Fatty acids, C10-12, esters with polylactic acid, sodium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 September - 10 October 2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, published by The Association of Food and Drug Officials of The United States, 1965 (modified)

Principles of method if other than guideline:

- Principle of test: Human repeat insult patch test (semi-occlusive)

DESCRIPTION OF TEST METHOD/CONDITIONS:
- Subjects are requested to bathe or wash as usual before arrival at the facility. 0.2 ml of the test material is dispensed onto the semi­ occlusive, hypoallergenic patch.
- The patch is then applied directly to the skin of the infrascapular regions of the back, to the right or left of the midline and the subject is dismissed with instructions not to wet or expose the test area to direct sunlight.
- After 24 h the patch is removed by the panelist at home.
- This procedure is repeated until a series of nine consecutive 24 h exposures have been made for every Monday, Wednesday, and Friday for three consecutive weeks.
- In the event of an adverse reaction, the area of erythema and edema is measured. The edema is estimated by the evaluation of the skin with respect to the contour of the unaffected normal skin. Reactions are scored just before applications two through nine and the next test date following application nine. In most instances this is approximately 24 h after patch removal. Clients are notified immediately in the case of adverse reaction and determination is made as to treatment program if necessary.
- Subjects are then given a 10 - 14 day rest period after which a challenge or retest dose is applied once to a previously unexposed test site. The retest dose is equivalent to any one of the original nine exposures. Reactions are scored 24 and 48 h after application.
- Comparison is made between the nine inductive responses and the retest dose.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

Fatty acids, C10-12, esters with polylactic acid, sodium salts

EC Number:

700-937-1

Cas Number:

1312021-45-6

Molecular formula:

not available

IUPAC Name:

Fatty acids, C10-12, esters with polylactic acid, sodium salts

Test material form:

liquid: viscous

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects enrolled: 52
- Number of subjects completing study: 50
- Sex: 11 males, 41 females
- Age: 19 - 65
- Race: 45 caucasion, 7 hispanic

Clinical history:

Standards for Exclusion from a Study:
- Individuals under 18 years of age.
- Individuals who are currently under a doctor's care.
- Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
- Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
- Individuals diagnosed with chronic skin allergies.
- Female volunteers who indicate that they are pregnant or lactating.

Standards for Inclusion in a Study:
- Individuals who are not currently under a doctor's care.
- Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
- Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
- Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
- Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing.
- Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.

Recruitment:
Panel selection is accomplished by advertisements in local periodicals, community bulletin boards, phone solicitation, electronic media or any combination thereof.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: Parke-Davis Hypoallergenic Readi Bandages or the equivalent, trimmed at right angles on opposite sides to the opening of the paper backing of patch, allowing air flow.
- Vehicle / solvent: glycerol
- Concentration: 25%
- Volume applied: 0.2 mL
- Testing/scoring schedule: 24 h after application, the patch is removed by the panelist at home. This procedure is repeated until a series of nine consecutive 24 h exposures have been made for every Monday, Wednesday, and Friday for three consecutive weeks.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No adverse reactions of any kind were noted during the course of this study.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

RESULT OF CASE REPORT:
The test material when tested under semi-occlusion may be considered a non-primary irritant and non-primary sensitiser to the skin

Applicant's summary and conclusion

Conclusions:

Interpretation of results: not irritating and not sensitising to skin

Executive summary:

The test material diluted in glycerol to obtain a 25% (w/w) solution when tested under semi-occlusion may be considered as a non-primary irritant and non-primary sensitiser to the skin.