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EC number: 701-284-5 | CAS number: 2137881-70-8
- 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

Carcinogenicity
Administrative data
Description of key information
Data are avaialable for formates
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 708 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Klimisch score = 1. Modern study compliant with current test guidelines and GLP
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Potassium diformate (1:2) did not show potential for carcinogenicity in two long-term rodent feeding studies. This result can be extrapolated to formic acid. No carcinogenic potential is predicted for trimethylopropane or pentaerythritol or their corresponding esters. Due to the lack of carcinogenic associated with its components,the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acidis not predicted to have any carcinogenic potential.On this basis, the substance does not meet the criteria for classification for carcinogenicity according to Regulation 1272/2008/EC.
Additional information
The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid consists of formic acid, propylidynetrimethanol-esters and pentaerythritol-esters. The toxicity of the propylidynetrimethanol-esters and pentaerythritol-esters is predicted to be comparable to propylidynetrimethanol and pentaerythritol respectively. Due to the corrosivity of formic acid, carcinogenicity studies using this substance are scientifically unjustified. The carcinogenic potential of formic acid has been determined by read-across to studies on the formate salts. Data from carcinogenicity studies using formate salts and the assessment of the carcinogenic potential of propylidynetrimethanol and pentaerythritol are considered appropriate to meet the REACH Annex VII-X data requirements for the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid.
Formic acid
Due to the corrosivity of formic acid, studies requiring repeated oral dose testing are not justified for scientific reasons and on animal welfare grounds. Formate salts have been used in studies requiring repeated oral dosing. NOAEL values obtained in such studies may be used to calculate the NOAEL for the formate anion which may be read across to formic acid, taking into account stoichiometry and formula weights. Read-across to the findings from carcinogenicity studies using potassium formate is considered appropriate to determine the carcinogenic potential of the formate ion, and hence formic acid.
There are two combined chronic oral feeding toxicity and oncogenicity studies using potassium diformate (1:2). These tests include the combined 104-week chronic toxicity and oncogenicity rat study (50 Crl: HanWist(Glx: BRL) BR rats/sex/concentration at concentrations of 0, 50, 400, and 2000 mg/kg bw/day (BASF, 2002a) and the combined oral feed 80-week chronic toxicity and oncogenicity mouse study (51 Crl: CD-1 (ICR) BR mice/sex/concentration at concentrations of 0, 50, 400, and 2000 mg/kg bw per day; BASF, 2002b). The pattern of mortality did not indicate any treatment-related effect in either the rat or mouse. The spectrum of tumours was generally consistent with that expected in rats or mice of these strains. There were no tumours of unusual nature or incidence indicative of specific target organ carcinogenicity in the stomach or any other tissue at any concentration level in any species or sex. The NOAEL for carcinogenicity was 2000 mgpotassium diformate/kg bw/day in both sexes. This dose is equivalent to 708 mgformic acid/kg bw/day, or1415 mgformate anion/kg bw/day.
Potassium diformate (1:2) did not show potential for carcinogenicity in two long-term rodent feeding studies. This result can be extrapolated to formic acid
Propylidynetrimethanol & pentaerythritol
There are no studies available which have investigated the carcinogenic potential of propylidynetrimethanol or pentaerythritol. These substances did not show mutagenic activity in genotoxicity studies and (histo) pathological alterations indicative for a potential carcinogenic effect were not observed in the available repeated dose toxicity studies. No testing has therefore been triggered according to Annex X of Regulation(EC) No. 1907/2006. Similarly, a lack of carcinogenic potential is predicted for the corresponding esters.
The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid
Based on the available evidence its component substances, the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is not expected to have any carcinogenic potential.
Justification for selection of carcinogenicity via oral route
endpoint:
The reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl
diformate and formic acid consists of formic acid,
propylidynetrimethanol-esters and pentaerythritol-esters. Data from
carcinogenicity studies using formate salts and the assessment of the
carcinogenic potential of propylidynetrimethanol and pentaerythritol is
considered appropriate to meet the REACH Annex VII-X data requirements
for the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl
diformate and formic acid.
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.

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