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EC number: 270-451-8 | CAS number: 68440-34-6
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004". In accordance with Section 1 (0.5), Annex I of Regulation (EC) 1907/2006 (REACH), this study was considered reliable with restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- other: CIR Cosmetic Ingredient Revie, peer-reviewed in EU RAR
- Title:
- Submission of data by CTFA. Unpublished safety data on the Lithium Stearate Group. Schwartz-Peck Prophetic Patch Test and Draize-Shelanski Repeated Insult Patch Test. Zinc Stearate (10 percent) in eye shadow 923 - 100.
- Author:
- CTFA
- Year:
- 1 976
- Bibliographic source:
- Busch, J.T., CIR Cosmetic Ingredient Review (1982). Int J Toxicol 1 (2), 143-177.
- Reference Type:
- other: communication
- Title:
- Zinc stearate (10 %) in eye shadow 923-100
- Author:
- CIR Safety.org, Cosmetic Ingredient Review 1101 17th St. N. W. Suite 412 Washington D. C. 20036-4702, USA
- Year:
- 2 010
- Bibliographic source:
- Communication to bibliographic source Busch, J.T, CIR Cosmetic Ingredient Review (1982), Int J Toxicol 1 (2), 143-177.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Two eyeshadow formulations, each containing 10 % zinc stearate, were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 91051-01-3
- Cas Number:
- 91051-01-3
- IUPAC Name:
- 91051-01-3
- Reference substance name:
- Fatty acids, C16-18, zinc salts
- EC Number:
- 293-049-4
- EC Name:
- Fatty acids, C16-18, zinc salts
- IUPAC Name:
- 293-049-4
- Details on test material:
- - Name of test material (as cited in study report): Zinc stearate
Substances named zinc stearate or zinc distearate are considered equal to substance fatty acid, C16-18, zinc salts. Commercially produced stearic acid is always a mixture of what chemically was called stearic acid (C18) and palmitic acid (C16). In practice, the description “Fatty acids, C16-18, zinc salts” registered under CAS no 91051- 01-3 is a more exact fit with commercial zinc stearate (c.f. EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN, page 7).
No further information on the test material was stated.
Constituent 1
Constituent 2
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 202 subjects participated in the Schwartz-Peck Prophetic Patch Test and 99 subjects participated in the Draize-Shelanski Repeated Insult Patch Test.
No further information on subjects was stated. - Clinical history:
- Not stated
- Controls:
- Not stated
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test)
No further information on the study design was stated.
Results and discussion
- Results of examinations:
- Results from the Schwartz-Peck Prophetic Patch Test: Virtually 0 reactions in 202 subjects
Results from Draize-Shelanski Repeated Insult Patch Test: Virtually 0 reactions in 99 subjects
Applicant's summary and conclusion
- Conclusions:
- The results showed that two eyeshadow formulations, each containing 10 % zinc stearate, which were tested by means of the Schwartz-Peck Prophetic Patch Test and the Draize-Shelanski Repeated Insult Patch Test, resulted in virtually 0 reactions in the subjects.
Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004: Based on the accepted derogation and the fact that zinc oxide is not a skin sensitiser, it is consequently concluded that zinc distearate is not likely to be skin sensitising, and therefore does not need to be classified/labelled. This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic products is without reported skin sensitisation effects.
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