Isooctadecanoic acid, reaction products with tetraethylenepentamine

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Remarks:

study not completed

Adequacy of study:

supporting study

Study period:

1996-04-15 to 1996-05-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Only the pilot phase of the Human Repeat Insult Patch Test was concluded due to observations suggestive of skin sensitization in a 14-Day Cumulative Irritation Study. Supporting evidence can still be obtained from the 31 one subjects that completed induction, rest and challenge in the pilot phase.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Repeated Insult Patch Test (Modified Draize Procedure)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

EC Number:

701-204-9

Cas Number:

68784-17-8

IUPAC Name:

Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 37 enrolled; 31 completed
- Sex: 27 female, 10 male
- Age: 21-60 years of age
- Race: not specified
- Demographic information: none specified

Clinical history:

Subjects excluded from study for any of the following reasons:
-insulin dependent diabetes
-masectomy for cancer within the last year
-clinically significant skin disease
-previous participation in a patch study within last 4 weeks
-routine high dosage usage of anti-inflammatory drugs
-severe asthma
-immunological disorders
-use of topical drugs at patch site
-pregnant or lactating women
-known sensitivity to lubricant products
-daily exposure to lubricant products
-known allergy to detergents or sulfonates
-damaged skin at test site

Controls:

Mineral Oil, U.S.P. applied as vehicle control with same study schedule

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: Webril pads secured on two opposing sides with hypoallergenic tape
- Vehicle / solvent: mineral oil
- Concentrations: 100%
- Volume applied: 0.2 ml directly to semi-occluded patches and applied to skin for 24 hrs/application
- Testing/scoring schedule: Induction applications made 3 times/wk for 3 consecutive weeks; 10-17 day rest period; Challenge application on sixth week to naive site

EXAMINATIONS
- Grading/Scoring system: modified Draize

Results and discussion

Results of examinations:

There were no adverse events observed or reported during the course of the study.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, no clinical irritation or evidence of contact sensitization was observed.

Executive summary:

The objective of the study was to evaluate the potential for EC 701 -204 -9 to elicit dermal sensitization in human. This was accomplished via repetitive applications of test substance to the skin of human volunteers. Observations of irritation were reported and compared to vehicle control sites. Thirty one subjects (23 female, 8 male), between the ages of 21 and 60, completed the study. There were no adverse events observed or reported during the course of the study.