Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
16 Sep - 25 Oct 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles.

Data source

Reference
Reference Type:
other: report on study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The study was conducted under GCP conditions according to the method of Marzulli and Maibach.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- LOT: 02070265

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 55, however only 51 subjects were available at study termination.
- Sex: 13 male, 42 female
- Age: 18-70 years
Clinical history:
None of the subjects had a history of acute or chronic dermatologic medical or physical conditions that could interfere with dermal scoring.
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: other immunological tests: Marzulli and Maibach Method

ADMINISTRATION
- Type of application: For induction, occlusive exposure for 48 hours, three times a week for three weeks on the back was performed. After a two week recovery period, a challenge exposure was performed under an occlusive dressing for 48 h either on the same site as the induction or another site that had never had contact with the test substance. The test sites were re-evaluated at 72 and 96 hours.
- Description of patch: occlusive strip with Flexcon (TruMed Technologies Inc., Burnsville, Minnesota)
- Vehicle / solvent: no
- Concentrations: undiluted test substance


EXAMINATIONS
- Grading/Scoring system: see Table 1

- Other: After each induction exposure, cutaneous reactions were evaluated directly as well as 24 and 48 h after patch removal.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: No significant reaction attributable to sensitisation was observed in the 51 volunteers finishing the study.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 51 (not all subjects finished study up to challenge)
- Number of subjects with irritating reactions: 1/53 (not all subjects continued study up to induction)


Any other information on results incl. tables

Table 2: Subjects with positive reactions at the study stages

Study stage

Subjects with positive reactions/all subjects*

Induction day 1

1/53**

Induction day 2

1/53**

Induction day 3

0/52

Induction day 4

0/51

Induction day 5

0/51

Induction day 6

0/51

Induction day 7

0/51

Induction day 8

0/51

Induction day 9

1/50***

48h after challenge

0/51

72h after challenge

0/50

96h after challenge

0/48

* The number of subjects changed during the study because of subjects that didn't continue the study or subjects that were not present at single observation days.

**One subject showed minimal or doubtful response, slightly different from surrounding normal skin

*** None of the subjects showed any sensitisation to the test material and only one showed slight irritation (+) at Day 9 of induction. The test material when applied to the human skin is not irritating and not sensitising.

Applicant's summary and conclusion

Conclusions:
In a study with human volunteers the test substance did not show a skin sensitisation potential.