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EC number: 283-626-9 | CAS number: 84696-07-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cupressus sempervirens, Pinaceae.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles and considered sufficiently reliable for the purpose of hazard assessment.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Skin prick test according to Malling (1993) - Commercial and in-house allergenic extracts from Cupressaceae family were used for skin prick testing and specific IgE detection in six groups of subjects exposed to a high concentration of Cupressaceae pollen.
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Cupressaceae pollen
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 713
- Sex: Male and female
- Age: 2-82 years (mean ± SD, 28.5 ± 17.1; median value 26) - Clinical history:
- - Patients included were those complaining of symptoms related to upper or lower respiratory tract disorders or conjunctival disease, all suspected of being allergic in nature.
- Controls:
- - Positive and negative controls were histamine solution (10 mg/mL) and 50 % glycerinated solution in water, respectively.
- Route of administration:
- dermal
- Details on study design:
- - Skin prick tests were performed according to standard procedure (Malling, 1993).
- Commercial and in-house allergenic extracts were used for skin prick testing and specific IgE detection in six groups of subjects exposed to a high concentration of Cupressaceae pollen.
- Specific IgE detection was performemed according to the procedure (Bousquet et al., 1990; Kleine-Tebbe et al., 1992; Merret et al., 1993; Olivieri et al., 1993; Salkie et al., 1994)
- Patients were asked to avoid antihistamine intake for at least 7 days before testing (8 weeks for astemizole). Test evaluation was done after 15 minutes.
Results and discussion
- Results of examinations:
- - Positive response: Sensitization effects, 31.5 % of the patients had positive responses to the in-house extract of the test material; 25.9 % had positive responses to the commercial extract.
- Four commercial and two in-house Cupressus sempervirens pollen extracts showed low cutaneous reactivity.
- Positive test results were recorded in 26 % of the 713 subjects tested. C. arizonica in-house pollen extracts gave rise to larger cutaneous reactions. Furthermore, the skin prick test response was positive in a greater number of subjects (38 %) of the same group.
- Six commercial immunoassays were able to detect specific IgE to C. sempervirens in rates ranging from 8.1% to 81.1%. Specific IgE to C. arizonica was detected by means of an in-house immunoenzymatic method in 70.3% of 54 patients with suspected "cypress" allergy, and specific IgE to C. sempervirens was detected in 75.9% of these patients by using a commercial system.
- High rates of cross-reactivity within the Cupressaceae family were recorded with both in vivo and in vitro tests.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test condition, Cupressaceae pollen induced skin sensitization in human.
- Executive summary:
Skin prick test was conducted in 713 male and female patients with Cupressaceae pollen.
Sensitization effects were observed: 31.5% of the patients had positive responses to the in-house extract of the test material; 25.9% had positive responses to the commercial extract.
Under the test condition, Cupressaceae pollen induced skin sensitization in human.
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