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EC number: 200-090-3 | CAS number: 51-34-3
- 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
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Allergic contact dermatitis caused by transdermal hyoscine
- Author:
- Gordon C. R.; Shupak A.; Doweck I.; Spitzer O.
- Year:
- 1 989
- Bibliographic source:
- British Medical Journal (1989), Vol. 298, p. 1220-1221
- Report date:
- 1989
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hyoscine
- EC Number:
- 200-090-3
- EC Name:
- Hyoscine
- Cas Number:
- 51-34-3
- Molecular formula:
- C17H21NO4
- IUPAC Name:
- (1R,2R,4S,5S,7S)-9-methyl-3-oxa-9-azatricyclo[3.3.1.0^{2,4}]nonan-7-yl (2S)-3-hydroxy-2-phenylpropanoate
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 164- Sex: male
- Clinical history:
- - History of allergy or casuistics for study subject or populations: History of allergy is available for positive tested study subjects.- Symptoms, onset and progress of the disease: Pruritus and erythema at the site of the patch- Exposure history: None of the patients had previously contact with hyoscine. All subjects were treated 5 to 15 months.
- Controls:
- Placebo patches containing all the components of the patches apart from hyoscine were applied in all of the men.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test) behind the earEXAMINATIONS- Other: Clinical examination
Results and discussion
- Results of examinations:
- SYMPTOMS- Frequency, level, duration of symptoms observed: 16 patients had pruritus and erythema at the site of the patch. The pruritus started after several hours and lasted for a few days, whereas erythema was clearly evident within 24 to 48 hours after the patch was applied. Placing the patch behind the other ear produced an identical local reaction. Removal of the patch was followed by regression of the lesion. Total resolution took up to 14 days, depending on the severity of the lesion. In all cases the allergic reaction reappeared when a new patch was applied. All lesions were confined to the site of application.Clinical examinations of the lesions showed circular areas of erythema, oedema, and vesiculobullous or eczematous response in various stages of resolution. They were clearly demarcated from the surrounding skin, reproducing the circular shape, 1.5 cm in diameter, of the patch. No other local or general allergic reactions were present in any patient.NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 16RESULT OF CASE REPORT:This study showed an unexpectedly high rate (10%) of allergic contact dermatitis to transdermal hyoscine in healthy men treated for several months. Allergic contact dermatitis (type IV delayed hypersensitivity) was diagnosed by well-established clinical criteria and was further confirmed by the absence of any reaction to a placebo patch.
Applicant's summary and conclusion
- Conclusions:
- The transdermal application of hyoscine to healthy men treated for several months results in a rate of 10% of allergic contact dermatitis.
- Executive summary:
A total of 164 patients were treated for seasickness with transdermal hyoscine (scopolamine) applied as a patch to glabrous skin behind the ear. Hyoscine containing dermal patches were applied 1 – 2 times/week for several months (1.5 – 15 months). None of the patients involved had previously handled or had contact with hyoscine.
Of the 164 patients treated, allergic contact dermatitis caused by the drug was diagnosed in 16 patients. Of these patients, all had pruritus and erythema at the site of the patch. The pruritus started after several hours and lasted for a few days, whereas erythema was clearly evident within 24 to 48 hours after the patch was applied.
The study showed a high rate (10%) of allergic contract dermatitis to transdermal hyoscine in healthy men treated for several months. Allergic contact dermatitis (type IV delayed hypersensitivity) was diagnosed by well-established clinical criteria and was further confirmed by the absence of any reaction to a placebo patch.
The results were in contrast with those conducted by the manufacturer (Alza Corporation, California, USA) in which no delayed contractsensitisationoccurred in 203 subjects examined. The treatment regimen involved consecutive application of hyoscine patches daily for nine days, with a tenth application applied after a 2 week rest. The failure of such a treatment regimen does not leave sufficient time for the immune system to respond (i.e. development of activated and memory T-cells as opposed to antibody production), and consequently does not rule out the possibility of delayed type IV hypersensitivity occurring.
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