Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A mixture of various paint compounds was tested for its sensitization potential, using patch tests on human skin. However, this mixture was not equivalent to the submission substance identity, as no information on the percentage of the individual substances within the tested mixture was available. Therefore, the study is insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The method employed in carrying out this test was similar to that described in "Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics by J.H. Draize and published by the Association of Food and Drug Officials of the United States.

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Mixed Imron(r) Green Paint-New
The components of the tested mixtures were:
- Titanium dioxide, CAS No. 13463-67-7
- Carbon Black, CAS No. 1333-86-4
- Monastral blue, CAS No. 147-14-8
- Chrome yellow, CAS No. 1344-37-2
- Phthalocyanine green, CAS No. 1328-53-6
- Acrylic resin, no CAS No.
- Cellosolve acetate, CAS No. 111-15-9
- VM&P naphtha, no CAS No.
- Dibutyltin dilaurate, CAS No. 77-58-7
- Silicone S-61023, no CAS No.
- Polyisocyanate, CAS No. 28182-81-2
- Aromatic hydrocarbon, CAS No. 64742-95-6
- Butyl Acetate, CAS No. 123-86-4
- Ethyl Acetate, CAS No. 141-78-6
No information on the percentage of the individual substances within the tested mixture was available.

Method

Type of population:
general
Ethical approval:
other: Each subject was required to read, understand and sign an informed consent statement.
Subjects:
- Number of subjects exposed: 104
- Sex: 32 males, 72 females
- Age: from 17 to 68 years of age
- Race: Caucasian
Route of administration:
dermal
Details on study design:
The test involved the application of the test article to the upper arms of a group of 104 (32 male and 72 female) volunteer caucasian subjects. These subjects were all determined to be in generally good health, free of any visible skin disease or anormaly in the area to be patched.
For induction, ca. 0.2 ml of the test substance was applied onto the upper arm for 24 hours. The test substance was removed, acetone was used to clean the test site and the skin was examined for any dermal response. After a rest for a 24 hours period, a second application was conducted under the same test conditions as before. This procedure was repeated on alternate days until a series of 10 applications was made.
The challenge application was conducted after a rest of 2-3 weeks in the same manner and to the same sites as described above. A duplicate challenge application was also applied in the same manner to a virgin site (previously untreated) on the other arm. The challenge reaction was removed after 24 h and the sites were examined for signs of sensitization. Follow-up examinations were conducted at 48 h after challenge application.

Results and discussion

Results of examinations:
No skin irritation effects were observed in all individuals tested during the whole induction period. One individuum showed a positive reaction (erythema with induration) 24 h as well as 48 h after challenge on the original site as well as on the virgin site. One individuum showed a positive reaction and 48 h after challenge on the original site (well defined erythema) as well as on the virgin site (erythema with induration). One individuum showed a positive reaction (erythema with induration) 48 h after challenge on the original site. The remaining individuals did not show any reaction 24 h or 48 h after challenge at any site.

Applicant's summary and conclusion