Ampicillin

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Literature review of case reports.

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2011

Materials and methods

Type of sensitisation studied:

respiratory

skin

Study type:

case report

Principles of method if other than guideline:

Literature review.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ampicillin

EC Number:

200-709-7

EC Name:

Ampicillin

Cas Number:

69-53-4

Molecular formula:

C16H19N3O4S

IUPAC Name:

6-{[amino(phenyl)acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid

Method

Type of population:

occupational

Route of administration:

other: inhalation, oral and dermal.

Details on study design:

TYPE OF TEST(S) USED: skin test (prick test); specific IgE; bronchial provocation test; oral challenge.

Results and discussion

Any other information on results incl. tables

Table 1. Published cases of occupational allergy to ampicillin 1953–2009

Reference	Year	Country	No.	Latency	Respiratoy symtoms	Skin test	Specific IgE	Bronchial provocation test	Oral challenge
1	1974	UK	3	#1: 2 years #2: 2 years #3: 2 years	asthma (n=3) rhinitis (n=2) eczema (n=2) conjunctivitis (n=1)	ampicillin (−)	Not reported	#1: ampicillin (+LR∗) #2: ampicillin (+LR∗) #3: ampicillin (+LR∗)	#1: ampicillin (−) #2: ampicillin (+LR∗) and intestinal symptoms
2	1980	Spain	2	#1: 1 year #2: 1 year	#1: rhinitis, dyspnoea, wheeze #2: cough, wheeze	Not reported	Negative	Not reported	Not reported
3	1982	Germany	1	NS	cough, rhinitis, dyspnea, fever	ampicillin (-)	--	--	Not reported

∗NS: not specified.

∗LR: late (asthmatic) response.

(1). R. J. Davies, D. J. Hendrick, and J. Pepys, “Asthma due to inhaled chemical agents: ampicillin, benzyl penicillin, 6 amino penicillanic acid and related substances,” Clinical Allergy, vol. 4, no. 3, pp. 227–247, 1974.

(2). E. Losada Cosmes, M. Hinojosa Macias, R. Acover Sanchez et al., “Asma por inhalación por penicilina ambiental,” Allergologia et Immunopathologia, vol. 7, supplement, pp. 288–293, 1980.

(3). B. Wuthrich and A. L. Hartmann, “Occupation-related bronchial asthma caused by ampicillin. Diagnostic significance of occupation-specific inhalation provocation tests,” schweizerischeMedizinischeWochenschrift, vol. 112, no. 29, pp. 1046–1048, 1982.

Applicant's summary and conclusion

Executive summary:

Ampicillin has been reported as a cause of work-related asthma.

Previous published case reports, including a total of 6 patients, are reviewed.

A specific provocation testing was used to confirm occupational asthma from inhaled ampicillin in three employees; in each case skin prick tests with ampicillin were negative. Oral challenge with ampicillin induced asthmatic and other allergic symptoms in two of the three cases.

The three cases reported had subtly different responses to inhaled and oral (negative in one patient) provocation tests suggesting the possibility that individually they were responsive to different hapten-protein antigens.

Two cases of dyspnoea after inhalation of ampicillin were described in workers in the manufacture of antibiotics; in neither case was there objective evidence of immune sensitisation to ampicillin.

Cumulative inhalation testing with ampicillin, caused a delayed asthmatic reaction.