Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2005
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: provides some human information, test products containing 10%-15% test article

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Approved study protocol and standard operating procedures by the New England Institutional Review Board (NEIRB) 2005
Deviations:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Test substance: a) SPF-30 sunscreen (f ormula #769-187, Homosalate content: 10%)
b) SPF-45 sunscreen (formula #769-190, Homosalate content: 15%)
c) SPF-30 sunscreen (formula #769-193, Homosalate content: 10%)
Batch: a) batch #0015C -P (white cream)
b) batch #0015C-V (white cream)
c) batch #0015C-M (white cream)

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
male and female, 236 volunteers started the study and 209 completed it
Route of administration:
dermal
Details on study design:
A repeated insult patch test (RIPT) according to the approved NEIRB study protocol was performed with 3 different sunscreens containing 10% or 15% homosalate among other substances on a panel of 236 male and female volunteers under GLP conditions.
Induction period: During the induction phase, approximately 0.2 g of the test material was applied to the dry wiped skin on the left side of the back of each volunteer. The webril/adhesive patch was semi-occlusively covered and remained on the skin for 24 hours. Thereafter, the patches were remo ved and the skin was scored. The patch removal was followed by a rest period of 24 hours for workdays or 48 hours for weekend. A series of 9 induction patches was completed over a period of 3 weeks.
Rest period: The last induction patching was followed by a rest period of two weeks with no application.
Challenge period: After the rest period, a webril/adhesive patch was applied with 0.2 g of the test material and fixed semi-occlusively on the virgin, right side of the back of each volunteer for 24 hours. After removal, the application sites were scored at about 24, 48, 72 and 96 hours post-patching. The complete test was conducted under the supervision of a Board-Certified Dermatologist, which participated also in the scorings of the volunteers.

Results and discussion

Results of examinations:
209 volunteers completed the study and 27 discontinued but not due to test material reaction. During the induction phase each one volunteers showed a transient and negligible erythema after application of sunscreen SPF-30 (a) or 45 (b) on single readings, while no skin findings were observed on the tested skin areas of any of the volunteers at any time challenge tested with these materials. With sunscreen SPF-30 (c), no skin finding was noted during induction in any of the volunteers, while one subject showed a low level reaction on the 48 hour reading but not at 24, 72 or 96 hours readings.

Applicant's summary and conclusion

Conclusions:
With none of the tested sunscreen products containing 10% or 15% test article there was an indication for an irritative or sensitizing potential under the conditions of the RIPT study in male and female Human volunteers. Thus, the substance was considered not sensitising for humans when applied at 10-15%.
Executive summary:

These reports, which presented in SCCP 1086/07, were performed in 2005 in compliance with GLP regulations according to approved study protocol and standard operating procedures by the New England Institutional Review Board (NEIRB) 2005.

209 volunteers completed the study and 27 discontinued but not due to test material reaction. During the induction phase each one volunteers showed a transient and negligible erythema after application of sunscreen SPF-30 (a) or 45 (b) on single readings, while no skin findings were observed on the tested skin areas of any of the volunteers at any time challenge tested with these materials. With sunscreen SPF-30 (c), no skin finding was noted during induction in any of the volunteers, while one subject showed a low level reaction on the 48 hour reading but not at 24, 72 or 96 hours readings. Based on these results, no potentical for dermal irritation and sensitisation to human was associated with test article (10%-15%).