Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles.

Data source

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

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Principles of method if other than guideline:
Patch test
GLP compliance:
not specified

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/batch No.: 020903/1

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 50
- Sex: 15 males and 35 females
- Age: 28-69 (males) and 18-69 (females) years
- Diagnosis:
Healthy: 9 males and 22 females
Sensitive skin: 7 females
Atopic: 6 males and 6 females
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
The test substance, diluted to 25% in paraffin oil, was applied once at 2 mg test substance/cm² to healthy skin on the back area of the test subjects using a commercial test patch. The patch was removed 48 h post-application.
Examinations:
- Skin reactions: skin reactions were evaluated immediately after patch removal (48 h post-application) and 24 h later (72 h post-application).
- Scoring system:
0: no irritation
±: slight or doubtful erythema
+: clearly recognisable erythema
++: strong erythema and/or papulation
+++: densly aggregated papules and/or vesicles
++++: blistering or necrosis

Results and discussion

Clinical signs:
No positive or doubtful skin reactions were observed at 48 and 72 h post-application in any subject. Thus, there was no indication that the test substance acts as a primary skin irritant. Furthermore, no skin reactions resulting from an existing sensitisation were induced in this test.

Applicant's summary and conclusion

Conclusions:
Not irritating. No evidence of an already existing sensitisation.