Registration Dossier

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: case report
Adequacy of study:
supporting study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Case report

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1985
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Study type:
other: Case report
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
no guideline required
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
EC Number:
239-898-6
EC Name:
4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
Cas Number:
15793-73-4
Molecular formula:
C34H28Cl2N8O2
IUPAC Name:
4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[5-methyl-2-(4-methylphenyl)-2,4-dihydro-3H-pyrazol-3-one]

Method

Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age: 49
- Demographic information: cleaning personal
- Known diseases: sensitisation to rubber
Route of exposure:
dermal
Reason of exposure:
intentional, occupational
Exposure assessment:
not specified

Results and discussion

Clinical signs:
symptoms: sharply defined glove dermatitis after wearing of PVC gloves



Any other information on results incl. tables

Pigment tested at 2% and 0.5% in petrolatum, result: 2+ reaction (both concentrations)

Patch test with glove: weak reaction

Other ingredients: negative

10 control tests with pigment (2% in petrolatum): negative

Applicant's summary and conclusion

Executive summary:

One case report documents the sensitisation to Irgalite Orange F2G (Pigment Orange 34) after the use of PVC gloves.

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