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Diss Factsheets
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EC number: 200-709-7 | CAS number: 69-53-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 011
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
- 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
Constituent 1
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.
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