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EC number: 225-967-8 | CAS number: 5187-23-5
- 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
5 -ethyl-1,3 -dioxane-5 -methanol is of low acute oral toxicity: an acute oral LD50 > 2000 mg/kg bw is reported. A waiver is proposed for acute dermal toxicity in line with REACH guidance, as no classification can be predicted for this endpoint based on the findings of the acute oral toxicity study. A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral route, and that inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance.
5 -ethyl-1,3 -dioxane-5 -methanol is of low acute oral toxicity: an acute oral LD50 > 2000 mg/kg bw is reported. A waiver is proposed for acute dermal toxicity in line with REACH guidance, as no classification can be predicted for this endpoint based on the findings of the acute oral toxicity study. A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral route, and that inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Batch 9201; clear / colourless liquid
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Møllegaard Breeding Centre ApS, Ejby, DK-4623 Lille, Skensved
Age at study initiation: 6 - 7 weeks old
Weight at study initiation: 146 -163 g
Fasting period before study: Rats were fasted for approximately 18 hours prior to dosing
Housing: Housed in Macrolone type III cages (42 x 26 x 15cm), with 2 or 3 to a cage. Males and females were kept separated
Diet (e.g. ad libitum): Complete rodent diet "Altromin 1314" ad libitum
Water (e.g. ad libitum): Drinking water acidified with hydrochloric acid to pH 2.5 ad libitum
Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 21 ± 3°C
Humidity (%): 55 ± 15%
Air changes (per hr): 10 times per hour
Photoperiod (hrs dark / hrs light): 12 hour photoperiod
IN-LIFE DATES: No information provided. - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water.
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 2000 mg/kg body weight. - Amount of vehicle (if gavage): No information provided. - Justification for choice of vehicle: No information provided. - Lot/batch no. (if required): No information provided. - Purity: No information provided. MAXIMUM DOSE VOLUME APPLIED: 10ml/kg body weight.DOSAGE PREPARATION (if unusual): No information provided. CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: No information provided.
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: Bodyweights were recorded on Day 0, Day 7 and Day 14. Observations on clinical signs of toxicity were made 1, 2, 3 and 6 hours and daily thereafter from Day 1 to 14.- Necropsy of survivors performed: Any rats found dead during the 14 day observation period were subjected to a autopsy examination. All surviving rats were subjected to gross necropsy examination at the end of the 14 day osbervation period.- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No information provided.
- Statistics:
- Not required
- Preliminary study:
- A dose-range finding study was conducted at a dose level of 2000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female rat died during the treatment.
- Clinical signs:
- other: At the 1 hour observation, 8 rats were comatose, 1 rat showed sedation, pinched abdomen and laboured respiration and 1 rat showed ataxia and pinched abdomen. At the 3 hour observation, 2 rats were still comatose, 2 rats showed ataxia and piloerection and
- Gross pathology:
- Autopsy of the rat that died from the treatment revealed no pathological findings that could be attributed to the treatment. No gross pathological findings related to the treatment wee observed following autopsy of the surviving rats.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study, the oral LD50 of CTF was >2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of CTF in rats was determined according to the method recommended in OECD Guideline 401. CTF was administered orally by gavage to 5 male and 5 female Wistar rats at a concentration of 2000 mg/kg bw. The test animals were observed for a period of 14 days following exposure and observations were made at regular intervals, including observations on body weight, clinical signs and any clinical signs of toxicity. All test animals were subjected to a gross necropsy at termination on day 14. With only one female rat found dead during the course of the exposure, the oral LD50 was above 2000 mg CTF/kg body weight under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- A high quality modern GLP- and guideline-compliant study is available for this endpoint.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of 5 -ethyl-1,3 -dioxane-5 -methanol (CTF) in rats was determined according to OECD Test Guideline 401 (Dyring Jacobsen, 1992). CTF was administered orally by gavage to 5 male and 5 female Wistar rats at a concentration of 2000 mg/kg bw. Animals were observed for a period of 14 days following exposure and observations were made at regular intervals, including observations of body weight, clinical signs and any signs of toxicity. Only one female rat was found dead during the course of the exposure: no pathological findings attributable to treatment were observed. All test animals were subjected to a gross necropsy at termination on Day 14. No gross pathological findings were observed in treated animals. The oral LD50 was determined to be >2000 mg/kg bw under the conditions of this study.
Acute dermal toxicity
No study is available. A waiver is proposed for this endpoint based on REACH guidance, based on the low acute oral toxicity. CTF is not classified for acute oral toxicity (LD50 >2000 mg/kg bw); it can also be assumed that classification for acute dermal toxicity is not required. Specific testing for acute dermal toxicity is therefore not required.
Acute inhalation toxicity
A waiver is proposed for acute inhalation studies in accordance with Column 2 of Annex VIII of the REACH Regulation on the basis that acute toxicity data are available for the oral route. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance. The substance is a non-volatile liquid and the use pattern indicates that significant inhalation exposure is unlikely.
Justification for classification or non-classification
The oral LD50 of 5 -ethyl-1,3 -dioxane-5 -methanol in rats is > 2000 mg/kg bw. CTF is classified for acute oral toxicity in Category 5 according to GHS; classification for acute oral toxicity is not required under the CLP Regulation.
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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