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EC number: 696-130-6 | CAS number: 1364681-45-7
- 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:
- From 08 October 2012 to 08 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- EC Number:
- 696-130-6
- Cas Number:
- 1364681-45-7
- Molecular formula:
- Unspecified
- IUPAC Name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- Details on test material:
- - Name of test material (as cited in study report): Resin acids and rosin acids, reaction products with formaldehyde, calcium salts
- Physical state: Solid / offwhite
- Analytical purity: 96.0 % w/w determined by Mass spectroscop
- Lot/batch No.: DMG 7245
- Expiration date of the lot/batch: July 05, 2016
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
- Homogeneity: The homogeneity of the test item preparation will be determined indirectly by concentration control analysis.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Animal strain: Wistar / Cri:WI (Han)
- Source: Charles RiverWiga GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (female animals approx. 10 weeks)
- Mean weight at study initiation: Group 1: 186.7 ± 4.04; Group 2: 179.3 ± 0.58 g
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing; Makrolon cage, type Ill
- Diet: VRF1 (P); SDS Special Diets Services, Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30- 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From 08 October 08 2012 to 30 October 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- Ph.Eur.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Justification for choice of vehicle: Good homogeneity in olive oil Ph.Eur.
- Form of administration: Suspension
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test item preparation was produced for each application group shortly before application by stirring with a high speed homogenizer (Ultra-Turrax) and a magnetic stirrer. Additionally the homogeneity of the test item preparation during application was ensured by stirring with a magnetic stirrer.
Stability of the test item preparation: The stability of the test item in the vehicle was verified indirectly by concentration control or homogeneity analysis. The samples taken were stored at room temperature over the maximum duration of the administration period and were subsequently deep-frozen. Afterwards these samples were sent to the sponsor.
CLASS METHOD
- Rationale for the selection of the starting dose: By request of the sponsor a starting dose of 2000 mg/kg bw was chosen in the first step
with 3 female animals.
Because no mortality occurred, 2000 mg/kg bw were applied to another group of 3 female animals in the second step. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
• Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
• Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each
workday for the individual animals.
• Mortality: A check for any dead or moribund animals was made at least once each workday.
• Pathology: Necropsy with gross-pathology examination on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with increasing concentrations over time.
• Histology: No histological examinations were performed.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed.
- Mortality:
- No mortality occurred.
- Clinical signs:
- 2000 mg/kg bw (first test group):
- Impaired general state, dyspnoea and piloerection in all animals from hour 0 or hour 1 up to hour 3 and on day 1 after administration.
2000 mg/kg bw (second test group):
- Impaired general state and piloerection were observed in one out of three animals from hour 1 up to hour 5 and on day 1 after administration, whereas dyspnoea was noted from hour 1 up to hour 5 after administration in this animal.
- The other two animals showed piloerection and impaired general state on day 1 after administration only. - Body weight:
- The mean body weight of all animals increased within the normal range throughout the study period.
Mean body weight at study day (g) first test group/ second test group:
day 0: 186.7 ± 4.04 / day 0: 179.3 ± 0.58
day 7: 220.3 ± 6.66 / day 0: 197.3 ± 3.00
day 14: 229.3 ± 6.11 / day 0: 208.3 ± 1.53 - Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
- Other findings:
- No other findings.
Any other information on results incl. tables
Table 1 Acute oral toxicity.
Dose [mg/kg bw] |
Mortality |
Clinical signs |
|
|
N* |
% |
after administration |
Females |
|
|
|
1stadministration |
|
|
|
2000 |
0/3 |
0 |
Hour 0 – day 1 |
|
|
|
|
2ndadministration |
|
|
|
2000 |
0/3 |
0 |
Hour 1 – day 1 |
*N= number of dead animals / number of animals used
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.