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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

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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

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.