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EC number: 248-003-8 | CAS number: 26787-78-0
- 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: Case reports and Literature review.
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:
- The case reports are supplemented by a systematic literature review of antibiotic occupational asthma.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Amoxicillin
- EC Number:
- 248-003-8
- EC Name:
- Amoxicillin
- Cas Number:
- 26787-78-0
- Molecular formula:
- C16H19N3O5S
- IUPAC Name:
- 6-{[amino(4-hydroxyphenyl)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
- Results of examinations:
- RESULT OF CASE REPORT:
All patients developed a (predominantly) late asthmatic reaction accompanied by increased bronchial hyperresponsiveness as demonstrated by a fall in histamine PC20 concentration following challenge; these findings were repeatable on further testing but not seen after identical exposure to lactose powder alone. Following diagnosis, each patient avoided further exposure at work to the causative antibiotic with improvement or resolution of their symptoms. They were advised to avoid therapeutic use of amoxicillin.
Any other information on results incl. tables
Table 1. Cases of occupational asthma from antibiotics identified at Royal Brompton Hospital in the period 1995–2009.
Year of diagnosis |
Workplace exposure |
Allergic symptoms |
Latency |
Specific IgE |
Bronchial provocation test |
||
Agent |
FEV1 response |
Increase in histamine reactivity |
|||||
1996 |
amoxicillin |
wheeze, cough |
27 years |
penicilloyl G (+) penicilloyl V (+) |
amoxicillin |
late |
yes |
2000 |
amoxicillin |
wheeze, cough |
27 years |
amoxicilloyl (+) |
amoxicillin |
late |
yes |
Table 2. 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 |
1980 |
Spain |
2 |
#1: 1 years #2: 1 years
|
#1: rhinitis, dyspnoea, wheeze #2: cough, wheeze |
not reported |
negative |
Not reported |
not reported |
2 |
1997 |
Belgium |
1 |
6 months |
cough, wheeze |
not reported |
not reported |
amoxicillin: (+ER* LR*) |
not reported |
3 |
1998 |
Spain |
1 |
27 years |
cough, rhinitis,wheeze, dyspnea |
amoxicillin (-) ampicillin (-) BP* (-) BPP* (-) MDM* (-) |
amoxicillin(+) ampicillin (-) penicillin V (-) |
amoxicillin: (+ER*) penicillin V (-) |
amoxicillin (+LR*) penicillin V (-) |
*ER: early (asthmatic) response, *LR: late (asthmatic) response.
*MDM: minor determinant (penicillin) mix,*BP: benzylpenicillin
*(B)PP: (benzyl)penicilloyl polylysine
[1] E. Losada Cosmes, M. Hinojosa Macias, R. Acover Sanchez et al., “Asma por inhalaci ´on por penicilina ambiental,”Allergologia et Immunopathologia, vol. 7, supplement, pp. 288–293, 1980.
[2] O. Vandenplas, J. P. Delwiche, and M. De Jonghe, “Asthma to latex and amoxicillin,”Allergy, vol. 52, no. 11, pp. 1147–1149, 1997.
[3] I. Jimenez, E. Anton, I. Pic´ans, I. S´anchez, M. D. Qui˜nones, and J. Jerez, “Occupational asthma specific to amoxicillin,”Allergy, vol. 53, no. 1, pp. 104–105, 1998.
Applicant's summary and conclusion
- Executive summary:
Amoxicillin has been reported as a cause of work-related asthma.
Two case reports were seen and diagnosed of amoxicillin. Each of the two cases was involved in the primary manufacture or formulation of antibiotics in the United Kingdom and had presented with new onset, work-related asthmatic symptoms. All patients developed a (predominantly) late asthmatic reaction accompanied by increased bronchial hyperresponsiveness.
Previous published case reports, including a total of 4 patients, are reviewed.
Two cases of dyspnoea after inhalation of amoxicillin were described in workers in the manufacture of antibiotics; in neither case was there objective evidence of immune sensitisation to amoxicillin. A factory worker in Belgium developed occupational asthma from amoxicillin and subsequently, while employed as a nurse, to latex.
Three employees had positive skin prick tests to penicillin G and/or amoxicillin.
The patient had allergic responses to both inhaled and oral amoxicillin, but not to oral penicillin V suggesting to the authors that the responsible antigenic determinant lay in the aminohydroxyphenyl side-chain of amoxicillin.
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