Oligomerisation products of beta-pinene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Report of apparently well conducted human volunteer trial with detail of volunteer panel and reactions to treatment. Test material said to be directly comparable to pinene oliogomers (and reported characteristics support this). Study findings are supported by a separate (incompletely reported) human repeat-insult patch test of the same test substance in which 50 male volunteers apparently showed no skin irritation or sensitisation reactions.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

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:

Closed patch applied to skin of human volunteers for 24h: after recording of irritation, challenge by repeat patching 10-14 days later.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Foxlene Type M

IUPAC Name:

Foxlene Type M

Constituent 2

Reference substance name:

Oligomerisation products of beta-pinene

EC Number:

701-246-8

Molecular formula:

Variable (dimer = C20-H34)

IUPAC Name:

Oligomerisation products of beta-pinene

Details on test material:

- sample number 1158
- substance produced by reaction directly equivalent to that now used for manufacture of pinene oligomers and identified as terpene polymer. Reported MW corresponds to the number-average MW of pinene oligomers.

Method

Ethical approval:

not specified

Subjects:

42 adult males, 18-57 years old, 11 with declared allergies. 15 adult females, 18-57 years old, 4 with declared allergies.

Controls:

None

Route of administration:

dermal

Details on study design:

The flexor surface of one forearm was swabbed with acetone/ethyl acetate to promote localised defatting. To this area was applied a blotting paper disc (white, 1 cm diameter x 0.5 mm thick) which had been dipped into undiluted test substance. The test site was then covered with an Elastopatch adhesive strip for 24h. After removal, local reactions were observed immediately and then periodically between 10 and 14 days after first patch removal the patching procedure was repeated using the same general area of skin.

Results and discussion

Results of examinations:

No skin reactions observed after 1st and 2nd patch removal in any test subject.

Any other information on results incl. tables

No skin reactions indicative of primary irritation or contact sensitisation were observed in human volunteers.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, no evidence of human contact sensitisation was obtained.