Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
other: human data
Adequacy of study:
supporting study
Study period:
2009-03-10 to 2009-03-14
Reliability:
other: not rated acc.to Klimisch
Rationale for reliability incl. deficiencies:
other: Relevant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The primary skin irritation potential of the test material was investigated during a 48 hour patch test.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- CAS name: Cyclohexanol, 4-(1,1-dimethylethyl)-, trans-
- Molecular formula: C10H20O
- Molecular weight: 156.3 g/mol
- Physical state: solid

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
HYPOTHESIS TESTED: To determine by epidermal contact the primary irritation potential of the test material

STUDY PERIOD: 2009-03-10 to 2009-03-14

STUDY POPULATION
- Selection criteria:
Inclusion criteria
a) Male and female subjects, age 16 (with parental or guardian consent) and over
b) Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c) Prohibition of use of topical or systemic steroids and /or antihistamines for at least seven days prior to study initiation.
d) Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e) Considered reliable and capable of following directions.
Exclusion criteria:
a) Ill health
b) Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c) Females who are pregnant or nursing.
d) A history of adverse reactions to cosmetics or other personal care products.

- Total number of subjects participating in study: 54 subjects were selected for this evaluation.
- Sex/age: 40 females and 14 males; ranging in age from 17 to 78
- Total number of subjects at end of study: 52 subjects completed this study. Two female subjects discontinued their participation for various reasons unrelated to the use of the test material.


Exposure assessment:
estimated
Details on exposure:
METHODOLGY.
The upper back between the scapulae served as the treatment area. Approximately 0.2 g of the test material (10% in neutral oil), or an amount sufficient to cover the contact surface was applied to the 3/4" x 3.4 " absorbent pad portion of an adhesive dressing and allowed to volatilize for several minutes. When secured to the appropriate treatment site, this dressing formed an occlusive patch.
The test material remained in contact with the skin for a total of forty eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value. The test site was reevaluated at seventy-two hours (the evaluation criteria used in this study can be see under "Any other information on materials and methods incl tables" below).
Statistical methods:
No data

Results and discussion

Results:
Observations remained negative throughout the test interval.
Confounding factors:
No data
Strengths and weaknesses:
No data

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test material SymSitive® 1609 pur (10% in neutral oil) did not indicate a potential for dermal irritation.