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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is valid without restriction. According to ECHA guidance, a default of 2 is assigned because of read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- version of July 27, 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Dehydrogenated/partially hydrogented gum rosin
- IUPAC Name:
- Dehydrogenated/partially hydrogented gum rosin
- Reference substance name:
- 1740-19-8 (dehydr.) and 65997-06-0 (partially hydro.)
- IUPAC Name:
- 1740-19-8 (dehydr.) and 65997-06-0 (partially hydro.)
- Details on test material:
- - Name of test material (as cited in study report): Dehydrogenated/partially hydrogented gum rosin
- Molecular formula (if other than submission substance):C20H28O2
- Physical state:solid (light yellow to amber)
- Analytical purity: not applicable, substance is UVCB
- Purity test date: Date of Certificate of Analysis not provided in report.
- Lot/batch No.: 6013
- Expiration date of the lot/batch: 16 May 2007
- Stability under test conditions: Stable
- Storage condition of test material: Ambient temperature, in the dark.
- Other: Melting point 90°C, density 1.06 g/cm3
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 7 weeks
- Weight at study initiation: 183g (males) and 125 g (females) with a 20% standard deviation
- Fasting period before study: none
- Housing: 2 or 3 animals of the same sex per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22°C
- Humidity (%): average 60%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 3 2006 To:November 15 2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.1% aqueous solution of Na-carboxymethyl cellulose plus 0.01% Polyoxyethylensorbatanmonooleat
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The vehicle was prepared freshly in biweekly intervals and stored in the refrigerator. The test item formulation was prepared daily prior to dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test item is poorly soluble. The vehicle helped forming a stable suspension.
- Concentration in vehicle: adjusted on body weight
- Amount of vehicle (if gavage): 10 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Determination of stability and homogenity were verified analytically with samples taken on day 8. An HPLC method was used.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 316 and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
(5 additional animals for doses with recovery groups) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Range-finder study
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once a week
BODY WEIGHT: Yes
- Time schedule for examinations:once a week
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 29 and Day 45
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Yes
- How many animals: all
- Parameters examined: Red blood cell count, haemoglobin concentration, haematocrit, mean corpuscular haemoglobin and its concentration, white blood cell count, mean cell volume, platelet count, differential white blood cell count, prothrombin time (Quick)
CLINICAL CHEMISTRY: Yes
- Animals fasted: Yes
- How many animals: all
- Parameters examined: Alanin aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, cholesterol, creatinine, gamma-glutamyltransferase, glucose, potassium, sodium, total protein, urea
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights: adrenal glands, brain, epididymides, heart, liver, kidney, spleen, testes, thymus
HISTOPATHOLOGY: Yes (all gross lesions, adrenal glands, brain, colon, duodenum, heart, iluem , jejunum, kidneys, liver, lungs, lymph nodes (mandibular, mesenteric), ovaries, prostate, sciatic nerve, spinal cord, spleen, sternum with bone marrow, stomach, testes, thymus, thyroid and parathyroid glands, trachea, urinary bladder, uterus) - Statistics:
- Analysis of variance follwed by the Schffe-test, t-test, H-test of Krskal and Wallis followed by the test of Nemenyi, Chi-square test and Fisher`s exact test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- A significant increase in creatinine and sodium was observed in high dosed animals, but the values were within the historical control range. The increase was not observed in animals of the recovery group.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- centrilobular cytoplasmatic vacuolization of hepatocytes of females, still present after the 14-day recovery sacrifice.
- Details on results:
- None of the slight differences in the values for haematology, clinical chemistry and organ weights showed a dose-response relationship and all values were within the range of historical control values.
The test substance was found to be sufficiently stable in preparations for at least 4h. Concentrations and homogenity checks showed that these parameters were within acceptable limits.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 316 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: centrilobular cytoplasmatic vacuolization in hepatocytes, not reversible within 14 days.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
mean clinical biochemistry data, males | ||||||
parameter | control | 100 mg/kg bw | 316 mg/kg bw | 1000 mg/kg bw | recovery control | recovery high dose |
Cholesterol | 1.47 | 1.49 | 1.48 | 1.52 | 1.44 | 1.51 |
AST | 76.2 | 82.4 | 81.2 | 85.6 | 79.8 | 87.8 |
ALT | 60.2 | 63 | 56.4 | 52.8 | 55.6 | 60.4 |
GGT | 0.58 | 0.46 | 0.26 | 0.38 | 0.5 | 0.44 |
AP | 183 | 153 | 202 | 204 | 209 | 166 |
UREA | 7.93 | 7.93 | 8.31 | 7.11 | 8.67 | 9.36 |
CREA | 30.4 | 30.8 | 30.6 | 32.4 | 35.4 | 32.7 |
GLU | 6.43 | 6.75 | 5.55 | 5.91 | 6.11 | 6.81 |
TP | 70 | 71.5 | 71.2 | 71.4 | 72.8 | 73.4 |
ALB | 43.6 | 42.4 | 43.7 | 44.1 | 45.4 | 43.6 |
Na | 140 | 141 | 140 | 140 | 141 | 140 |
K | 3.3 | 3.3 | 3.32 | 3.3 | 3.16 | 3.18 |
mean clinical biochemistry data, females | ||||||
parameter | control | 100 mg/kg bw | 316 mg/kg bw | 1000 mg/kg bw | recovery control | recovery high dose |
Cholesterol | 1.92 | 1.97 | 1.92 | 1.93 | 1.92 | 1.82 |
AST | 88.5 | 84.8 | 85.4 | 89.2 | 93 | 85.8 |
ALT | 52.2 | 57.4 | 50.4 | 51.4 | 60 | 51.8 |
GGT | 0.6 | 0.74 | 0.46 | 0.6 | 0.44 | 0.74 |
AP | 177 | 142 | 178 | 172 | 176 | 157 |
UREA | 7.31 | 7.7 | 7.5 | 7.73 | 8.44 | 7.13 |
CREA | 26.7 | 28.8 | 30.1 | 29 | 33.9 | 29.5 |
GLU | 5.01 | 5.02 | 4.36 | 4.41 | 4.39 | 5 |
TP | 67 | 70.4 | 67.1 | 68 | 69.1 | 67.7 |
ALB | 43.4 | 43.1 | 43.2 | 44.5 | 44.6 | 42.2 |
Na | 138 | 140 | 139 | 140 | 140 | 140 |
K | 3.44 | 3.3 | 3.32 | 3.2 | 3.22 | 3.14 |
Details on the histopathology findings in liver:
One female of the control/recovery group showed minimal cytoplasmatic centrilobular vacuolization of hepatocyes.
Both at the end of dosing and after recovery, in the high dosed females the same was observed with minimal and mild severety in one and three animals, respectively.
No histopathology findings were observed in males.
In the high dosed recovery group females,
Applicant's summary and conclusion
- Conclusions:
- No adverse effects upon subacute oral gavage dosing if rats was observed at 316 mg/kg bw.
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