- Age: <21 years to > 60 years (minimum age 18)
- Demographic information: All panelists enrolled from the Erlanger Kentucky area

Controls:

Control A was Dowper and Control B was Dowanol.
All volunteers initially were treated with sample A and throughout the study to most volunteers.
Volunteers who displayed signs of irritation to sample A were treated with patches containing sample B.

Route of administration:

dermal

Details on study design:

The test concentrations are as follows; sample A1 0.6% solution of test material in Dowper, and sample B1 0.6% solution of test material in Dowanol.

Patches consisted of a square of thick cotton fabric affixed with an adhesive square, containing 0.4 ml of the test material.


Induction:
Patches containing sample A1 and B1 were applied to each volunteer's arm, and removed 24 hours post application. This occurred 3 times a week over 3 consecutive weeks.
Samples were unchanged and applied as received.

Challenge:
Volunteers were rested for 2 weeks before application of the challenge.
Duplicate challenge patches were applied to each test site, one to the original site and the other to an adjacent site.

Scoring:
The sites were scored according to the scale shown in table 2. in the field "any other information on materials and methods incl. tables".
Challenge sites were scored at 48 and 96 hours after application.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2

The two panelists displaying positive reations were considered to be sensitised to 1-tertiary-butoxy-2,3-epoxy-propane.

Any other information on results incl. tables

Table 3: Results of observations

Reading	Hours after challenge	Group	Dose level	No. with + reactions	Total no. in group
After challenge	96	test group	0.6% in Dowper	0	56
After challenge	96	test group	0.6% solution in Dowanol	0	56
After challenge	96	negative control	Dowper	0	56
After challenge	96	negative control	Dowanol	0	56

Applicant's summary and conclusion

Conclusions:

The test material is considered to be non-sensitising to the skin.

Executive summary:

 

The skin sensitisation of the test material was determined by exposing 56 human volunteers to the test material in a study according to a method similar to Draize (1959). The test material was determined to be non-sensitising as none of the 56 human volunteers displayed a positive reaction following treatment with test material. Both negative controls were valid.