Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Study period:
27 Jan - 07 Mar 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles. The analytical purity of the test substance is not specified.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeat Insult Patch Test (RIPT) with 113 volunteers (98 completed)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isononyl isononanoate
- Physical state: clear liquid
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 98
- Other: The odd-numbered subjects of a 200-person panel were tested with the test substance. Of 113 enrolled subjects, 98 completed. No subject discontinued due to a reaction to the test substance.
- Number of subjects exposed: 98
- Sex: 29 males, 89 females
- Age: 18-65
- Other: 113 subjects were enrolled, of which 98 completed. The subjects signed an informed consent form (conform with 21 CFR Part 50, 'Protection of Human Subjects') and completed an HRL history form, containing medical history
Clinical history:
- History of allergy or casuistics for study subject or populations: any subject exhibiting or with a history of any dermatological or other medical or physical conditions that would preclude dermal application of the test substance was excluded from the study
- Other: pregnant or breastfeeding women were not knowingly included in the study; the subjects had not been exposed in a repeated insult patch test or photoallergy test for at least 6 weeks prior to this study
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Webril/adhesive patch (Kendall Healthcare Products Company Patch #4022
- Concentrations: undiluted
- Volume applied: 0.2 mL
- Testing/scoring schedule: 9 induction exposures were performed over a period of 3 weeks; 3 inductions/week. Subjects unable to make up a missed patch the same week were patched 4 times the following week or repatched at the end of the induction phase to make 9 induction exposures. The patch remained in place for 24 h. The site was scored for skin irritation approximately 48 h after patch removal, when the subject returned for the next induction patch. The challenge was performed approximately two weeks after the last induction. The challenge patch was applied to the right scapular area and remained in place for 24 h. The sensitisation reaction at the challenge site was assessed 0, 24, 48 and 72 h after patch removal. The induction site was reassessed immediately after patch removal.
- Removal of test substance: the subject removed the patch after 24 h, so any cleaning of the site was not reported
- Other: the test site was wiped clean with a dry Kimwipe prior to each patch application. The patch was applied to the left scapular area.

EXAMINATIONS
- Grading/Scoring system:
Modified scoring scale of the International Contact Dermatitis Research Group System (Fisher, A. Contact Dermatitis, 1986; p 26).
0 = no visible reaction
± = faint, minimal erythema
1 = erythema
2 = intense erythema, induration
3 = intense erythema, induration, vesicles
4 = severe reaction with erythema, induration, (may be weeping) pustules

Results and discussion

Results of examinations:
During the induction phase, 4/98 exhibited faint, minimal erythema or erythema (score ± or 1) and 2/98 had hyperpigmentation (see Table 1). Following the challenge treatment, 11/98 exhibited faint, minimal erythema or erythema (score ± or 1) (see Table 2). These reactions are considered to be irritation reactions. The test material did not induce skin sensitisation in any of the 98 subjects.

Any other information on results incl. tables

Table 1: Induction phase, skin irritation scores

 

Induction reading

Reaction score

1

2

3

4

5

6

7

8

9

0

105

104

102

100

98

97

99

99

99

±

 

 

1

1

2

3

 

 

 

1

1

1

 

 

1

 

 

 

 

1E

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2E

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

 

No site reading*

 

 

 

 

 

 

 

 

 

^

 

 

 

 

1

 

 

 

1

Total No. subjects

106

105

103

101

101

100

99

99

99

E = edema

DR = dryness

* site reading performed at a later time point

^= hyperpigmentation

 

 

Table 2: Challenge phase, skin irritation scores

 

Challenge reading (hr after patch removal)

Reaction score

0

24

48

72

0

95

92

91

92

±

2

2

4

2

1

1

4

1

 

1E

 

 

 

 

2

 

 

 

 

2E

 

 

 

 

3

 

 

 

 

4

 

 

 

 

No site reading*

 

 

2

4

^

 

 

 

 

Total No. subjects

98

98

98

98

E = edema

DR = dryness

^= hyperpigmentation

* site reading performed at a later time point

Applicant's summary and conclusion

Conclusions:
The test substance did not cause skin sensitisation under the conditions of the study.