Registration Dossier
Registration Dossier
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EC number: 944-951-8 | CAS number: -
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October to November, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline E6 for Good Clinical Practice and 21 CFR Parts 50 and 56
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Good Clinical Practice
Test material
- Reference substance name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Cas Number:
- 190445-18-2
- Molecular formula:
- C9H19NO7
- IUPAC Name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Reference substance name:
- gluconic acid, aminopropanol salt
- Molecular formula:
- C9 H21 N1 O8
- IUPAC Name:
- gluconic acid, aminopropanol salt
- Test material form:
- liquid
- Remarks:
- 50% solution in water
- Details on test material:
- % solids in water: 48.0 - 52.0
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Identification; Samson 18
Lot#: Z333-98-497
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 213 (completed the study)
- Sex: male and female
- Age: 16 to 79 years
- Race: Not specified
- Demographic information: US (see attached report) - Clinical history:
- Criteria:
a. Absence of any visible skin disease
b. Prohibition of use of topical or systemic steroids and/or anthistamines for at least seven days prior to study initiation.
c. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
d. Considered reliable and capable of following directions.
e. Not under docter`s care or taking medication which could influence the outcome of the study.
f. Exclusion of pregnant or nursing females.
g. Exclusion of persons with a history of adverse reactions to cosmetics or other personal care products. - Controls:
- Not applucable
- Route of administration:
- dermal
- Details on study design:
- See attached report
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: all
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions; 0
Any other information on results incl. tables
See the attached report.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide, tested as Samson 18 (Lot#: Z333-98-497), indicated no potential for dermal irritation or allergic contact sensitization in human volunteers.
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