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Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP or guideline study defined

Data source

Reference
Reference Type:
publication
Title:
Dinitrochlorobenzene sensitization in children with bronchial asthma
Author:
Elaraby I.I.
Year:
1979
Bibliographic source:
Annals of Allergy, 43, 190-192, 1979

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
other: study in patients
Principles of method if other than guideline:
other: see executive summary
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dichloro-4-nitrobenzene
EC Number:
210-248-3
EC Name:
1,3-dichloro-4-nitrobenzene
Cas Number:
611-06-3
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
1,3-dichloro-4-nitrobenzene
Details on test material:
no data

Method

Type of population:
general
Controls:
no data
Route of administration:
other: not mentioned

Results and discussion

Any other information on results incl. tables

Asthmatic Patients: Case Description and Results of Investigations

 Case No:  Sex  Age in years  Age at onset  No.of attacks per year  Severity  Eosinophillic count/cmm  Result of DNCB test Result of PPD test  Remarks 
 1  M  2 -6/12  40 days  12  Mild  ND  positive(2 +)  ND  
 2  M  1  5 months  12  Mild  71  negative  negative  *
 3  F  3  7 months  36  Mild  ND  positive (4 +)  ND  
 4  M  4  3 -10/12 years  24  Severe  396  negative  negative  *
 5  M  2 -2/12  1 year  24  Severe  210  positive (2 +)  ND  
 6  F  2 -6/12  1 year  24  Moderate  ND  negative  ND  
 7  F  1 -9/12  1 -7/12 years  24  Severe  2080  negative  negative  *
 8  M  6  5 years  24  Moderate 570 negative   ND  
 9  F  6  3 years  24 -36  Moderate  ND  positive (2 +)  ND  
 10  F  3 -3/12  2 -6/12  24  Severe  320  positive (4 +)  ND  
 11  M  8  3 years  12  Moderate  740  positive (4 +)  ND  
 12  F  5  3 years  2  Mild  ND  negative  ND  

 13

  F  4  3 months  24 -36  Moderate  ND  positive (4 +)  ND  
 14  F  1  7 months  12  Moderate  ND  positive (1 +)  ND  
 15  M  4  1 year  24  Severe  740  negative  negative  *
 16  F  4  2 months  24 -36  Moderate  1200  positive (2 +)  ND  
 17  F  5 -6/12  2 months  2 -4 Mild   1395  negative  ND  
 18  M  1 -6/12  1 -2/12 years  24  Severe  ND  positive (1 +)  ND  
 19  M  4  3 years  12  Moderate  ND  negative  ND  
 20  F  11  2 years  36 -40  Moderate  ND negative   negative  *
 21  F  12  1 year  10  Moderate  65  negative  ND  

1. Patients who had spontaneous flare at all three sites two weeks after application were considered as 4 +.

2. Patients who had spontaneous flare at the higher dose only were considered 3 +.

3. Patients who showed no spontaneous flare but showed reaction to the two challenging doses were considered 2 +.

4. Patients who showed no spontaneous flare, and showed a reaction to the intermediate concentration of the challenging doses only and no reaction to the lower dose, were considered as 1 +.

5. Patients who neither reacted spontaneously nor to any of the challenging sites were considered as negative.

*: Previously vaccinated with BCG

M: male

F: female

ND: Not done

Applicant's summary and conclusion

Executive summary:

Twenty-one patients with bronchial asthma were studied. Nine were males and twelve were females. Their ages ranged from one to 13 years with a mean of four years and four months. All patients were sensitized and tested by the test substance. Scoring was done according to the following criteria:

1. Patients who had spontaneous flare at all three sites two weeks after application were considered as 4 +.

2. Patients who had spontaneous flare at the higher dose only were considered 3 +.

3. Patients who showed no spontaneous flare but showed reaction to the two challenging doses were considered 2 +.

4. Patients who showed no spontaneous flare, and showed a reaction to the intermediate concentration of the challenging doses only and no reaction to the lower dose, were considered as 1 +.

5. Patients who neither reacted spontaneously nor to any of the challenging sites were considered as negative.

PPD intradermal test was performed on the five patients who had been previously immunized with BCG. The reaction was considered negative if the redness and indurations were less than 6 mm in diameter after 48 hours.

The response to the test substance sensitization of the asthmatic children was as follows: four patients were 4 +, four patients were 2 +, two patients were 1+ and eleven patients were negative. This indicates that delayed hypersensitivity to the test substance could not be developed in 52.3% of asthmatics. All the five patients who were tuberculin tested were negative. Interestingly they were negative to the test substance as well.