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Sensitisation data (human)

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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:
1973
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

Constituent 1
Chemical structure
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]

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.