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EC number: 614-657-1 | CAS number: 68609-08-5
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Expert statement
- Adequacy of study:
- key study
- Study period:
- 2009-06-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Expert Statement, no study
- Details on test animals or test system and environmental conditions:
- Not applicable
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Not applicable
- No. of animals per sex per dose / concentration:
- Not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Not applicable
- Details on dosing and sampling:
- Not applicable
- Preliminary studies:
- Not applicable
- Details on absorption:
- The test item is a hard viscous mass at room temperature with a molecular weight of 681.02 g/mol. Vapour pressure was calculated to be 0.131 Pa at 25 °C.The partition coefficient (logPow = 2.36) was determined using the HPLC-method. The substances water solubility was determined to be 13.8 mg/l.
As the substance is a solid, vapour pressure is extremely low and the boiling point is at 249 °C (> 150 °C), little exposure via inhalation is expected. Even though the log Pow indicates that some absorption directly across the respiratory tract epithelium can occur, the high molecular weight indicates that the substance will hardly become bioavailable via the inhalation route. Further, the substance showed low toxicity after oral and dermal administration. Together this indicates low systemic availability after inhalation and if bioavailable, low toxicity via this route of administration.
Based on physical-chemical properties the test item absorption across the skin is likely to be low, especially due to the molecular weight > 500 g/mol and low water solubility. No toxicity, neither local nor systemic, was observed following dermal application of 2000 mg/kg bw up to the limit dose. - Details on distribution in tissues:
- Administered orally, the test item is not likely to dissolve in the stomach easily, due to its low water solubility. As only dissolved substance is available for adsorption, the quantity of the test item to become bioavailable via the oral route is expected to be low. The high molecular weight does not favour passive diffusion across the gastrointestinal tract. Most likely very low amounts of the test item will become bioavailable and most of the test item ingested will be eliminated through faeces. Respectively, toxicity to orally administered test item is low, as shown in acute and subacute toxicity tests. The compounds estimated log BCF-value of 3.84 (EPIWIN v4.00) indicates that the test item is not likely to bioaccumulate, if becoming bioavailable.
Low amounts of bioavailable test item, after e.g. ingestion, are likely to be metabolised and parent compound and degradation products are expected to slowly distribute via systemic circulation. Based on molecular weight and water solubility, the substance will most likely be excreted via faeces. Metabolism may transform the test item into more polar degradation products. Likely pathways are reactions such as cytochrome P-450-dependent monooxygenase enzyme mediated oxidative ring opening and/or cleavage at the amide side-chain. Parent compound and metabolites formed in phase I metabolic reactions may be rendered more polar by phase II metabolic activity in subsequent reactions. The parent compound or possible metabolites may undergo conjugation (e.g. with glutathione), before being excreted in urine or bile. - Details on excretion:
- It is unlikely that the test item is metabolised to more reactive (toxic) products. This assumption is supported by results obtained in oral and dermal toxicity studies and three in vitro tests. In acute and subacute in vivo studies toxicity was moderate to low. In an Ames test and a chromosome aberration assay no significant increase in toxicity was noted in the presence of a rodent microsomal S9-fraction, when compared to incubation without S9-fraction. Together, this data indicates that formation of reactive metabolites is rather unlikely.
Based on the substance’s structure and associated physical-chemical characteristics, very low to low amounts of the test item will become bioavailable through inhalation, upon contact to skin or following oral ingestion. When bioavailable, the substance or its metabolites are expected to distribute slowly, with excretion via urine or bile (polar conjugated forms) and via faces (high molecular weight forms). Bioaccumulation is not likely. - Metabolites identified:
- not specified
- Conclusions:
- Based on the substance’s structure and associated physical-chemical characteristics, very low to low amounts of the test item will become bioavailable through inhalation, upon contact to skin or following oral ingestion. When bioavailable, the substance or its metabolites are expected to distribute slowly, with excretion via urine or bile (polar conjugated forms) and via faces (high molecular weight forms). Bioaccumulation is not likely.
- Executive summary:
The test item is a hard viscous mass at room temperature with a molecular weight of 681.02 g/mol. Vapour pressure was calculated to be 0.131 Pa at 25 °C. The partition coefficient (logPow = 2.36) was determined using the HPLC-method. The substances water solubility was determined to be 13.8 mg/L.
