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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 203-685-6 | CAS number: 109-59-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The source substance is used to supplement old but reliable data on the registered substance itself. The source substance is a structural isomer of the target substance differing in branching of the propyl end group of the molecule. (The target substance is isopropyl whereas the source substance is n-propyl.) The source and target substance therefore have common functional groups, identical molecular weights and similar physicochemical properties and common breakdown pathways. (The latter are discussed in more detail in read across justification documents appended to other end points in this dossier. For the relatively simple toxicological end point of acute dermal toxicity, a detailed read across justification does not seem warranted, especially when there is actually a reliable study that could stand alone on the target substance
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target substance: Isopropoxyethanol (subject of this dossier)
Source subtance: 2-n-propoxy ethanol (SMILES CCCOCCO, CAS 2807-30-9)
Purity: Both substances as tested are >99% pure and do not contain impurities that could impact the validity of the read across.
3. ANALOGUE APPROACH JUSTIFICATION
Both substances have similar acute oral LD50 values and similar dermal penetration rates.
4. DATA MATRIX
Rat oral LD50 values, EGiPE (target substance): >2mg/kgbw, 5.1g/kgbw. EGnPE (source substance): 3.1g/kgbw (fasted), 6.2g/kgbw (not fasted)
Percutaneous absorption rate, human skin: EGiPE (target substance) 0.2 - 0.3mg/cm2/hr. EGnPE (source substance): 0.2 - 1.0 mg/cm2/hr.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Full study report available with detailed information on study. Not to GLP. Rationale for using a read across substance is included in overall remarks section.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- , no significant deviations noted from the information available.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratory animals Inc, Denver, PA
- Age and weight at study initiation: no data
- Housing: metal cages
- Diet (e.g. ad libitum): Purina lab chow, ad libitum
- Water: ad libitum
- Acclimation period: 3 weeks
ENVIRONMENTAL CONDITIONS
- no data - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: 3.5x4 inch area.
- Type of wrap if used: Pad in close contact with skin occluded with dental dam wrap. Substance injected under dam into pad then dam edges sealed with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with cotton wool. No washing.
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 541, 1092, 2184, 4368 mg/kg (based on 5.2, 10.5, 21, 42 mmol/kg)
- No. of animals per sex per dose:
- 5
- Control animals:
- other: no but other substances tested in same study acted as reference 'controls'
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Twice per day for mortality, once per day for abnormal signs. Body weights recorded before treatment and on days 7 & 14 (end of study).
- Necropsy of survivors performed: yes as well as animals that died.
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology - Statistics:
- LD50 calculated using the method of Thompson and Weil (Biometrics 8, 51-4 (1952))
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 337 mg/kg bw
- 95% CL:
- > 1 009 - < 1 768
- Mortality:
- no details reported.
- Clinical signs:
- other: At lower doses: anorexia, slight depression, cyanosis, ataxia, soft faeces. At higher doses: salivation, nasal discharge, iritis, significant depression, llaboured breathing, prostration.
- Gross pathology:
- Redish colour fluid was observed in the urinary bladder. Also see table below
- Other findings:
- - Potential target organs: see table below
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 dose response is quite sudden with no deaths or adverse pathology noted at a dose of 307mg/kg.
- Executive summary:
In a single 24 hour exposure dermal toxicity study, male NZ white rabbits were exposed to 2 -n-propoxyethanol. The LD50 value is shown below. Sub-lethal effects included at lower doses anorexia, slight depression, cyanosis, ataxia, soft faeces, and at higher doses salivation, nasal discharge, iritis, significant depression, laboured breathing, and prostration.. The only significant pathology was to the kidney and GI tract.
Results synopsis
LD50: 1337mg/kg
Summary of gross pathology:
Dose (mmol/kg) | 5.2 | 10.5 | 21 | 42 | ||
Number of rabbits examined/with pathology | 5/2 | 5/5 | 5/5 | 5/5 | ||
Thymus - red spots on surface | 1 |
|||||
Spleen - enlarged | 1 |
|||||
Liver - pale | 1 | |||||
Liver - margin discoloured (tan) | 1 | |||||
Kidney - cortex and medulla wide zone between | 3 | |||||
Kidney - corex and medulla poor differentiation between | 1 | 4 | ||||
Kidney - enlarged | 3 | |||||
Kidney - dark red | 1 | 5 |
|
|||
Stomach - lining red or dark red | 1 | 5 | ||||
Stomach - dark red | 4 | |||||
Intestines, large and small - red discoloration | 1 | 5 | 3 |
Data source
Materials and methods
Test material
- Reference substance name:
- 2807-3-9
- IUPAC Name:
- 2807-3-9
- Reference substance name:
- 2-(propyloxy)ethanol
- EC Number:
- 220-548-6
- EC Name:
- 2-(propyloxy)ethanol
- Cas Number:
- 2807-30-9
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-propoxy-1-ethanol
- Details on test material:
- - Name of test material (as cited in study report): 2-Propoxyethanol
- Molecular formula (if other than submission substance): C3H7)CH2CH20H
- Molecular weight (if other than submission substance): 104.15
- Source: Tennessee Eastman Company (Kingsport, TN)
- Analytical purity: 99.5%
- Impurities (identity and concentrations): 2-n-butoxyethanol, triethylene glycol n-butyl ether, isopropyl ethanol
Constituent 1
Constituent 2
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Remarks:
- rat
- Effect level:
- ca. 1 300 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
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.