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Diss Factsheets
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EC number: 947-802-5 | CAS number: -
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Non guideline study but sufficiently documented reliable methodology
Data source
Reference
- Reference Type:
- publication
- Title:
- First epidemiological study of contact dermatitis in Spain-1977. Spanish Contact Dermatitis Research Group
- Author:
- CAMARASA, J.M
- Year:
- 1 979
- Bibliographic source:
- Acta Derm. Venereol. [Suppl.] (Stockh.) 59(85), 33-7
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated Insult Patch Tests (HRIPT) Patch-tested according to Standard International Contact Dermatitis Research Group (ICDRG) Procedure
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- No new test performed as clinical data are already available
Test material
- Reference substance name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Cas Number:
- 8001-54-5
- Molecular formula:
- C22H40ClN
- IUPAC Name:
- N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride
- Reference substance name:
- unknown constituent
- IUPAC Name:
- unknown constituent
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- other: human patients of dermatologists
- Sex:
- male/female
- Details on test animals and environmental conditions:
- During year 1977, 2806 patients were studied with patch test among 30873 dermatological patients. Four major groups of allergens were able to consider, following the incidence in their power of sensitize. Third groups with medium incidence contains Benzalkonium chloride in particular.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Concentration / amount:
- 0.1%
Challenge
- Route:
- epicutaneous, open
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 2806 patients who had been diagnosed with eczema suspect of contact etiology
- Details on study design:
- To each patient we applied the Spanish standard patch rests, based on the o nes used by the I. C. D. R. G. with the addition of some ext ra noxas, which are still widely resorted to in Spain. We used the Al-Test patch produced by the "lmeco Astra Agency Co." -Sweden-, the "Microspore Surgical 1530" tape and the "Staedtler Noris 323" porous-pen.
- Challenge controls:
- Four major groups of allergens were able to consider,following the incidence in their power of sensitize. First group with strong incidence include: Nickel, Chromate, Cobalt, T. M. T. D., P. P. D. A., Mercapto mix. , and Wood tars. Second and third groups with medium incidence contain: Caines, Carbonates, Neomycin, Balsam of Peru, Mercury, Lanolin, Naphtyl mix ., Formaldehyde, Benzalkonium chloride, P. P. D. A. mix, and Turpentine. Four group show very low incidence substances, as: Epoxi, Sulfonamides, Et ilendiamine, Parabens, Chinoform, Colophony and Cinnamon oil.
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Benzalkonium chloride: index of sensitization observed in 60 cases on 2806 (2,13%)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 66
- Total no. in group:
- 2 086
- Clinical observations:
- positive sensitization, not specified
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2.13% in 2806 patients who had been diagnosed with eczema suspect of contact etiology
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- negative control
- Dose level:
- 0.1% pet. for benzalkonium chloride, up to 25% for other chemicals tested
- No. with + reactions:
- 1 701
- Total no. in group:
- 2 806
- Clinical observations:
- positive sensitization to one of the chemicals tested, not specified
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Patients with negative reactions to all patches: 1105 (39,37%).
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- positive control
- Dose level:
- 0.1% pet. for benzalkonium chloride, up to 25% for other chemicals tested
- No. with + reactions:
- 1 701
- Total no. in group:
- 2 806
- Clinical observations:
- positive sensitization to one of the chemicals tested, not specified
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Patients with one or more positivities: 1701 (60,62%)
Applicant's summary and conclusion
- Conclusions:
- In a repeated patch tested according to Standard International Contact Dermatitis Research Group procedure (HRIPT), 66 of the 2806 were sensitive to Benzalkonium Chloride (2.13%)
- Executive summary:
Patch tested according to Standard International Contact Dermatitis Research Group procedure, 66 of the 2806 eczema patients were sensitive to Benzalkonium Chloride
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