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Diss Factsheets
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EC number: 256-418-0 | CAS number: 49663-84-5
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for 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:
- Inhibitory effect of zinc oxide on contact allergy due to colophony
- Author:
- Soderburg T A, Elemros T, Gref R and Hallmans G
- Year:
- 1 990
- Bibliographic source:
- Contact Dermatitis: 23: 346-351
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Internationally accepted methods cited in Fregert S (1981)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- This study was conducted in patients for the determination of inhibitory effect of of Zinc oxide on contact allergy due to colophony
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): Zinc oxide (Merck, Darmstadt. FRG)
- Analytical purity: > 99 %
Constituent 1
Method
- Type of population:
- other: Patients with suspected contact allergy
- Ethical approval:
- confirmed, but no further information available
- Remarks:
- Approved by the local ethical committee
- Subjects:
- - Number of subjects exposed: 14
- Sex: 13 females and one male
- Age: Females mean age: 40 yr; Male: 49 yr
- Race: No data
- Demographic information: No data
- Other: Patients with strong test reactions to colophony were not included. - Clinical history:
- - History of allergy or casuistics for study subject or populations: Earlier verIfied moderate patch test reactions to colophony, were included in the study.
- Symptoms, onset and progress of the disease: No patient had signs of active dermatitis at the time of the study. - Controls:
- - Colophony (10 and 60 %)
- Zinc oxide in white petrolatum (10 %)
- Adhesive mass (10 %) - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test
ADMINISTRATION
- Type of application: Other
- Description of patch: Portuguese colophony 10 % was mixed with zinc oxide 0.01, 0.1, 1.0 and 10 % (w/w white petrolatum) and patch tested on the same patients. 200 mg of the substance to be tested was dissolved in 99.5 % ethanol. Thereafter, the ethanol was evaporated in a steady stream of N2 until 0.2 mL remained. White petrolatum (1.8 g) was thereafter added.
- Vehicle / solvent: 99.5 % ethanol
- Concentrations: 0.01, 0.1, 1.0 and 10 % (w/w in white petrolatum)
EXAMINATIONS
- Grading/Scoring system:
(-) Negative
(+) Erythema and infiltration or erythema, infiltration and papules
(++) Erythema, infiltration and vesicles
- Statistical analysis: No data
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: The patch pieces were applied directly on the back and removed together with the other patches after 2 days, assessment of the reactions being made 3 d after application.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 14
- Total number of subjects: 14
Any other information on results incl. tables
For details see the reference for:
- Occlusive adhesive zinc-medicated tapes evaluated for inhibitory effect of Zinc oxide on contact allergy.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, Zinc oxide (10 %) applied alone did not cause any erythema, infiltration or papules (patch test reactions)
- Executive summary:
A study was conducted in patients for the determination of inhibitory effect of of Zinc oxide on contact allergy due to colophony.
14 patients with verified moderate contact allergy to colophony were patch tested with adhesive mass (10%), Portuguese colophony (10%), zinc oxide (10%), purified resin acids (10%), and Portuguese colophony (10%), in combination with zinc oxide.
Only 3 patients reacted to the adhesive mass, whereas all patients showed a positive patch test reaction to Portuguese colophony. A combination of zinc oxide (10%) with Portuguese colophony (10%) provoked a positive patch test reaction in only 5 of these 14 patients. However, negative
patch test reaction in all 14 patients was observed with Zinc oxide (10%).
Under the test conditions, Zinc oxide (10 %) applied alone did not cause any erythema, infiltration or papules (patch test reactions).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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