Registration Dossier
Registration Dossier
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EC number: 211-185-4 | CAS number: 632-79-1
Sensitisation data (human)
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:
- 1 976
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
- Reference substance name:
- Tetrabromophthalic anhydride
- EC Number:
- 211-185-4
- EC Name:
- Tetrabromophthalic anhydride
- Cas Number:
- 632-79-1
- Molecular formula:
- C8Br4O3
- IUPAC Name:
- tetrabromo-1,3-dihydro-2-benzofuran-1,3-dione
- Details on test material:
- the test article was Firemaster PHT4.
Constituent 1
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.
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