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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2-Jun-2003 to 11-Jul-2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable GLP study conducted according to a published protocol, on a related material

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Modified Draize patch test (Marzulli FN and Mailbach HI (1977). Contact allergy: predictive testing in humans. In: Advances in Modern Toxicology, Dermatotoxicology and Pharmacology, 4, 353-372, eds. Marzulli FN and Mailbach HI).
GLP compliance:
yes
Remarks:
Good Clinical Practice

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: cream

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 103 subjects completed the study (124 started - non-completion not due to adverse events related to the test material)
- Sex: male/female
- Age: 18 years or older (not more than 20% of the subjects over the age of 65 years)
- Race: no data
- Demographic information: no data
Clinical history:
Exclusion criteria:
insulin-dependent diabetes
mastectomy for cancer with removal of lymph nodes
active, clinically significant skin diseases
skin cancer
participation in patch test for irritation or sensitisation within the last 4 weeks
use of immunosuppressive drugs
regular high use of anti-inflammatory drugs, use of antihistamines or allergy injections
asthma ,requiring frequent or chronic medication
immunological disorders e.g., HIV positive, AIDS, rheumatoid arthritis and systemic lupus erythematosus
use of topical drugs on patch site
pregnancy or lactation
allergy to adhesives, bandages
any condition or medication which, in the investigator's judgement, makes the subject ineligible or at risk.
Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: no data of the patch materials used
- Vehicle / solvent: CLI 1500301 moisturizer base
- Concentrations: 0.5%
- Volume applied: 0.2 ml
- Testing/scoring schedule: patches were generally applied on Mondays, Wednesdays and Fridays and removed by the subjects about 24 or 48/72 hours later. A total of 9 patches were applied during a 4-week period to the same site on the back unless irritation reactions were cosidered to be grade 2 or above, when an adjacent site was used.
A rest period of between 10 and 21 days occurred between the last induction patch and the application of the challenge patch which was applied to a new site on the opposite back area. Patches were removed 24 or 48 hours later. During induction any skin responses were scored prior to patch re-application; after challenge reactions were scored about 48 and 72 or 96 hours after patch application.
The scoring grades are given below
- Removal of test substance: no data; presumably removed by showering/bathing

EXAMINATIONS
- Grading/Scoring system:
0 No visible reaction and/or erythema
+ Slight, confluent or patchy erythema
1 Mild reaction, macular erythema (faint pinkness)
2 Moderate reaction - macular erythema (definite redness)
3 Strong to severe reaction - macular erythema (very intense redness)

- Statistical analysis: no data

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: see Table 1 for subjects showing positive reactions during induction or challenge

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/103 after challenge
- Number of subjects with negative reactions: 103/103 after challenge
- Number of subjects with equivocal reactions: 0/103
- Number of subjects with irritating reactions: 2/103 after challenge

OTHER RESULTS:
Of the two subjects showing a positive reaction after challenge, in one (No. 79) the reaction had reduced by 96 hours and in the other subject (No. 96) it had resolved by 192 hours.

Any other information on results incl. tables

Table 1. Subjects showing erythema during induction or challenge (subjects showing only negative results are not included)

Subject

Induction day

Challenge

 

1

2

3

4

5

6

7

8

9

48 hr

96 hr

12

0

0

0

0

0

0

+

0

0

0

0

25

0

1

1

d

30

0

0

0

0

0

0

0

+

0

0

0

68

0

+

0

0

0

0

0

0

0

0

0

70

0

0

0

0

0

1

0

0

0

0

0

74

0

0

0

0

1

2

1

1

1

0

0

79

1

1

1

0

1

+

+

+

0

2

1

83

0

0

0

+

0

0

0

0

0

0

0

85

0

0

0

0

0

0

0

0

+

0

0

90

0

0

0

0

0

0

0

0

+

0

0

97

0

0

+

0

0

0

0

0

0

0

1

110

0

+

+

0

0

+

0

0

0

0

0

112

0

0

+

0

0

0

0

0

0

0

0

0 No visible reaction and/or erythema; + Slight, confluent or patchy erythema; 1 Mild reaction, macular erythema (faint pinkness); 2 Moderate reaction - macular erythema (definite redness); d Dropped out

Applicant's summary and conclusion

Conclusions:
In a reliable study conducted to GLP, Neodol 67 (C16-17 alcohols, branched) applied at 0.5% exhibited no sensitising potential in a repeated insult patch test in over 100 human volunteers.