1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane;reaction mass of: 1-ethoxy-1,1,2,3,3,3-hexafluoro-2-(trifluoromethyl)propane

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 19 - November 04, 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted with adherence to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to SOPs and applicable protocols and monitored by QAU. Limited information about substance identity: no purity.

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:

according to guideline

Guideline:

other: to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to SOPs and applicable protocols

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

425-340-0

EC Name:

-

Cas Number:

1337538-18-7

IUPAC Name:

1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane; 1-ethoxy-1,1,2,3,3,3-hexafluoro-2-(trifluoromethyl)propane

Details on test material:

- Name of test material (as cited in study report): MTDID 3520 = 3M (TM) Cosmetic Fluid CF-76

Method

Type of population:

other: Male and female volunteers

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 210 subjects completed the study
- Sex: male and female
- Age: 16 to 79 years
- Race: No data
- Demographic information: no data available

Clinical history:

Inclusion criteria:
- Male and female subjects, age 16 and over.
- Absence of any visible skin disease which might be confused with a skin reaction from the test material.
- Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
- Completion of a Medical history form and the understanding and signing of an informed consent form.
- Considered reliable and capable of following directions.

Exclusion criteria:
- Ill health.
- Under a doctor's care or taking medication(s) which could influence the outcome of the study.
- Females who are pregnant or nursing.
- A history of adverse reactions to cosmetics or other personal care products.

Controls:

No data available.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 3/4 x 3/4 absorbent pad portion of an adhesive dressing
- Vehicle / solvent: not applicable.
- Concentrations: 100%
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase:
Patches were applied for 24 hours, three times per week (e.g. monday, wednesday and friday) for a total of nine applications. The upper back between the scapulae served as the treatment area.
With the exception of the first induction patch reading, if any test site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent site. Applications were discontinued for the remainder of this test phase, if a moderate (2-level), marked (3-level) or severe (4-level) reaction was observed on this new test site.
Challenge phase:
Approximately two weeks after the final induction path application, a challenge patch was applied for 24 hours to a virgin test site adjacent to the original induction patch site. The patch was removed and the site was scored 24 and 72 hours post-application.

EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
+ = 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
- Statistical analysis: not performed.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: 0

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 210
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:

In a human repeated insult patch test, conducted with adherence to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56, no skin reactions were observed after repeated dermal exposure under occlusive conditions when MTDID 3520 = 3M (TM) Cosmetic Fluid CF-76 is coming in contact with human skin.