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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 irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance
- Justification for type of information:
- Frequently performed cosmetic efficacy assay with human exposure
- 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 by capillary 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
- 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
- Details on test animals or test system and environmental conditions:
- healthy female test persons of different age and different skin type
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- other: glycerin
- Controls:
- yes, concurrent vehicle
- yes, concurrent negative control
- Amount / concentration applied:
- 0%, 33%, 50%, 66%, 100%
- Duration of treatment / exposure:
- daily, for 2 weeks on their right forearm
- Number of animals:
- 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.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 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 on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.
- Other effects:
- moisturizing effect
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.
- Executive summary:
In a clinical test in 80 humans, Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 13/03/2018-14/03/2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- 1. SOFTWARE
and MODEL (incl. version number)
: Danish QSAR Database, is able to predict the Severe Skin irritation in Rabbit using a battery of three QSAR prediction models - SciQSAR, LeadScope and CASE Ultra.
2. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL :
OCC(O)C(O)CO
3. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
- Defined endpoint: skin irritation. Even if the endpoints of skin and eye irritation/corrosion are not dependent on each other, the result for skin does hints about the irritation/corrosion potential of the same substance for eye. A positive result for skin irritation may hint (but not always) about a possible irritation effect on the eye. Possibility for the three models to determine the Severe Skin irritation in Rabbit. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Danish QSAR Database, is able to predict the Severe Skin irritation in Rabbit using a battery of three QSAR prediction models - SciQSAR, LeadScope and CASE Ultra. Even if the endpoints of skin and eye irritation/corrosion are not dependent on each other, the result for skin does hints about the irritation/corrosion potential of the same substance for eye. A positive result for skin irritation may hint (but not always) about a possible irritation effect on the eye
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- OCC(O)C(O)CO
- Irritation parameter:
- other:
- Remarks on result:
- no indication of irritation
- Remarks:
- QSAR predicted results
- Other effects / acceptance of results:
- Not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Erythritol was predicted as non-irritant to the skin. The results were just reported to add further weight to the results derived for eye irritation on this substance using OECD QSAR ISafeRabbit Eye irritation HA-QSAR.
- Executive summary:
Based on all the QSAR models incoroporated into Danish QSAR Database, the query chemical was predicted as non-irritant to the skin. The results were just reported to add further weight to the results derived for eye irritation on this substance using OECD QSAR ISafeRabbit Eye irritation HA-QSAR.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 13/03/2018-14/03/2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
- Justification for type of information:
- 1. SOFTWARE
2. MODEL (incl. version number) : iSafeRabbit Eye Irritation High Accuracy-QSAR (HA-QSAR) v1.1.
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL : OCC(O)C(O)CO
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
- Defined endpoint: Eye Irritation/Corrosion potential
- Unambiguous algorithm:
- Defined domain of applicability:
- Appropriate measures of goodness-of-fit and robustness and predictivity:
- Mechanistic interpretation:
- Experimental validation : QSAR) model v1.1 validated for the chemical group in question, i.e. polyols (alcohols). The QSAR is based on validated data for a current training set of 295 chemicals derived from eye irritation/corrosion studies on rabbits.
5. APPLICABILITY DOMAIN
- Descriptor domain: The test substance 1,2,3,4-Butanetetrol is within applicability domain of the iSafeRabbit® eye irritation/corrosion prediction model, with the exception of the the descriptor domain of water solubility. However, the solubility of 3.63 ×107 mg/L, is in close proximity of the maximum WS value of the domain range (2.4 × 107) which means the prediction may considered as an extrapolation.
- Structural fragment domain : 1,2,3,4-Butanetetrol is a four carbon alcohol of the type polyol, which is inside the structural fragment domain of iSafeRabbit® eye prediction model.
- Mechanistic domains: N/A
- Statistics : The statistical validation of the iSafeRabbit® eye irritation/corrosion prediction model was evaluated by quantifying the number of substances for which the output of the eye irritation model corresponds to a correct prediction, based on the fully validated in-vivo eye irritation result for each substance. This number of correct predictions is then divided by the total number of substances in the training set for the relevant chemical group, i.e. alcohols and given as a number and as a percentage. This percentage is 80% of correct predictions
6. ADEQUACY OF THE RESULT
QSAR model adapted specifically to test guideline: OECD 405, EU B.4. then result can be interpreted in term of eye irritation potential - Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: REACH Guidance on QSARs R.6
- Version / remarks:
- QSAR following OECD 405
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- OCC(O)C(O)CO
- Irritation parameter:
- other: cell body burden and cytoxicity
- Run / experiment:
- NA
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- QSAR predicted results
- Other effects / acceptance of results:
- Not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The erythritol is reliably predicted as non-irritant to the eye
- Executive summary:
The erythritol was reliably predicted as non-irritant to the eye with iSafeRabbit HA-QSAR v1.1 for Eye Irritation/Corrosion, model adapted specifically to test guideline: OECD 405, EU B.4.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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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