Registration Dossier
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EC number: 904-153-2 | 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

Endpoint summary
Administrative data
Description of key information
The substance is of low toxicity. An acute oral LD50 of >2000 mg/kg bw is reported. The dermal LD50 of TMP is reported to be >10000 mg/kg bw. A waiver is proposed for acute inhalation toxicity in accordance with Column 2 of Annex VIII of the REACH Regulation as acute toxicity data are available for the oral and dermal routes. 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
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Additional information
Acute oral toxicity
The acute oral toxicity of Polyol TD was investigated in a GLP study conducted according to OECD Guideline 423 (Robinson, 2010). Polyol TD was administered to two groups of female Sprague-Dawley rats as a single dose of 2000 mg/kg bw. The animals were observed for signs of reaction to treatment for 15 days after administration. There were no unscheduled deaths during the observation period. Adverse signs were restricted to salivation at 5 min post dose, which was observed in all animals. Body weight gain was considered to be acceptable for rats of this age and strain and there were no macroscopic abnormalities recorded at necropsy. Under the conditions of the study the median lethal oral dose level (the LD50) of Polyol TD in Sprague-Dawley rats was considered to exceed 2000 mg/kg bw.
Acute toxicity: dermal
The acute dermal toxicity of trimethylolpropane was determined in groups of 4 male albino rabbits (Elsea, 1956). The test material was moistened with distilled water and applied as a paste to the shaved, intact abdominal skin of the rabbits. Dose levels were 1.0, 2.15, 4.64 and 10.0 g/kg bw, the exposure period was 24 hours and the rabbits were observed for 7 days following exposure.
Dermal exposure resulted in a very mild degree of dermal irritation, that had subsided within 24 hours. There was no evidence of systemic toxicity, no mortalities occurred during the study, and there were no remarkable findings at gross necropsy. The acute dermal LD50 of trimethylolpropane is therefore greater than 10.0 g/kg bw in male rabbits.
No data are available for Polyol TD or CTF, however additional testing for acute dermal toxicity is not proposed. Based on the low acute oral toxicity of Polyol TD (with only minimal clinical signs seen at the limit dose of 2000 mg/kg bw), low acute dermal toxicity can also be predicted. Based on general theoretical considerations, dermal absorption of the individual components is likely to be less rapid and less extensive than oral absorption. Marked kinetic differences are unlikely, further indicating low dermal toxicity. This assumption is also confirmed by the very low acute dermal toxicity of the component TMP. It is therefore concluded that additional testing for acute dermal toxicity is not required scientifically and cannot be justified on grounds of animal welfare.
Acute inhalation toxicity
A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation as acute toxicity data are available for the oral and dermal routes. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance.
Justification for classification or non-classification
The Reaction mass of 2-ethylpropane-1,3-diol(DMP) and 5-ethyl-1,3-dioxane-5-methanol(CTF) and propylidynetrimethanol(TMP) does not meet the criteria for classification according to Directive 67/548/EEC or Regulation 1272/2008/EC.
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