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Toxicological information

Skin sensitisation

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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:
1979
Bibliographic source:
The Journal of Dermatology Vol 6: 59-63, 1979

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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 group
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.