Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed with 50 individuals approximately 30 years ago.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
50 volunteers were exposed to the test article in a repeated insult technique using the patch test. The test article was used as received. A series of 9 induction patches were placed on each subject. Twlelve days later a single challenge patch was made dermally.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrabromophthalic anhydride
EC Number:
211-185-4
EC Name:
Tetrabromophthalic anhydride
Cas Number:
632-79-1
Molecular formula:
C8Br4O3
IUPAC Name:
tetrabromophthalic anhydride
Details on test material:
the test article was Firemaster PHT4.

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
Male, 29-65 years of age, Caucasian, n=2.
Female, 24-62 years of age, Caucasion, n=47.
Female, 49 years of age, Negro, n=1.
Total = 50.
Controls:
Each own control.
Route of administration:
dermal

Results and discussion

Results of examinations:
A repeated insult patch test employing a panel of 50 human test subjects was conducted with FireMaster PHT4. The results showed that no irritation reactions (all scores 0) were produced in any of the subjecs during the series of induction patch applications. There was no evidence of skin sensitization in any of the subjets.

Applicant's summary and conclusion

Conclusions:
A repeated insult patch test employing a panel of 50 human test subjects was conducted with FireMaster PHT4. The results showed that no irritation reactions (all scores 0) were produced in any of the subjecs during the series of induction patch applications. There was no evidence of skin sensitization in any of the subjets.
Executive summary:

A repeated insult patch test employing a panel of 50 human test subjects was conducted with FireMaster PHT4. The results showed that no irritation reactions (all scores 0) were produced in any of the subjecs during the series of induction patch applications. There was no evidence of skin sensitization in any of the subjets.