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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
- Study period:
- May - June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
- Test material form:
- liquid
- Details on test material:
- - Molecular weight: 2800-3000
- CAS Name: Castor oil, polymer with tetrahydromethyl-1,3-isobenzofurandione
- Description: Very viscous amber liquid
- Test substance storage: At room temperature in the dark under nitrogen
- Stebility under storage conditions: Stable
- Expiry date: 01 January 2009
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Husbandry
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 +/- 3.0°C (actual range: 19.3 - 21.3°C), a relative humidity of 30-70% (actual range: 31 - 80%) and 12 hours artificial ftuorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary ftuctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these
fluctuations were considered not to have affected the study integrity.
- Accommodation
Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm,) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and
paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham MiIIltd), Surrey, United Kingdom).
Acclimatization peried was at least 5 days belere start 01 treatment under laboratory conditions.
- Diet
Free access to pelleted rodent diet (SM R/M-Z lrom SSNIFF® Spezialdiaten GmbH, Soest, Germany).
- Water
Free access to tap water.
Results of analysis for each batch of diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificales and results of analysis are retained in the NOTOX archives.
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.
- Method: Oral gavage, using plastie feeding tubes
- Fasting: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance.
- Frequency: Single dosage, on Day 1
- Dose level (volume): 2000 mg/kg (10 mL/kg) body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3 per step
- Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females.
The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account lor determination of the time interval between the dose groups. - 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
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- 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:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of the substance 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 the substance 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.
The substance 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 the Substance 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 the substance 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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