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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A total of 10 subjects, 2 male and 8 female, were placed on the test. Patches were used occlusively. Approximately 0.2 mL test material was applied to each patch. On day one, subjects were patched with duplicate patches on each volar forearm for 24 hours. On day 2 to 4 the arms were scored.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone
EC Number:
239-360-0
EC Name:
1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone
Cas Number:
15323-35-0
Molecular formula:
C17H24O
IUPAC Name:
1-(1,1,2,3,3,6-hexamethyl-2,3-dihydro-1H-inden-5-yl)ethan-1-one
Test material form:
solid
Specific details on test material used for the study:
- Description: clear liquid

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
- Panel Selection: A total of 10 subjects, 2 male and 8 female, were placed on test. Subjects range in age from 27 to 59: 1 subject is 27 to 30; 4 subjects are 31 to 45; 5 subjects are 46 to 59. Legally valid written informed consent, in conformity with Fed. Reg. 21 CFR 50.20 - 50.25, February 9, 1981, effective July 27, 1981, pp. 7687-7689: "Reference for Elements of Informed Consent" vas secured from each subject. Each subject was assigned a permanent HRL Identification Number. Each subject completed an HRL History Form, including relevant medical history. No subject was used if he or she exhibited any dermatological or other medical or physical condition which would preclude topical application of the test material. No known pregnant nor nursing women were used on this panel. At: least six weeks elapsed since a subject was patched in a Repeated Insult Patch Test or a Photoallergy test before he or she was used in this Phototoxicity test.
- Light Source: UV-A irradiation was from four F40BL fluorescent tubes with an output at 360 nm of approximately 1.23W per 10nm of wave-length. These lamps deliver a dose of approximately 0.22 J/cm2/min at a distance of 10 cm (the distance from the lamp to the skin sites) as measured with the International Light, Inc, IL443 Phototherapy System including IL443 radiometer S/N 1108, with UV-A Phototherapy Sensor, consisting of: SEE115 Detector S/N 1125, UV-A Filter S/N 704, W Diffuser S/N 1819 for cosine spatial response and IPIR calibration.
- Patch Preparation: The Readi-Bandage (Professional Medical Products) patch was used occlusively. Approximately 0.2 mL was applied to each patch. The volar forearms were the patch sites. Patches were applied starting proximal (closest to the elbow fold) to distal (closest to the wrist) One arm was patched with the test material; because the dosage of UV-A irradiation is not erythrogenic, no "control" site is delineated on the forearm rather, the entire forearm serves as an irradiation "control" for the irradiated site to which the test material was applied. The other arm was patched with the test material, but not irradiated. (The nonirradiated arm was protected from the light source either by the subject's own long sleeve or the special HRL "mitten") The right forearm was the irradiated arm for odd-numbered subjects; the left forearm was the irradiated arm for even-numbered subjects. (Subjects were cautioned to protect the non-irradiated arm from exposure to sunlight throughout the test period.)
- Patching Schedule
-- Day One: Subjects were patched with duplicate patches on each volar forearm. The test sites were marked with gentian violet. The subjects were then instructed to keep the patches dry. Patches were worn for 24 hr.
-- Day Two: Subjects returned to HRL. The HRL Project Manager removed the patches, read the sites and recorded the scores of the patch sites of both arms. The designated forearm was irradiated and scored immediately after irradiation. (The subject's non-irradiated arm was protected from the light source either by the subject's own long sleeve or, the special HRL arm "mitten".) The test sites were re-marked with gentian violet. Subjects were reinstructed to protect both arms from ultraviolet irradiation throughout the test period.
-- Day Three: Subjects returned to HRL. The HRL Project Manager read and recorded the scores of the test sites of both arms. The gentian violet marks were renewed if necessary.
-- Day Four: Subjects returned to HRL. The HRL Project Manager read and recorded the scores of the test sites of both arms. If a 2-level or greater reaction was not observed at any site, the Phototoxicity Test was deemed complete, except that each subject was instructed to report to HRL any delayed reaction experienced.
Exposure assessment:
measured

Results and discussion

Results:
A total of 10 subjects, 2 male and 8 female, completed the test. No reactions were exhibited on the irradiated or non-irradiated sites.

Applicant's summary and conclusion