Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-605-8 | CAS number: 3159-62-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: GLP-status not known, guideline not known, information from a peer-reviewed, published review article. Notable limitations in design and/or reporting, reliability not known.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- not specified
- Principles of method if other than guideline:
- - Method: Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects. A 24-hour challenge patch was then applied after two weeks rest and observations made at 24, 48 and 72 hours.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium stearate
- EC Number:
- 212-490-5
- EC Name:
- Sodium stearate
- Cas Number:
- 822-16-2
- IUPAC Name:
- sodium stearate
- Test material form:
- other: Stick deodorant formulation
- Details on test material:
- No data reported
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- No data reported
- Clinical history:
- No data reported
- Controls:
- No data reported
- Route of administration:
- dermal
- Details on study design:
- - Method: Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects. A 24-hour challenge patch was then applied after two weeks rest and observations made at 24, 48 and 72 hours.
Results and discussion
- Results of examinations:
- - Induction results: 59 slight, one moderate and one severe erythema reactions occurred during the two week induction period.
- Challenge results: Seven light erythema reactions were seen at 24 hours after the challenge patch application, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative.
Applicant's summary and conclusion
- Conclusions:
- Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects causing 59 slight, one moderate and one severe erythema reactions. A 24-hour challenge patch was then applied after two weeks rest and seven light erythema reactions were seen at 24 hours, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative.
- Executive summary:
Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects causing 59 slight, one moderate and one severe erythema reactions. A 24-hour challenge patch was then applied after two weeks rest and seven light erythema reactions were seen at 24 hours, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative. No information on the test methods used is available in the publication (CIR 1982). However, this information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.
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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