As the substance is a solid, vapour pressure is extremely low and the boiling point is at 249 °C (> 150 °C), little exposure via inhalation is expected. Even though the log Pow indicates that some absorption directly across the respiratory tract epithelium can occur, the high molecular weight indicates that the substance will hardly become bioavailable via the inhalation route. Further, the substance showed low toxicity after oral and dermal administration. Together this indicates low systemic availability after inhalation and if bioavailable, low toxicity via this route of administration.
Based on physical-chemical properties the test item absorption across the skin is likely to be low, especially due to the molecular weight > 500 g/mol and low water solubility. No toxicity, neither local nor systemic, was observed following dermal application of 2000 mg/kg bw up to the limit dose.
Administered orally, the test item is not likely to dissolve in the stomach easily, due to its low water solubility. As only dissolved substance is available for adsorption, the quantity of the test item to become bioavailable via the oral route is expected to be low. The high molecular weight does not favour passive diffusion across the gastrointestinal tract. Most likely very low amounts of the test item will become bioavailable and most of the test item ingested will be eliminated through faeces. Respectively, toxicity to orally administered BADGE with IPDA is low, as shown in acute and subacute toxicity tests. The compounds estimated log BCF-value of 3.84 (EPIWIN v4.00) indicates that the test item is not likely to bioaccumulate, if becoming bioavailable.
Low amounts of bioavailable test item, after e.g. ingestion, are likely to be metabolised and parent compound and degradation products are expected to slowly distribute via systemic circulation. Based on molecular weight and water solubility, the substance will most likely be excreted via faeces. Metabolism may transform the test item into more polar degradation products. Likely pathways are reactions such as cytochrome P-450-dependent monooxygenase enzyme mediated oxidative ring opening and/or cleavage at the amide side-chain. Parent compound and metabolites formed in phase I metabolic reactions may be rendered more polar by phase II metabolic activity in subsequent reactions. The parent compound or possible metabolites may undergo conjugation (e.g. with glutathione), before being excreted in urine or bile.
It is unlikely that the test item is metabolised to more reactive (toxic) products. This assumption is supported by results obtained in oral and dermal toxicity studies and three in vitro tests. In acute and subacute in vivo studies toxicity was moderate to low. In an Ames test and a chromosome aberration assay no significant increase in toxicity was noted in the presence of a rodent microsomal S9-fraction, when compared to incubation without S9-fraction. Together, this data indicates that formation of reactive metabolites is rather unlikely.
Based on the substance’s structure and associated physical-chemical characteristics, very low to low amounts of the test item will become bioavailable through inhalation, upon contact to skin or following oral ingestion. When bioavailable, the substance or its metabolites are expected to distribute slowly, with excretion via urine or bile (polar conjugated forms) and via faces (high molecular weight forms). Bioaccumulation is not likely.
Reference
Description of key information
Based on the substance’s structure and associated physical-chemical characteristics, very low to low amounts of the test item will become bioavailable through inhalation, upon contact to skin or following oral ingestion. When bioavailable, the substance or its metabolites are expected to distribute slowly, with excretion via urine or bile (polar conjugated forms) and via faces (high molecular weight forms). Bioaccumulation is not likely.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic Assessment of the test item
1. General
The epoxy resin amine adduct is produced by mixing the basic resin Bisphenol-A-Diglycidylether (BADGE) with the amine Isophorondiamine (IPDA). The substance is used as hardener component for epoxy adhesives in industrial applications, such as construction industry, only. When reacted with a curing agent, the test item forms a strong inert coating adhesive.
