3-ethoxy-1,1,5-trimethylcyclohexane

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 August - 23 September 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Maximization procedure was performed on 30 healthy male and female volunteers (26 completed the study) to determine the sensitizing potential of test item.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-ethoxy-1,1,5-trimethylcyclohexane

EC Number:

266-722-5

EC Name:

3-ethoxy-1,1,5-trimethylcyclohexane

Cas Number:

67583-77-1

Molecular formula:

C11H22O

IUPAC Name:

3-ethoxy-1,1,5-trimethylcyclohexane

Test material form:

not specified

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
- Sex: 30 males and females
- 26 subjects completed the study

Clinical history:

None

Controls:

SLS controls were placed on the left and petrolatum on the right and labeled site 5.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive

METHOD
- Pre test: A patch of each test material was applied to normal sites on the backs for 48 h under occlusion. No significant evidence of irritation was observed, and all subjects were pretested with 7.5 % sodium lauryl sulfate (SLS).
- Maximization procedure: Modified after JID 47:393-409, 1966
The materials were applied under occlusion to the same sites on the volar aspects of the forearms of all subjects for 5 alternate day 48 h periods. Patch sites were pretreated for 24 h with 7.5 % aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 30 minute applications of 7.5 % aqueous SLS under occlusion without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5.

Results and discussion

Results of examinations:

After 48 and 72 h challenge exposure, SLS produced slight burns on the challenge in approximately half of the subjects as expected. No other significant allergic or irritant reactions were observed.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, test item produced no reactions that were considered significantly irritant or allergic in the 26 subjects tested.

Executive summary:

In the sensitisation study, 30 healthy male and female volunteers were screened and 26 completed the study (Maximization procedure). The test item was applied on the volar aspects of the forearms of all subjects under occlusion for 5 alternate day 48 h periods. Patch sites were pretreated for 24 h with 7.5 % aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 30 minute applications of 7.5 % aqueous SLS under occlusion without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5.

SLS produced slight burns on the challenge in approximately half of the subjects as expected. No other significant allergic or irritant reactions were observed.

Under the test conditions, test item produced no reactions that were considered significantly irritant or allergic in the 26 subjects tested.