Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 27 to 30 July 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited study summary, no guideline and no GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Type of study / information:
The purpose of this study was to evaluate the potential of the test material to induce a phototoxic response in humans.
Endpoint addressed:
dermal absorption
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Phototoxicity study in humans: Volunteers were exposed to the substance via a dermal patch and observed for four days for signs of phototoxicity.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: PTDS/10-82
Purity: 1% aqueous suspension

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
The webril adhesive patch was used occlusively. Approximately 0.2 mL of the test substance was applied to each patch.
One arm was patched with the test substance. The other arm was patched with the test substance, but not irradiated.
Exposure assessment:
estimated
Details on exposure:
TYPE OF EXPOSURE: occlusively

TYPE OF EXPOSURE MEASUREMENT: Personal sampling: The HRL Project Manager read and recorded the acores of the tests sites of both arms.

EXPOSURE LEVELS:

EXPOSURE PERIOD: 24 hours

POSTEXPOSURE PERIOD: 72 hours

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:

Results and discussion

Results:
One subject exhibited a slight (+/- level) reaction on the test material site before and after irradiation.

Applicant's summary and conclusion

Conclusions:
In this Phototoxicity, the test material when administered as a 1% aqueous suspension did not induce contact dermal phototoxic reponse in human subjects.