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Registration Dossier
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EC number: 201-923-3 | CAS number: 89-61-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Industrial Contact Dermatitis Due to Nitro and Amino Derivatives 1st Report: Mass-Examination of a Factory
- Author:
- Shiro Naniwa
- Year:
- 1 979
- Bibliographic source:
- The Journal of Dermatology Vol 6: 59-63, 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Mass-examination of all 31 employees of a chemical factory was done for the test chemical to check for its skin sensitization potential
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 1,4-dichloro-2- nitrobenzene
- IUPAC Name:
- 1,4-dichloro-2- nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): para-dichloronitrobenzene (PDCNB)
- Molecular formula (if other than submission substance): C6-H3-Cl2-N-O2
- Molecular weight (if other than submission substance): 192.001 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: employees of a chemical factory
- Age at study initiation: Males: 24-61 yrs
Females: 43-53 yrs
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0%, 0.5% and 0.1%
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 1.0%, 0.5% and 0.1%
- No. of animals per dose:
- Test Total: 31
Males: 28
Females: 3
Control: 5 humans
Males: 4
Females: 1 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hrs
- Test groups: 31
- Control group: No data available
- Site: Back of each person with adhesive plasters
- Frequency of applications: once
- Duration: 48 hrs
- Concentrations: 1.0%, 0.5% and 0.1%
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%, 0.5% and 0.1%
- Total no. in group:
- 31
- Clinical observations:
- Sensitizing
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%, 0.5% and 0.1%. Total no. in groups: 31.0. Clinical observations: Sensitizing.
Any other information on results incl. tables
other details not known
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- The test material para-dichloronitrobenzene (PDCNB) is sensitizing to the skin of human.
- Executive summary:
Mass-examination of all 31 employees of a chemical factory was performed to evaluate the sensitizing potential of the test compound para-dichloronitrobenzene (PDCNB).
The test involved applying 0.1, 0.5 and 1.0 % on the back of each person with adhesive plasters for 48 hrs. The skin reactions were read 20 min after the removal of the tested compounds according to the following criteria: 0 indicates no reaction, 1+ erythema, 2+ edematous erythema and 3+ seropapules with edematous erythema (4).
The test revealed that 9 of them were proved or suspected to have contact hypersensitivities to chemical substance used in the factory.
The test materialpara-dichloronitrobenzene (PDCNB) is sensitizing to the skin of human.
According to the publication, the test material classifies as a skin sensitizer.
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