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Diss Factsheets
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EC number: 938-572-7 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-29 November 2017 (In-life)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- EC Number:
- 231-621-7
- EC Name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- Cas Number:
- 7658-03-9
- Molecular formula:
- C7H16O3
- IUPAC Name:
- 2-ethyl-2-(methoxymethyl)propane-1,3-diol
- Reference substance name:
- 2-ethylpropane-1,3-diol
- EC Number:
- 220-038-3
- EC Name:
- 2-ethylpropane-1,3-diol
- Cas Number:
- 2612-29-5
- Molecular formula:
- C5H12O2
- IUPAC Name:
- 2-ethylpropane-1,3-diol
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Rat, Hsd: Sprague Dawley SD
Sex: Females (nulliparous and non-pregnant)
Age: 6-7 weeks old
Supplier: Envigo RMS s.r.l., San Pietro al Natisone (UD), Italy
Breeder: Envigo RMS B.V., Kreuzelweg 53, 5961 NM Horst, Netherlands
Date of arrival: 02 November 2017
Weight range at arrival: 157-164 g
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period
Animals per cage: 3 during the study; up to 5 during acclimatisation
Housing: Polisulfone solid bottomed cages measuring 59.5×38×20 cm, with nesting material provided into suitable bedding bags
Water: Drinking water supplied to each cage via a water bottle; Water supply ad libitum
Diet: 4 RF 18 diet supplied ad libitum throughout the study
Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes: Approximately 15 to 20 air changes per hour
Temperature: Range 22 °C±2 °C
Relative humidity: Range 55%±15%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE: water (softened by reverse osmosis).
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10mL/kg bw
- Justification for choice of vehicle: based on solubility - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Two groups of 3 females (4-hour fasted)
- Control animals:
- no
- Details on study design:
- A first group of 3 female animals of approximately 8 week of age, was dosed at a level of 2000 mg/kg bw (Step 1). Mortality did not occur. A second group, similarly composed, was then dosed at the same dose level (Step 2). No mortality occurred. No further doses were investigated since the objective of the study had been achieved.
- Statistics:
- Not required
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred in either group of three female rats.
- Clinical signs:
- other: In the first group of three rats, some clinical signs were observed in all animals on the day of dosing. Hunched posture and ataxia were recorded from 30 minutes after dosing up to 4 hours after dosing, piloerection from two hours up to 4 hours and decre
- Gross pathology:
- No abnormalities were observed at necropsy.
Any other information on results incl. tables
Summary of findings
Group |
Rats |
Mortality |
1 |
3 female |
0/3 |
2 |
3 female |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No mortality occurred in the six animals following dosing at 2000 mg/kg bw. Decreased activity, ataxia, hunched posture and piloerection were observed in all animals on the day of dosing but had resolved by Day 2 of the study. The acute toxicity estimate (ATE) is therefore >2000 mg/kg bw. No classification is required for acute toxicity according to CLP criteria.
- Executive summary:
The acute toxicity of DMP Tech. (reaction mass of 2-ethyl-2 -(methoxymethyl)-propane-1,3-diol and 2 -ethylpropane-1,3 -diol) was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period. A first group of three female rats was initially dosed at 2000 mg/kg bw (Step 1). No mortality occurred. Some clinical signs were observed in all animals on the day of dosing: hunched posture and ataxia were recorded from 30 minutes after dosing up to 4 hours after dosing, piloerection from two hours up to 4 hours and decreased activity at two hours after dosing. In addition, one animal showed rales at 30 minutes after dosing. A second group of three female rats was dosed at the same dose level (Step 2). No mortality occurred. Decreased activity was recorded in all animals from 30 minutes up to 4 hours after dosing, ataxia from 30 minutes up to two hours after dosing, hunched posture and piloerection at 4 hours after dosing. Bodyweight changes recorded during the study were within the expected range for this strain and age of animals. Gross necropsy did not reveal any effects of treatment. The acute oral LD50 of DMP Tech. was therefore found to the >2000 mg/kg bw under the conditions of this study.
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