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EC number: 928-726-1 | CAS number: 1179913-28-0
- 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 oral LD50 of the test substance was determined to be >2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 15, 2016 to March 30, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Lot Number: #210162718
Reaction products of linseed-oil fatty acids, 4,4'-methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity 100% as per definition of UVCB
Appearance: brown liquid - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: Velaz Prague, Czech Republic
Age at first dose: 8-12 weeks
Acclimation: 5 days prior to the start of treatment
Room temperature: 22 ± 2° C, relative humidity: 55 ± 10%
The light regimen was set to a 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany), water: tap water - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test substance had been administered, food was withheld for further 3-4 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- All 6/6 females survived the limit dose of 2000 mg/kg
- Clinical signs:
- other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered
- Gross pathology:
- No changes were observed
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not require classification
- Conclusions:
- Under the study conditions, the LD50 of the test substance was greater than 2000 mg/kg, after single oral administration to rats.
- Executive summary:
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. Six females were administered the test substance at a concentration of 2000 mg/kg bw by gavage. Animals were observed individually immediately after the administration of the test substance and then 0.5, 1, 2, and 4 h later. Then each animal was inspected daily for the next 14 days. Individual weights of animals were determined shortly before the test substance was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded. All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. All 6/6 females survived the limit dose of 2000 mg/kg. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered. The body weights of all animals were increasing during the study. No body weight losses were observed between first and second week after administration. No changes were observed at necropsy. Under the study conditions, the LD50 of the test substance was greater than 2000 mg/kg bw, after single oral administration to rats (Hozova, 2016).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Guideline compliant study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. Six females were administered the test substance at a concentration of 2000 mg/kg bw by gavage. Animals were observed individually immediately after the administration of the test substance and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Individual weights of animals were determined shortly before the test substance was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded. All test animals were subjected to gross necropsy. All gross pathological changes were recorded for each animal. All 6/6 females survived the limit dose of 2000 mg/kg. Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered. The body weights of all animals were increasing during the study. No body weight losses were observed between first and second week after administration. No changes were observed at necropsy. Under the study conditions, the LD50 of the test substance was greater than 2000 mg/kg bw, after single oral administration to rats (Hozova, 2016).
Justification for classification or non-classification
Based on the results of an acute oral toxicity study, the test substance does not need to be classified for this endpoint according to CLP criteria (EC 1272/2008).
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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