Registration Dossier
Registration Dossier
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EC number: 225-822-9 | CAS number: 5102-83-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch Test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
- EC Number:
- 225-822-9
- EC Name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
- Cas Number:
- 5102-83-0
- Molecular formula:
- C36H34Cl2N6O4
- IUPAC Name:
- 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2,4-dimethylphenyl)-3-oxobutanamide]
Constituent 1
Method
- Type of population:
- general
- Subjects:
- 200
- Controls:
- none
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Other:
Induction: eight fourty-eight-hour applications over a period of 4 weeks
Challenge: forty-eight-hour application starting 12 days after end of the last induction exposure
EXAMINATIONS
- at the end of each fourty-eight-hour exposure
- Grading/Scoring system:
0 = no reactions
1+ = slight erythema
2+ = marked erythema
3+ = marked erythema, edema, with or without a few vesicles
4+ = marked erythema, edema, with vesicles and oozing
Results and discussion
- Results of examinations:
- No visible skin changes signifying reaction to injury were observed in any of the 200 subjects at any time point.
Applicant's summary and conclusion
- Conclusions:
- The test item was not irritating to skin and did not induce a positive reaction in a Patch Test under the current test conditions. These data are in accordance with the findings of the key study (see section 7.4.1).
- Executive summary:
The test item was tested in a Human Repeated Insult Patch Test. A series of eight forty-eight-hour applications over a period of 4 weeks were performed for induction. Challenge exposure was for fourty-eight-hours twelve days after the end of the last induction exposure. No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
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