Registration Dossier
Registration Dossier
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EC number: 208-993-4 | CAS number: 551-16-6
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: Case report
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Reliability assessment is not appropriate for regulatory purposes.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- respiratory sensitisation
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
Test material
- Reference substance name:
- 6-aminopenicillanic acid
- EC Number:
- 208-993-4
- EC Name:
- 6-aminopenicillanic acid
- Cas Number:
- 551-16-6
- Molecular formula:
- C8H12N2O3S
- IUPAC Name:
- 6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- Details on test material:
- - Name of test material : 6-aminopenicillanic acid
Constituent 1
Method
- Type of population:
- occupational
- Subjects:
- - Number of subjects exposed: 1
- Sex: Male
- Age: 43
- Known diseases: Originally diagnosed in 1977 as a mild allergy to penicillin causing respiratory symptoms. - Ethical approval:
- not specified
- Route of exposure:
- inhalation
- Reason of exposure:
- intentional, occupational
- Exposure assessment:
- not specified
- Details on exposure:
- The patient was located in an area where the only penicillin was in the form of broths, and had no further symptoms until the development of asthma in earlier in 1995.
- Examinations:
- - Lung function parameters: bronchial challenge testing measured by forced expiratory volume in one second. The patient was tested with 6-APA and flucloxycillin.
- Medical treatment:
- The patient was investigated at the Royal Brompton Hospital
Results and discussion
- Results of examinations:
- - Lung function parameters: The forced expiratory volume in one second of the patiet was measured to assess airway resistance. A significant (60%) change sixteen hours after exposure, though symptoms had initiated seven hours after exposure. A typical delayed reaction. The patient was found not to be sensitive to flucloxycillin.
Applicant's summary and conclusion
- Conclusions:
- The patient was stated to have a definite response to 6-APA.
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