[No public or meaningful name is available]

Sensitisation data (human)

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

Test material information

Constituent 1

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:

2,4-dichloro-1-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.