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EC number: 293-625-5 | CAS number: 91081-22-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted according to OECD guideline and subject to GLP audit study, tested with the source substance CAS 65997-04-8. Based on the structural similarities and the fact that the target substance is an adduct of the source substance, this study is considered valid for read-across.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Rosin, fumarated
- EC Number:
- 266-040-8
- EC Name:
- Rosin, fumarated
- Cas Number:
- 65997-04-8
- Molecular formula:
- Not applicable. UVCB
- IUPAC Name:
- Rosin, fumarated
- Details on test material:
- - Name of test material (as cited in study report): Rosin, fumarated
- Substance type: Chemically modifed UVCB
- Physical state: amber crystalline solid
- Analytical purity: Commercial samples
- Lot/batch No.: TWR01075-15FTOR-9.19.01
- Expiration date of the lot/batch: 21 September 2002-
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Marget, Kent, CT9 4LT
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 150-250g
- Fasting period before study: yes, overnight
- Housing: individually in suspended cages with stainless steel grid tops and solid bottoms. Analysis of bedding is presented and is not considered to contain additional substances in sufficient concentration to have any influence on the outcome of the study.
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Maintenance Diet (Special Diets Services Limited, Essex CM8 3AD, UK), ad libitum.
- Water (e.g. ad libitum): From domestic mains, ad libitum.
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 06 August 2002 To: 29 August 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: determined to be the most appropriate
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 20ml/kg
DOSAGE PREPARATION (if unusual): The required amount of test item was weighed and ground using a pestle and mortar and the requisite amount of MZO was added. Formulations were mixed by manual inversion until visibly homogeneous. The formulations were magnetically stirred and warmed prior to dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females used in total
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Viability: frequently on the day of dosing and thereafter once each day.
Clinical observations: Frequently on Day 1 and daily thereafter until Day 15.
Body weights: Immediately before dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes on Day 15. Examination of the thoracic and abdominal organs and tissues in situ. Carcasses were discarded following this procedure.
- Other examinations performed: none - Statistics:
- No formal statistical analysis was conducted.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: No treatment related clinical signs noted during observation period
- Gross pathology:
- No findings were noted at necropsy.
- Other findings:
- no data
Any other information on results incl. tables
The test item was administered orally in a single dose, by means of a gavage, followed by a 14 day observations period. The dose volume was increased from 10ml/kg to 20ml/kg after the first animal was dosed as this formulation was very difficult to get through the gavage.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 was determined to be > 2000 mg/kg in female rats.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of rosin, fumarated cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.
In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category. - Executive summary:
In an acute oral toxicity study, 5 female Sprague-Dawley rats were given a single oral dose of rosin, fumarated (CAS 65997-04-8) in maize oil at a dose of 2000 mg/kg. There were no treatment related clinical signs, necropsy findings or changes in body weight.The oral LD50 was determined to be > 2000 mg/kg in female rats.
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