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Toxicological information

Sensitisation data (human)

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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

Reference
Name:
Unnamed
Type:
Constituent
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.