2-tert-butylcyclohexyl ethyl carbonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

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 (29 completed the study) to determine the sensitizing potential of test item 82-5-29 (Ethyl t-Butyl cyclohexyl carbonate).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-tert-butylcyclohexyl ethyl carbonate

EC Number:

267-184-4

EC Name:

2-tert-butylcyclohexyl ethyl carbonate

Cas Number:

67801-64-3

Molecular formula:

C13H24O3

IUPAC Name:

2-tert-butylcyclohexyl ethyl carbonate

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): 82-5-29 (Ethyl t-Butyl cyclohexyl carbonate)

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
- Sex: 30 (men and women)
- 29 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 acceptable burns on the challenge patch in approximately half the subjects. However, in one subject the burns were sharper at all test sites than is considered desirable, indicating that 7.5 % SLS in the occasional idiosyncratic patient will be too irritating for challenge patch testing. Other than that no 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 82-5-29 (Ethyl t-Butyl cyclohexyl carbonate) produced no reactions that were considered significantly irritant or allergic in the 29 subjects tested.

Executive summary:

In the sensitisation study, 30 healthy male and female volunteers were screened and 29 completed the study (Maximization procedure). The test item, 82-5-29 (Ethyl t-Butyl cyclohexyl carbonate) 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.

After 48 and 72 h challenge exposure, SLS produced acceptable burns on the challenge patch in approximately half the subjects. However, in one subject the burns were sharper at all test sites than is considered desirable, indicating that 7.5 % SLS in the occasional idiosyncratic patient will be too irritating for challenge patch testing. Other than that no significant allergic or irritant reactions were observed.

                                          

Under the test conditions, test item 82-5-29 (Ethyl t-Butyl cyclohexyl carbonate) produced no reactions that were considered significantly irritant or allergic in the 29 subjects tested.