Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

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

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

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

IUPAC Name:

73398-61-5

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.