2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976-11-30 to 1977-01-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles with deviations: non-GLP study, no data about purity and no certificate of analysis of test substance; no information on the testing laboratory; individual irritation scores not reported

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Method: Draize Repeated Insult Patch test

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

EC Number:

237-551-3

EC Name:

2-ethynyltetrahydro-2,6,6-trimethyl-2H-pyran

Cas Number:

13837-60-0

Molecular formula:

C10H16O

IUPAC Name:

2-ethynyl-2,6,6-trimethyloxane

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2.0% Lyp or LYPTOL

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 60
- Number of subjects completed the study: 54
- Sex: 12 males; 42 females
- Age: 19-63 years
- Race: No data
- Demographic information: No data

Clinical history:

- History of allergy or casuistics for study subject or populations: No person was accepted with active dermatologic conditions or other discernible illnesses.
- Medical history (for skin hypersensitivity): Previous sensitivities or history of allergy were noted but not considered to be reasons for rejection of volunteers.

Controls:

No

Route of administration:

dermal

Details on study design:

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

PREPARATION OF THE SITE OF APPLICATION: Prior to the application, the application sites were cleansed vigorously with an ether-acetone mixture to remove any sebum or foreign material such as powders or bath oils while simultaneously mechanically removing layers of the protective keratotic outer-skin.

TESTING/SCORING SCHEDULE:
PILOT STUDY:
- Test material was applied under closed patches to the inner surface of the left deltoid area on a pilot group of ten subjects.
- When after 24 h of exposure there were no complaints of itching, burning or other paraesthesia, the patch tests were allowed to remain in situ for an additional 24 h, after which they were removed and the application sites were observed for dermal reactions.

MAIN STUDY:
A. INDUCTION EXPOSURE:
- Type of application: Occlusive
- No. of exposures: Ten
- Description of patch: Test material solution was applied to individual absorbent patches and then these patches were applied to the area of application. The patches were secured by means of overlying strips of impervious adhesive tape which were then further occluded with additional overlying strips of similar tape.
- Vehicle / solvent: Dimethyl phthalate
- Concentration: 2 %
- Volume applied: 0.5 cm3 (equivalent to 0.5 mL)
- Site: Applied alternatively on the inner surfaces of the right deltoid and the left deltoid areas
- Exposure period: 24 h for the first application and 48 or 72 h for the remaining applications (72 h on the weekends only)

B. CHALLENGE EXPOSURE:
- No. of exposures: Once in duplicate
- Day of challenge: Two weeks after the last application of the induction exposure
- Exposure period: 48 h
- Site: Applied on the inner surfaces of the right deltoid and the left deltoid areas
- Evaluation (h after removal of challenge patch): 0 h, 24 h and 5 days

Results and discussion

Results of examinations:

- No allergic reactions were noted.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test item, 2.0 % Lyp produced a 0% (0/54) sensitisation rate and was considered to be a nonsensitiser to human skin.

Executive summary:

In a Draize Repeated Insult Patch Test, 60 human volunteers were topically induced with 0.5 mL of the test item, 2.0 % Lyp in dimethyl phthalate via occluded patches. The application was repeated ten times and the patches were applied alternatively on the inner surfaces of the right deltoid and the left deltoid areas. Exposure period was 24 h for the first application and 48 or 72 h for the remaining applications (72 h on the weekends only). After 2 weeks of rest period, duplicate challenge patches of the test material was applied to the right deltoid and the left deltoid areas for 48 h. Sensitisation reactions were recorded at 0 h, 24 h and 5 days after removal of the challenge patches.

Of the 60 volunteers, 54 completed the study. The test item produced no reaction in any of the volunteer.

Under the test conditions, the test item, 2.0 % Lyp produced a 0% (0/54) sensitisation rate and was considered to be a nonsensitiser to human skin.