Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Clinical test conducted according to standard method and to GCP. However, the panel size was lower than recommended and there was no information on the purity of the test material

Data source

Reference
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:
no guideline followed
Principles of method if other than guideline:
In vivo patch test of standard clinical methodology
GLP compliance:
yes
Remarks:
According to GCP

Test material

Constituent 1
Chemical structure
Reference substance name:
Decane-1,2-diol
EC Number:
214-288-2
EC Name:
Decane-1,2-diol
Cas Number:
1119-86-4
Molecular formula:
C10H22O2
IUPAC Name:
decane-1,2-diol

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 55
- Sex: Male and female
- Age: 16 - 78 years
- Race: Not reported
- Demographic information: Not reported
Clinical history:
Inclusion criteria:
1. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
2. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
3. Completion of a Medical History form and the understanding and signing of an Informed Consent form
4. Considered reliable and capable of following directions.
Exclusion criteria:
1. Ill health.
2. Under doctor'scare or taking medication(s) which could influence the outcome of the study.
3. Females who were pregannt or nursing.
4. A history of adverse reactions to cosmetics or other personal care products.
Controls:
There were no contemporary controls
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests:

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: Semiocclusive patch
- Description of patch: 1" x 1" absorbent pad with a clear adhesive dressing manufactured by TruMed Technologies, Inc., Burnsville, MN, USA
- Vehicle / solvent: Not reported
- Concentrations: 0.2 g of test material
- Volume applied: Not reported
- Testing/scoring schedule: Induction patches were applied in the same location three times per week for a total of nine applications and the skin area was assessed at the removal ofeach patch. The challenge patch was applied two weeks after the final induction patch and was applied to a virgin test site.
- Removal of test substance: Not reported
- Other: Applications were discontinued if a moderate (level 2) reaction was observed on the new test site or if marked (level 3) or severe (level 4) reactivity was noted.

EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction; + = Barely perceptible or spotty eryhthema; 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.
- Statistical analysis: Not conducted

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms were reported for any of the individuals

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: None
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: None
- Number of subjects with irritating reactions: None

RESULT OF CASE REPORT: All observations remained within normal limits throughout the test interval

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test material Ref# AM1-0049 did not indicate a potential for dermal irritation or allergic contact sensitisation.
Executive summary:

Observations of the skin beneath the applied patches at 24 and 72 hours post application of the challenge patch revealed observations which were considered to be within normal limits throughout the test interval. Under the conditions of this study, Decan-1,2-diol (AM1 -0049) did not indicate a potential for dermal irritation or allergic contact sensitisation.