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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 221-140-0 | CAS number: 3010-96-6
- 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
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 500 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral Studies
The acute oral toxicity of 2,2,4,4-tetramethyl-1,3-cyclobutanediol (TMCD) is well understood. The key study followed OECD guideline 425 and GLP assurances. The results of that study indicated the material to have an estimated LD50 in rats of approximately 1,500 mg/kg with a 95% confidence interval of 1,043 – 4,350 mg/kg per day. Surviving animals showed no gross pathology and primary clinical signs in animals that died consisted on hypoactivity, haunched posture, and piloerection. Several other acute oral studies were conducted in rats between 1958 and 1963. In these studies mortality was induced at dose levels of 800 mg/kg and above. This value is in approximately in the range of the recent guideline study. Interestingly though is that the clinical signs in these studies indicate evidence of neurotoxicity (ataxia, tremors, and convulsions) in the animals that died. Such clinical signs of neurotoxicity are consistent with what was observed in the 28 day study at dose levels of 750 -1,000 mg/kg per day. All animals in these studies died within minutes to hours after administration of test material and may also be agonal in nature. The absence of such signs in the key study may simply be that the material is excitatory at lower doses but ultimately induces inhibitory neural responses at higher doses as noted by hypoactivity prior to death at the 1,500 mg/kg doses in the key study. These older studies only utilized one animal per dose and were not well documented. The acute toxicity of TMCD was also evaluated in mice in two older studies (1958 and 1960). These studies also only used one animal per dose. Like rats neurological stimulation was noted (ataxia and convulsions). However, mice seemed to be even more sensitive to the test material with death occurring at dose levels of 200 mg/kg in one study and 400 mg/kg in the other study.
Dermal Studies
Two acute dermal toxicity studies were identified. The key study being conducted in 2006 followed OECD guideline 402 and GLP assurances, while the later was conducted in 1960 and was primarily designed to assess dermal irritation potential. Neither study showed evidence of toxicity or death with the key study using the highest dose (2,000 mg/kg) as well as the most animals (10; 5/sex).
Justification for classification or non-classification
The oral acute toxicity value (1500 mg/kg bw) fell within the criteria for Acute Category 4.
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.