1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-06-09 to 2003-07-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Clinical study according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Modified Draize procedure: Marzulli, F.N. and Maibach, H.I. (1977) Contact Allergy: Predictive Testing in Humans. In Advances in Modern Toxicology. Dermatotoxicology and Pharmacology. Eds. Marzulli, F.N. and Maibach, H.I 4, 353-372.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-370-5

EC Name:

-

Cas Number:

220410-74-2

Molecular formula:

C34H67N3O13

IUPAC Name:

tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: One hundred twenty-five subjects (36 male, 89 female) enrolled. One hundred and four subjects (32 male, 72 female) completed all phases of the study.
- Sex: male and female
- Age: 18 or older
- Race: not specified

Clinical history:

Exclusion criteria:
a. Insulin-dependent diabetes
b. Bilateral mastectomy for cancer involving removal of Iymph nodes
c. Clinically significant skin diseases which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer
d. Asthma that requires chronic medication
e. Immunological disorders such as HTV positive, AIDS and systemic lupus erythematosus
f. Treatment for any type of cancer within the last six months
g. Use of any prescribed anti-inflammatory drug, immunosuppressive drugs or antihistamine medication (steroid nose drops and/or eye drops are permitted). Any over-the-counter pain medication that is ingested in quantities exceeding label instructions
h. Topical drugs used at patch site
I. Pregnancy, lactation, or planning a pregnancy
j . Medical condition which, in the Investigator's judgement, makes the subject ineligible or places the subject at undue risk
k. Participation in any patch test for irritation or sensitization within the last four weeks or known sensitization to adhesives. Current participation in any clinical testing, including other studies being conducted at Hill Top Research, Inc.
l. Damaged skin in or around test sites which include sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles or other disfiguration of the test site

Controls:

Distilled water or 0.1% dilution (w/v) sodium lauryl sulfate in distilled water

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test, modified Draize)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: nonwoven cotton pad (Webril®) covered by and secured on all sides by hypoallergenic tape (BlendermTM)
- Vehicle / solvent: distllled water
- Concentrations: 0.1% or 0.5% (w/v)
- Volume applied: 0.2 mL
- Testing schedule:
Induction: three times per week for three weeks, each exposure approximately 24 hours
Rest period: 10 to 17-days
Challenge: 24 hours exposure to a naive site
- Removal of test substance: wipe the patch sites with water to remove any residual test material (subject instructions) .

EXAMINATIONS
- Grading/Scoring system: Inflammatory Responses: 0, +, 1, 2, 3; Superficial Effects (glazing, peeling, scab, dried film of serous exudate, hyperpigmentation, hypopigmentation, fissuring, additional comments)
- Statistical analysis: not performed

Results and discussion

Results of examinations:

Under the conditions of this study, the test article does not appear to exhibit the potential for contact sensitization at either test concentration. In addition, the test article did not appear to cause significant irritation potential during the three week induction period or during the challenge phase of the study.

Applicant's summary and conclusion

Conclusions:

Not sensitizing