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EC number: 700-064-6 | CAS number: 2105830-60-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- EC Number:
- 700-064-6
- Cas Number:
- 2105830-60-0
- Molecular formula:
- Not applicable as this is a UVCB substance
- IUPAC Name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- Reference substance name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- IUPAC Name:
- [TN]Multiester P97-463[/TN][SPEC][/SPEC][AM]100 %[/AM]
- Details on test material:
- Multiester P97-463
Batch No: NB2890-61
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- The formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and the density of the test substance. The test substance could technically not be dosed undiluted as delivered by the sponsor. In order to obtain homogeneity, the test substance formulations were heated in a water bath with a maximum temperature of 65 °C
for a maximum of 25 minutes. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Stepwise treatment of 2 groups of 3 females
- Statistics:
- No statistical analysis was performed. The method used is not intended to allow the calculation of a precise LD50 value.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: based on act. ingr.
- Mortality:
- No mortality occurred.
- Clinical signs:
- No clinical signs were observed in the first group of three females. The second group showed hunched posture on Days 1 and 2 and uncoordinated movements on Day 1. There is no indication in the raw data that could explain the difference in clinical signs observed between both groups.
- Body weight:
- The mean body weight gain shown by the animals over the study period was considered to be normal.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information EU DSD and UN GHS Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of Multiester P97-463 in Wistar 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 Multiester P97-463 does not have to be classified and has no obligatory labeling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC). - Executive summary:
The study was carried out based on the guidelines described in: OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method" EC, Council Directive 67/548/EEC, Annex V, B.1 tris (2004) "Acute Toxic Class Method" EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity" JMAFF guidelines (2000) including the most recent partial revisions.
Multiester P97-463 was administered by oral gavage to two subsequent groups of three female Wistar 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. No clinical signs were observed in the first group of three females. The second group showed hunched posture on Days 1 and 2 and uncoordinated movements on Day 1. There is no indication in the raw data that could explain the difference in clinical signs observed between both groups. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of Multiester P97-463 in Wistar 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 Multiester P97-463 does not have to be classified and has no obligatory labeling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).
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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