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Diss Factsheets
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EC number: - | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 December 2018 - 18 April 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was performed in accordance with the OECD Principles of Good Laboratory Practice as accepted by Regulatory Authorities throughout the European Union, United States of America (FDA and EPA), Japan (MHLW, MAFF and METI) and other countries that are signatories to the OECD Mutual Acceptance of Data Agreement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 216-823-5
- EC Name:
- 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- Cas Number:
- 1675-54-3
- Molecular formula:
- C21H24O4
- IUPAC Name:
- 2,2'-[propane-2,2-diylbis(4,1-phenyleneoxymethylene)]dioxirane
- Reference substance name:
- Fatty acids, linseed-oil, polymers with bisphenol A, epichlorohydrin and soya fatty acids
- EC Number:
- 613-885-9
- Cas Number:
- 66070-79-9
- Molecular formula:
- (C15 H16 O2 . C3 H5 Cl O . Unspecified . Unspecified)x
- IUPAC Name:
- Fatty acids, linseed-oil, polymers with bisphenol A, epichlorohydrin and soya fatty acids
- Test material form:
- liquid: viscous
- Details on test material:
- Clear colourless viscous liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test System:
Condition: Outbred, SPF-Quality
Source: Charles River Deutschland, Sulzfeld, Germany
nulliparous and non-pregnant
Age at the Initiation of Dosing: Young adult animals (approximately 10 weeks old)
Fasting period before study: overnight fast immediately before dosing and for approximately 3 to 4
hours after dosing
- Housing: in groups of up to 3 in suspended solid floor polycarbonate cages containing sterilized sawdust as bedding material
- Diet: SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany; ad libitum throughout the study, except for the period of overnight prior to dosing and until 3-4 hrs post dose administration
- Water: Municipal tap-water was freely available to each animal via water bottles
- Acclimation period: at least 5 days
Environmental Conditions
Temperature range: 20 to 21°C
Relative Humity range: daily mean relative humidity of 27 to 53%
12-hour light/12-hour dark cycle
Ten or greater air changes per hour with 100% fresh air (no air recirculation)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- two consecutive groups of three female Wistar Han rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: CLinical Observations at 0, 2 and 4 hr after dosing on day 1 and then once daily. Morbidity and mortality checks were made twice daily, early and late during normal working
days, and once daily at weekends and public holidays.
Frequency of weighing: Days 1 (predose), 8 and 15
days, and once daily at weekends and public holidays.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths
- Clinical signs:
- other: Hunched posture and piloerection were noted for the animals on Days 1 and/or 2
- Gross pathology:
- No Abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. - Executive summary:
The objective of this study was to assess the toxicity of the test item when administered in a single dose to female rats at one or more defined dosages. The study was carried out in compliance with the guidelines described in:
OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method".
EC No 440/2008, part B: "Acute Oral Toxicity, Acute Toxic Class Method".
EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity".
JMAFF Guidelines (2000), including the most recent revisions.
Soya/Linseed Oil Fatty Acid-BADGE reaction product was administered by oral gavage to
two consecutive groups of three female Wistar Han rats at 2000 mg/kg body weight. Animals
were subjected to daily observations and weekly determination of body weight. Macroscopic
examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Hunched posture and piloerection were noted for the animals on Days 1 and/or 2.
The body weight gain shown by the animals over the study period was considered to be
similar to that expected for normal untreated animals of the same age and strain.
No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of Soya/Linseed Oil Fatty Acid-BADGE reaction product in Wistar Han
rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed
5000 mg/kg body weight.
Based on these results, Soya/Linseed Oil Fatty Acid-BADGE reaction product does not have
to be classified and has no obligatory labelling requirement for acute oral toxicity according
to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of
the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on
classification, labelling and packaging of items and mixtures (including all amendments).
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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