Registration Dossier
Registration Dossier
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EC number: 222-908-8 | CAS number: 3658-77-3
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2016
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human repeated insult patch test performed according to Harrison Research Laboratories Inc. Standard Protocol #100 and SOPs
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-hydroxy-2,5-dimethylfuran-2(3H)-one
- EC Number:
- 222-908-8
- EC Name:
- 4-hydroxy-2,5-dimethylfuran-2(3H)-one
- Cas Number:
- 3658-77-3
- Molecular formula:
- C6H8O3
- IUPAC Name:
- 4-hydroxy-2,5-dimethylfuran-3(2H)-one
- Test material form:
- solid
- Remarks:
- powder
- Details on test material:
- - Description: White to pale yellow powder
- Storage condition of test material : Dry area, unopened containers, optimum temp. 11-25°C / 52-77°F
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Remarks:
- Legally valid written IRB-approved Informed Consent, in conformity with 21CFR50.25, Subtitle 1
- Subjects:
- - Number of subjects exposed: 108 subjects completed the test
- Sex: 27 males; 81 females
- Age: 18-70 years
- Race: not reported
- Demographic information: not reported - Clinical history:
- Subjects had no pre-existing conditions that would interfere with results as determined by medical history.
- Controls:
- ethanol/diethyl phthalate (1:3) (HRIPT-5025-2B)
saline (HRIPT-5025-3B) - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Description of patch: webril/adhesive patch (25 mm Hill Top Chamber System)
- Vehicle / solvent: ethanol/diethyl phthalate (1:3)
- Concentrations: 0.5% in ethanol/diethyl phthalate (1:3)
- Volume applied: Approximately 0.3 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications (24h) over a period of approximately three weeks
Phase III (challenge phase): 2 weeks after the last induction (rest period), on a new skin site, for 24-hr
- Removal of test substance: Not reported
EXAMINATIONS
Grading/Scoring system: Modified scoring scale of the International Contact Dermatitis Research Group System (Fisher, Alexander A., Contact dermatitis, Lea&Febiger, Philadelphia, 2008:p27)
0 = No visible reaction
± = Faint, minimal erythema
1 = Erythema
2 = Intense erythema
3 = Intense erythema, induration, vesicles
4 = Severe reaction with erythema, induration, vesicles, pustules (may be weeping)
E = Edema
DR = Dryness
P = Peeling
S = Staining
^ = Hyperpigmentation / Hypopigmentation
TR = Tape reaction
C = Change of test site
N9R = No 9th reading
- = No reading
X = Discontinued
- Statistical analysis: None
Results and discussion
- Results of examinations:
- SYMPTOMS
- Faint, minimal erythema observed in one male, during scoring 5 to 9 of induction phase
- Faint minimal erythema observed in one male during scoring 1 of the challenge phase.
- Faint minimal erythema and dryness observed in one male during scoring 3 and 4 of the challenge phase.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 108
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 3
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study, the test material is not a skin sensitizer at 0.5% in ethanol/diethyl phthalate (1:3).
- Executive summary:
A panel of 108 male and female human volunteers participated in a repeat insult patch test in which the test material at 0.5% in ethanol/diethyl phthalate (1:3) was applied under occlusive patches. During the induction phase nine patches were applied. Two weeks after the last induction application, a challenge patch was applied and the sites scored 24 h (after removal of patch).
Under the conditions employed in this study, there was no evidence of sensitisation to the test material.
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