Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
11 March 2008 to 15 March 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted according to generally recognized standards and with GLP compliance. Chemical characterization, including purity and stability, lacking.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Type of study / information:
Test to determine the potential of the test material to produce a photoxic response in human subjects.
Principles of method if other than guideline:
Exposure (occlusive) for 24 hours by patch test of health male and female volunteers to the test material (single application) followed at UVB and UVA irradiation of the treatment sites. Dermal scoring after 48 and 72 hours.
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Ethylhexyl methoxycrylene, Lot# ABP4-092007

Method

Ethical approval:
not specified
Details on study design:
Inclusion criteria
Health male or female volunteers:
a) 18 to 65 years of age
b) Fair skinned with skin types I - IV, as follows:
I Always burns easily; never tans (sensitive)
II Always burns easily; tans minimally (sensitive)
III Burns moderately; always tans well (normal)
IV Rarely burns; tans profusely (insensitive)
V Never burns; deeply pigmented (insensitive)
c) Dependable and capable of following directions
d) Having completed a Medical History Form
e) Having read and understood and signed an Informed Consent Form

Exclusion criteria
a) Subjects with a history of abnormal response to sunlight
b) Subjects exhibiting current sunburn, suntan or uneven skin tone; which might interfere with the study evaluation
c) Pregnant or lactating women
d) Subjects taking medication which might interfere with the test results
e) Subjects who regularly use UVA sunbeds
f) Subjects exhibiting any visible skin disease which could be considered to affect the purpose and integrity of the study
Exposure assessment:
not specified
Details on exposure:
Test method

Twenty-one (21) subjects were selected for participation.

Test site: The lower back, between the scapulae and the beltline, lateral to the midline, served as the treatment area. The area was free of sunburn, suntan, scars, active dermal lesions and uneven skin tones.

Light source: A Xenon Arc Solar Simulator (150w), producing a continuous light spectrum in the UVA and UVB regions (290-400 nm). A Schott WG 345 filter was used to block the sunburning UVB wavelengths (290-320 nm), allowing delivery of only UVA wavelengths (320-400 nm). Total dose of 20 joules.

Determination of Minimal Erythema Dose (MED): An MED is defined as the lowest time interval of dosage of UV light sufficient to produce defined erythema on designated test sites. Prior to the product test phase of the study, the MED of unprotected skin of each subject was determined by a progressive sequence of timed UV light expsoures, graduated incrementally by 25% over that of the previous exposure. The sites were evaluated for erythema according to the following scoring system:
0 = No visible reaction
0.5 = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration

Treatment phase: On the first day of the study, three (3) test sites were outlined on the back with a skin marker. Two sites were treated with the test product, one to be irriadiated and one not. The third site remained untreated but was irradiated. Approximately 0.2 mL of the test material, or an amount sufficient to cover the area, was applied to a 3/4" x 3/4" gauze portion of an adhesive dressing. This was then applied to the appropriate treatment site to form an occluded patch. Twenty-four (24) hours after treatment, the patches were removed and the appropriate sites irradiated with 0.5 MED of UVB irradiation followed by 20 joules of UVA irradiation. All test and control sites were examined at 48 (48) hours and seventy-two (72) hours following irradiation and scored as described above.

Criteria for a positive response: Based upon the interpretation of erythemal responses as follows: If the degree of erythema/tanning noted on the treatment, irradiated site is significantly greater than that observed on the non-treatment, irradiated site, the test material may be judged phototoxic.

Results and discussion

Results:
All dermal responses at all time points measured were 0.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, ethylhexyl methoxycrylene, Lot# ABP4-092007, did not induce a response indicative of a phototoxic reaction.