1,4-dichloro-2-nitrobenzene

Endpoint summary

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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

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

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

1.0%, 0.5% and 0.1%

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%

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.

other details not known

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Skin sensitisation:

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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the publication, the test material classifies as a skin sensitizer.