Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: human patch testing
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To determine by epidermal contact the primary irritation potential of the test material, ColaMoist.
53 subjects, male and female age range 16 - 77 years were selected for this evaluation. 52 out of the 53 completed the study. The remaining person discontinued for personal reasons unrelated to the study.
Participants had to be over 16 and have no visible skin disease or skin complaint which might be confused with a reaction.
They were prohibited to use topical or systemic steroids and/or antihistamines for at least 7 days prior to the study initiation.
Completion of a medical history form and a consent form were required.
Exclusion criteria included; ill health, taking medication, pregnancy or nursing, a history of adverse reactions with cosmetics or personal care products.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution
Details on test material:
No batch data available. Test material assumed to be the 70% active commercially available material undiluted.

Test animals

Species:
human
Strain:
other: male and females age range 16 - 77 years

Test system

Type of coverage:
occlusive
Preparation of test site:
other: no preparation noted. Cleanliness assumed.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.2 ml of the ColaMoist 70% active solution was applied to the 3/4 x 3/4 inch absorbent pad of an adhesive dressing. (The dressings were supplied by TruMed Technologies of Burnsville, MN, USA). The patch was applied to the upper back between the scapulae of each individual.
Duration of treatment / exposure:
The test material remained in contact with the skin for a total of 48 hours.
Observation period:
The site was observed after 48 hours following removal of the patch and then re-evaluated after 72 hours
Number of animals:
52 humans

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: No subject showed any visible skin reaction from the test after 48 hours and also after 72 hours
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of the test, ColaMoist 200 at 70% active solution did not indicate a potential for dermal irritation