Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
December 22, 1971
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study not conducted in accordance to accepted international guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: Repeated Insult Patch Test
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of the visible clinical responses
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 200
- Sex: 1/3 male, 2/3 female
- Age: ranged from 2 to 65 years
Controls:
No data available
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: lintine disc, 1.25 inch in diameter
- Concentrations: 4% aqueous solution
- Removal of test substance: washing with warm water

EXAMINATIONS
The contact sites were examined for visible changes after 48h period and re. examinated 24h and 48h later for delayed reactions.

Results and discussion

Results of examinations:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects during the series of applications or following the challenge application.

Any other information on results incl. tables

The composite group of four materials, as tested, was not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent, or sensitizer in any of the 200 subjects.

Insofar as sensitization is concerned, the extrapolation of these results to a general population is limited statistically by the number of test subjects.

In this case, since 200 subjects were used, we may predict with 95% certainty that at least 98. 34% of a general population will not be sensitized by this material.

Applicant's summary and conclusion

Conclusions:
Not sensitizer
Executive summary:

Direct Blue 080 has been tested for sensitisation with Repeated Insult Patch Test.No visible skin changes signifying reaction to injury were observed in any of the 200 subjects during the series of applications or following the challenge application.