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Diss Factsheets
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EC number: 205-737-3 | CAS number: 149-32-6
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- clinical study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2011
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Prior to the start of the trials, the initial skin moisture of the test persons (female) was measured with the aid of a Corneometer® which detects the skins moisture retention in the superficial layers of the stratum corneum as deep as 10-20 μm (to be ensured that the measurement is not influenced bycapillary blood vessels). For two weeks, the human applied emulsions with different glycerin:ERYTHRITOL ratios (3:0; 2:1; 1:1; 1:2; 0:3) daily on their right forearm. Four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion. The main purpose of this study is to determine the ability of the substance to hydrate human skin,
as part of a cosmetic test. The authors of the study the authors of the study also evaluate the skin irritation potential of the substance. Given the animal model used (human) and the duration of the test (2 weeks), it can be considered reliable in assessing the potential for irritation of the skin by erythritol - GLP compliance:
- not specified
- Remarks:
- Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- LLNA assay not avaialble, but clinical data used in a weight of evidence approach with sensitization data
- Specific details on test material used for the study:
- different glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3) then between 25% and 75%
- Species:
- other: human
- Sex:
- female
- Details on test animals and environmental conditions:
- healthy female test persons of different age and different skin type
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: glycerin
- Concentration / amount:
- 25 to 75%
- Day(s)/duration:
- daily for 2 weeks
- Adequacy of challenge:
- other: up to 75% (non irritating substance)
- No. of animals per dose:
- 10 persons per glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3)
- Details on study design:
- For statistical reasons four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion.
- Challenge controls:
- see above
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 25 to 75%
- No. with + reactions:
- 0
- Total no. in group:
- 80
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Remarks:
- clinical test on volunteers to support substance safety and efficacy: no negative/control group
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- clinical test on volunteers to support substance safety and efficacy: no negative/control group
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- People who are sensitive or allergic to certain chemical components can have skin irritation, rashes or other allergic reactions when getting in contact with certain substances. None of the 80 test persons having erythritol (at 25% and up to 75%) on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.
- Executive summary:
In a clinical open test in 80 volunteers, application onto forearm of women. People who are sensitive or allergic to certain chemical components can have skin irritation, rashes or other allergic reactions when getting in contact with certain substances. None of the 80 test persons having erythritol (at 25% and up to 75%) on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.
- Endpoint:
- skin sensitisation, other
- Remarks:
- skin puncture test and intradermal (ID) titration skin test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2001
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Case reports and clinical study on 2 Japanese volunteers who had experienced multiple reactions to erythritol containing foods: specific IgE antibody assay
- GLP compliance:
- not specified
- Remarks:
- available publication which does not precise GLP compliance status, nevertheless judged as relevant for REACH compliance
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- skin puncture eventually followed by oral administration (challenge)
- Species:
- other: human volunteer
- Sex:
- male/female
- Details on test animals and environmental conditions:
- A 28-year-old woman developed generalized urticaria after eating various ERT-containing foods.
A 50-year-old man experienced 3 episodes of generalized urticaria, 2 of which included physician-documented hypotension (systolic BP readings, 90 and 74) after eating ERT-containing foods. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 100 mg/mL puncture skin test with more than 40 lots of erythritol (100 mg/mL in 50% glycerine)
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Clinical observations:
- small amounts of histamine were released in a dose-dependent manner with both synthetic ERT (maximum release, 17%) and fermentation-derived ERT (maximum release, 23%).
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 100 mg/mL intradermal titration skin test with erythritol solutions in saline solution between 4 and 20 mg/mL
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Clinical observations:
- This first volunteer’s peripheral blood leukocytes released <8% total histamine when challenged in vitro with serial dilutions of erythritol
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- cumulative dose, 1.6 g by oral route
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Clinical observations:
- facial swelling and urticaria
- Remarks on result:
- not determinable because of methodological limitations
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- puncture skin tests with more than 40 lots of erythritol (100 mg/mL in 50% glycerine)
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- negative control
- Dose level:
- 100 mg/mL punture skin test - 7 healthy control subjects, 2 groups
- No. with + reactions:
- 14
- Total no. in group:
- 14
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- anecdotal and unconfirmed reports of adverse reactions to ERT-containing products (estimated prevalence, <1 per million people) have appeared. Collectively, these data suggest that ERT might function as an allergen or hapten to mediate IgE-dependent anaphylactic reactions. Alternatively,a non–IgE-mediated mechanism of tissue mast cell or blood leukocyte activation might be operative. The pathophysiologic mechanisms underlying these reactions remain obscure.
- Executive summary:
In a clinical study in 2 case reported of oral allergy to erythritol persons, contracdictory results on skin sensitization in skin puncture test and intradermal (ID) titration skin test.
Anecdotal and unconfirmed reports of adverse reactions to erythritol-containing products (estimated prevalence, <1 per million people) have appeared. Collectively, these data suggest that ERT might function as an allergen or hapten to mediate IgE-dependent anaphylactic reactions. Alternatively,a non–IgE-mediated mechanism of tissue mast cell or blood leukocyte activation might be operative. The pathophysiologic mechanisms underlying these reactions remain obscure for the publication authors.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Regarding low probability of:
- exposure by inhalation (boi:ling point 330°C, vapour pressure 33,6 mPa, particule size D50 = 550,5 µm)
- sensitization in humans (prevalence <1 per million people)
no significant respiratory sensitization potential is expected
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