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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable with restrictions (no data on analytical purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Repeated Insult Patch Test (HRIPT)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(tridecyl) adipate
EC Number:
241-029-0
EC Name:
Bis(tridecyl) adipate
Cas Number:
16958-92-2
Molecular formula:
C32H62O4
IUPAC Name:
ditridecyl adipate

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Remarks:
(in conformity with Federal Register 21 CFR 50.20-50.25, 09 Feb 1981, effective 27 July 1982, 7687-7689)
Subjects:
- Number of subjects exposed: 104 subjects
- Sex: 19 male and 85 female subjects
- Age: 18 to 65 years old
- Race: no data
- Demographic information: no data
Clinical history:
- History of allergy or casuistics for study subject or populations: no
No subject was used if he or she exhibited any dermatological or other medical or physical condition which preclude topical application of the test material.
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive (55 subjects) / semiocclusive (49 subjects)
- Description of patch: Readi-Bandage (Professional Medical Products)
- Preparation of patch site: thoroughly cleansed with 70% isopropyl alcohol prior to patching
- Concentrations: undiluted
- Volume applied: 0.2 mL
- Testing/scoring schedule: A series of 9 induction patches were applied for a period of 3 weeks on mondays, wednesdays and fridays. Patches were removed after 24 hours, and reactions scored after a rest period of 24 or 48 hours. After the induction phase a rest period of two weeks followed. Then, the challenge patch was applied for 24 hours to a virgin site and reactions were scored after 24, 48, and 72 hours.
- Induction site: left upper back
- Challenge site: right upper back
- Removal of test substance: after 24 h

EXAMINATIONS
- Grading/Scoring system: The (modified) scoring scale of the International Contact Dermatitis Research Group System: Fisher A.A. (1973). Contact Dermatitis Lea & Febiger, Philadelphia, 29.

Results and discussion

Results of examinations:
1. SEMI-OCCLUSIVE APPLICATION:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no reactions observed during induction and challenge phase

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 39
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
- Number of subjects that discontinued study: 10

2. OCCLUSIVE APPLICATION:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no reactions observed during induction and challenge phase

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 45
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
- Number of subjects that discontinued study: 10

Applicant's summary and conclusion

Conclusions:
None of the persons that completed the study showed positive reactions under occlusive or semi-occlusive conditions.

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