L-Ascorbic acid, 3-O-ethyl-

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

11 Feb - 20 Mar 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A repeated insult human patch test was conducted in 50 subjects. 0.2 mL of the test substance was applied to the skin under occlusive conditions.

GLP compliance:

no

Remarks:

according to Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

(5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one

EC Number:

617-849-3

Cas Number:

86404-04-8

Molecular formula:

C8H12O6

IUPAC Name:

(5R)-5-[(1S)-1,2-dihydroxyethyl]-4-ethoxy-3-hydroxy-2,5-dihydrofuran-2-one

Details on test material:

- Name of test material (as cited in study report): VCE-1
- Substance type: Clear colorless, liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 50
- Sex: male and female
- Age: 18 - 79 years

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: repeated insult patch test

INDUCTION EXPOSURE
- Type of application: Occlusive
- No. of exposures: 9
- Testing/scoring schedule: Subjects were treated every Monday, Wednesday and Friday.
- Description of patch: Parke-Davis Readi-Bandage occlusive patch
- Test site: The test substance was applied to the skin on the back of each subject, between the scapulae and waist, adjacent to the spinal mid-line.
- Concentrations: Not specified
- Volume applied: 0.2 mL
- Removal of test substance: The patch was removed 24 h after application.
- Evaluation (hr after induction): 48 h after patch removal (following application on Monday and Wednesday), 72 h after patch removal (following application on Friday)

CHALLENGE EXPOSURE
- Testing/scoring schedule: Subjects were challenged approximately 2 weeks after the last induction treatment.
- Test site: The test substance was applied to a previously unpatched (virgin) test site.
- Evaluation (hr after challenge): 24 and 72 h

EXAMINATIONS
- Grading/Scoring system: The dermal responses for both the induction and challenge exposure were scored according to the following 6-point scale:
0 = No evidence of any effect
+ = Barely perceptible (minimal, faint, uniform or spotty erythema)
1 = Mild (pink, uniform erythema covering most of the contact site)
2 = Moderate (pink-red erythema uniform in the entire petechiae or papules)
3 = Marked (bright red erythema with/without petechiae or papules)
4 = Severe (deep red erythema with/without vesiculation or weeping)

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No skin reaction was observed at any time during the course of the study.

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

Applicant's summary and conclusion

Conclusions:

Under the conditions of the conducted test, the test substance did not cause any skin irritation or skin sensitisation.