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Diss Factsheets
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EC number: 203-768-7 | CAS number: 110-44-1
- 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- other: a retrospective study
- Adequacy of study:
- supporting study
- Study period:
- from1 January 1990 - 31 December 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Patch test data and data from the patients with history of dermatitis. Criteria was not specified
Data source
Reference
- Reference Type:
- publication
- Title:
- Patch testing with preservatives, antimicrobials and industrial biocides. Results from a multicentre study
- Author:
- Schnuch A., J.Geier, W.Uter and P.J.Frosch
- Year:
- 1 998
- Bibliographic source:
- British Journal of Dermatology 1998; 138: 467–476.
Materials and methods
- Study type:
- cohort study (retrospective)
- Endpoint addressed:
- skin sensitisation
- Principles of method if other than guideline:
- Clinical data collected from 01/01/1990 to 31/12/1994 from 24 departments of the Information Network of Departments of Dermatology Germany (IVDK). Patch test from 11,437 patients with allergic dermatitis were exposure 24 or 48 h to sorbic acid (Vehicle: petrolatum) and readout after 24 or 48 h (72 h after application). Reaction Index was calculated. Statistical analysis was performed using the SASTM system (SAS Institute, Cary, NC, U.S.A.) on the IBM host computer of the Department of Medical Informatics of the University of Göttingen.
Reaction Index: Reaction Index: "where the number of allergic reactions is related to the number of questionable and irritant reactions." - GLP compliance:
- no
Test material
- Specific details on test material used for the study:
- not specified
Method
- Type of population:
- other: patients with history of dermatitis
- Ethical approval:
- not specified
- Details on study design:
- See principles of method if other than guidelines
- Exposure assessment:
- estimated
- Details on exposure:
- exposure 24 or 48 h to sorbic acid in petrolatum
- Statistical methods:
- not specified
Results and discussion
- Results:
- Of 11437 patient, 85 were positive (0.7 %), 93 with questionable or irritant reaction and a reaction index 0.0
- Confounding factors:
- not specified
- Strengths and weaknesses:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Study cannot be used for classification. Description of response (mild/moderate/intense) not well described, results at different time points not well described, data are not sufficient to assess false positives.
Of 11437 patient, 85 were positive (0.7 %), 93 with questionable or irritant reaction and a Reaction.
Index 0.0.
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.
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