Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
27 Feb - 21 Apr 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study-report meeting basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was performed according to a standard P&G human sensitization test protocol, dated 01 Dec 1978. Patches with test substance were applied to the upper arm of the panelists for 24 hours each, 9 times for induction and once for challenge. Scores were determined 48 hours aufter removal of the patch, shortly before applying the new patch.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl palmitate
EC Number:
205-571-1
EC Name:
Isopropyl palmitate
Cas Number:
142-91-6
Molecular formula:
C19H38O2
IUPAC Name:
isopropyl palmitate

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 112 subjects and 88 completed the study
- Sex: males and females
- Age: Not available
- Race: Predominately Caucasian
- Demographic information: Lincoln Elementary and Dayton High School
Clinical history:
- History of allergy or casuistics for study subject or populations: Yes
Controls:
No
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 6.35 cm, 5.08 or 3.81 x 17.78 cm strip of Blenderm (3M) tape to which four 2.23 cm diameter Webril (non woven cotton) discs were centrally fixed approximately 1.91 cm apart
- Vehicle / solvent: None
- Concentrations: undiluted
- Volume applied: 0.5 mL/ patch
- Testing/scoring schedule: testing was done in a period of 6 weeks, patches were applied 3 times a week), 48 hours after each of the 9 induction patches (removal 24 hours later) scoring was done, shortly before application of the new patch, challenge patch was applied at the beginning of the last week of testing and final scoring was done 48 & 96 hours after the challenge patch application.
- Removal of test substance: 24 hours after each of the 9 induction patch and 24 hours after the challenge patch.


EXAMINATIONS
- Grading/Scoring system: 0=no visible reaction, 1= mild erythema, 1E = mild erythema with papules and/or edema, 2=moderate reaction, 2E= moderate erythema with edema and/or papules, 3= strong erythema, 3E= strong erythema with marked edema, and/or papules, 4= severe reaction with erythema, edema, papules and vesicles, 5= bullous reaction, S= reaction spread beyond webril pad area.
- Statistical analysis: Not applicable

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: A total of 43/88 subjects completing the study had mild erythema (grade 1), 2/88 subjects had moderateerythema with papules/ edema (grade 2E) and one subject had mild erythema with papules/edema(grade 1E). After two weeks, treatment sites were challenged and observed at 48 & 96 hours after patch. A total of 11/88 subjects completing the study had mild erythema (grade 1)


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/88
- Number of subjects with negative reactions: 88/88
- Number of subjects with equivocal reactions:0/88
- Number of subjects with irritating reactions: 11/88 exibited mild skin irritation (grade 1) during challenge

Any other information on results incl. tables

Table 1: Irritation scores of 88 male and female adults

Total Number of Scores of:

0

1

2

3

4-5

1110

141

2

0

0

Scoring system:

0 = no irritation

1 = mild

2 = moderate

3 = strong

4 -5 = severe (usually allergy)

Applicant's summary and conclusion

Conclusions:
ISOPROPYL PALMITATE did not produce skin sensitization in humans.