Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 23rd, 1996 - March 29th, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Federal Register Vol.46, No. 17, January 27th, 1981
Deviations:
yes
Remarks:
analytical purity of test substance not reported
Principles of method if other than guideline:
Repeated Insult Patch Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Caprylic/Capric Triglyceride
no further details

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 58 (54 completed the study)
- Sex: 7 males, 49 females
- Age: 18 - 71
- Race: no data
- Demographic information: no data
Clinical history:
Criteria for selection of subjects:
- absence of any visible skin disease
- avoidance of use of topical or systemic steroids and/or antihistamines for several days prior to study initiation
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED:
repeated insult patch test (epicutaneous test) ;

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: gauze patch
- Vehicle / solvent: none
- Concentrations: unchanged test substance
- Volume applied: 0.2 mL

INDUCTION
- application site: upper back between the scapulae
- frequency: on mondays, wednesdays and fridays for a total of ten applications
- exposure duration: 24 h

CHALLENGE
- application site: volar forearm
- frequency: once after a rest period of approximately two weeks following the tenth induction application
- exposure duration: not reported
- skin examination was performed 24 and 48 hours after challenge application

EXAMINATIONS
- Grading/Scoring system:
0 = no visible reaction
1 = mild erythema
2 = well-defined erythema, possible presence of barely perceptible edema
3 = Erythema and edema
4 = Erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed:
24 and 48 hours after challenge application a original induced site and a virgin (not induced) site (the volar forearm) was observed for skin irritation.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions on induction application: 0 (24 h exposure, reading 48 h after exposure)
- Number of subjects with positive reactions on challenge application: 0 (readings 24 and 48 h after exposure)
- Number of subjects with negative reactions: 54

Applicant's summary and conclusion

Conclusions:
The test substance was not skin sensitising in a repeated insult patch test in 54 volunteers.