Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.