2. Toxicological Profile of the test item
In an acute oral toxicity study with rats the LD50-value was determined between 300 to 2000 mg/kg bw with a cut-off value of 500 mg/kg bw. An acute dermal toxicity study revealed a LD50-value of > 2000 mg/kg bw (limit dose). In a skin irritation study in rabbits, topical application of the substance was well tolerated and no irritation or corrosion effects were observed. In an eye irritation test in rabbits no irritant effects were observed either. A local lymph node assay revealed skin sensitising properties. In a bacterial mutagenicity test (Ames test), a cytogenetic assay using mammalian cells (chromosome aberration test) and an in vitro mammalian cell gene mutation test (mouse lymphoma assay) no mutagenic, clastogenic or genotoxic effects were noted, in the presence and absence of metabolic activation (rodent microsomal S9-fractions). In a subacute oral toxicity study the test item caused no adverse toxic effects in male or female CRL:(WI) BR rats after 28-day subsequent oral (by gavage) administration of 25 mg/kg bw/day, 80 mg/kg bw/day or 200 mg/kg bw/day. However, a slight statistically significant test item influence was found on the white blood cell picture in male animals at 200 mg/kg bw/day. Changes in the female 200 mg/kg bw/day dose group were comparable, but not statistically significant. Similar changes were also observed in one single female animal at 80 mg/kg bw/day. At 200 mg/kg bw/day, test item related changes in enzyme activity of alanine aminotransferase were also observed. None of the findings were considered adverse. At 25 mg/kg bw/day, there were no test item related effects. The no observed effect level (NOEL) was 25 mg/kg bw/day. The no observed adverse effect level (NOAEL) was 200 mg/kg bw/day. In a reproduction/developmental toxicity screening test with the test item in CRL:(WI) BR rats the NOAEL for parental effects was determined at 80 mg/kg bw/day. For reproduction parameters the NOAEL was 150 mg/kg bw/day. For pup growth rate, the NOAEL was 80 mg/kg bw/day.
3. Toxicokinetic Analysis of the test item
The test item is a hard viscous mass at room temperature with a molecular weight of 681.02 g/mol. Vapour pressure was calculated to be 0.131 Pa at 25 °C. The partition coefficient (logPow = 2.36) was determined using the HPLC-method. The substances water solubility was determined to be 13.8 mg/L. As the substance is a solid, vapour pressure is extremely low and the boiling point is at 249 °C (> 150 °C), little exposure via inhalation is expected. Even though the log Pow indicates that some absorption directly across the respiratory tract epithelium can occur, the high molecular weight indicates that the substance will hardly become bioavailable via the inhalation route. Further, the substance showed low toxicity after oral and dermal administration. Together this indicates low systemic availability after inhalation and if bioavailable, low toxicity via this route of administration. Based on physical-chemical properties the test item absorption across the skin is likely to be low, especially due to the molecular weight > 500 g/mol and low water solubility. No toxicity, neither local nor systemic, was observed following dermal application of 2000 mg/kg bw up to the limit dose. Administered orally, the test item is not likely to dissolve in the stomach easily, due to its low water solubility. As only dissolved substance is available for adsorption, the quantity of the test item to become bioavailable via the oral route is expected to be low. The high molecular weight does not favour passive diffusion across the gastrointestinal tract. Most likely very low amounts of the test item will become bioavailable and most of the test item ingested will be eliminated through faeces. Respectively, toxicity to orally administered test item is low, as shown in acute and subacute toxicity tests. The compounds estimated log BCF-value of 3.84 (EPIWIN v4.00) indicates that the test item is not likely to bioaccumulate, if becoming bioavailable. Low amounts of bioavailable test item, after e.g. ingestion, are likely to be metabolised and parent compound and degradation products are expected to slowly distribute via systemic circulation. Based on molecular weight and water solubility, the substance will most likely be excreted via faeces. Metabolism may transform the test item into more polar degradation products. Likely pathways are reactions such as cytochrome P-450-dependent monooxygenase enzyme mediated oxidative ring opening and/or cleavage at the amide side-chain. Parent compound and metabolites formed in phase I metabolic reactions may be rendered more polar by phase II metabolic activity in subsequent reactions. The parent compound or possible metabolites may undergo conjugation (e.g. with glutathione), before being excreted in urine or bile. It is unlikely that the test item is metabolised to more reactive (toxic) products. This assumption is supported by results obtained in oral and dermal toxicity studies and three in vitro tests. In acute and subacute in vivo studies toxicity was moderate to low. In an Ames test and a chromosome aberration assay no significant increase in toxicity was noted in the presence of a rodent microsomal S9-fraction, when compared to incubation without S9-fraction. Together, this data indicates that formation of reactive metabolites is rather unlikely. Based on the substance’s structure and associated physical-chemical characteristics, very low to low amounts of the test item will become bioavailable through inhalation, upon contact to skin or following oral ingestion. When bioavailable, the substance or its metabolites are expected to distribute slowly, with excretion via urine or bile (polar conjugated forms) and via faces (high molecular weight forms). Bioaccumulation is not likely.
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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