Diisooctyl adipate

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:

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

Test material information

Constituent 1

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.