Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 484-360-8 | CAS number: -
- 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)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Toxicokinetic Assessment
- Adequacy of study:
- key study
- Study period:
- February 28, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Toxicokinetic Assessment by a certified toxicologist.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
- Reference Type:
- other: amendment
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
- Objective of study:
- other: Assessment of toxicokinetic behaviour
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ECB EU Technical Guidance Document on Risk Assessment, 2003
- GLP compliance:
- no
Test material
- Test material form:
- liquid
- Details on test material:
- - Name of test material: Reaction products of Fatty acids, C16-18 and C18-unsatd. and reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol
- Physical state: Light brown liquid
Constituent 1
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- For risk assessment purposes, the oral and dermal absorption is set at 10% and the inhalation absorption at 100%.
Any other information on results incl. tables
The substance is a mixture of polyols reacted with fatty
acids C16-18 and C18-unsaturated. This toxicokinetic
assessment is based on the physical/chemical properties as
determined for the test substance and it is anticipated that
these properties are representative for all constituents in
this substance.
The water solubility is very low (<1 mg/L). Since in general
a substance needs to be dissolved before it can be taken up
from the gastro-intestinal tract, it is unlikely that the
test substance will show a high systemic exposure after oral
administration. As ionized substances do not easily pass
the GI wall, the presence of free hydroxyl groups in the
molecule will further impair the absorption. Although no
clear molecular weight can be defined, it is not to be
expected that the molecular size is that high that passage
through biological membranes will further be lowered. Its
highly lipophilic character (logPow > 6.5) indicates that
uptake by micellular solubilisation may be of particular
importance. For risk assessment purposes the oral absorption
of the test substance is set at 10%. The results of the
toxicity studies do not provide reasons to deviate from this
proposed oral absorption factor.
No significant cleavage of the ester bound(s) is to be
expected in the gastro-intestinal tract, due to the limited
water solubility. Also liberation of formaldehyde (from the
cyclic monopentaformal and cyclic homopentaformal group) is
anticipated to be limited. In the case absorption of the
test substance occurs, cleavage of the ester bonds and
conjugation is to be expected. The test substance, the
resulting metabolites and conjugation products will be
excreted via feces (high molecular substances) or via urine
(low molecular substances).
The low vapour pressure (< 1.47 x 10-3 Pa) indicates that
the availability of the substance for inhalation will be
limited. However, once present in the respiratory tract, the
low water solubility (<1 mg/L) indicates a potential for
accumulation, while its lipophilic character (logPow > 6.5)
indicates the potential for absorption directly across the
respiratory tract epithelium. For risk assessment purposes
the inhalation absorption of the test substance is set at
100% as a worst case assumption.
The low water solubility (<1 mg/L) and its highly lipophilic
character (logPow > 6.5) do not facilitate dermal
absorption. As the molecular weight cannot really be
defined, it cannot be assessed whether or not the criteria
for 10% dermal absorption as given in the Reach guidance (MW > 500 and
logPow >4) are met. However, based on the logPow> 6.5,
a molecular weight most probably not far below 500 and the
knowledge that in general dermal absorption is not higher
compared to oral absorption, 10% dermal absorption of the
test substance is proposed for risk assessment purposes. The
results of the toxicity studies do not provide reasons to
deviate from this proposed dermal absorption factor.
Based on the present available data, no additional
conclusions can be drawn on the metabolism and excretion of
the test substance after dermal and inhalatory absorption.
Applicant's summary and conclusion
- Conclusions:
- For risk assessment purposes:
Absorption oral = 10%
Absorption dermal = 10%
Absorption inhalation = 100%
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Lai gan ECHA nodrošina Jūsu valodā daudz tiešsaistes dokumentu, daļa no šīs tīmekļa lapas ir pieejama tikai angļu valodā. Lai iegūtu plašāku informāciju par ECHA daudzvalodības praksi, spiediet .
Laipni lūdzam ECHA tīmekļa vietnē! Šī vietne netiek pilnībā atbalstīta programmā Internet Explorer 7 (un agrākās versijās) “Lūdzu, nomainiet to ar jaunāku Internet Explorer versiju.”
Šajā tīmekļa vietnē tiek izmantoti sīkfaili, lai nodrošinātu Jums vislabāko lietojumu mūsu tīmekļa vietnēs.
Uzziniet vairāk par sīkfailu lietošanu.