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EC number: 614-587-1 | CAS number: 68551-92-8
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-15 until 2012-06-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP 14 day dose range finding study for the subsequent Reproduction/Developmental Toxicity Screening Test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 14 day dose range finder
- GLP compliance:
- not specified
- Remarks:
- , however the principles of GLP were followed and all data were recorded and retained
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers, ethoxylated
- EC Number:
- 614-587-1
- Cas Number:
- 68551-92-8
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers, ethoxylated
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rat, RccHanTM: WIST(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, B.V., Kreuzelweg 53, 5961 NM Horst / Netherlands
- Age at study initiation: 11 weeks
- Weight at study initiation: Male animals: 369 - 397 g; Female animals: 172 - 227 g
- Fasting period before study: no
- Housing: before randomisation: 3 or 4 animals sex/cage in Makrolon Type IV cages; after randomisation individually in Makrolon Type III cages
- Diet: Pelleted standard Harlan Teklad 2018C (batch no. 80/11) rodent maintenance diet (Provimi Kliba SA, 4303 Kaiseraugst / Switzerland) was available ad libitum.
- Water: Community tap-water from Füllinsdorf was available
ad libitum in water bottles
- Acclimatisation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The dose formulations were prepared daily using the test item as supplied by the Sponsor.
The test item was weighed into a glass beaker on a tared precision balance and approximately 80% of the vehicle was added (w/v). Using an appropriate homogenizer, a homogeneous suspension was prepared. Having obtained a homogeneous mixture, the remaining vehicle was added. Separate formulations were prepared for each concentration. Homogeneity of the test item in the vehicle was maintained during the daily administration period using a magnetic stirrer.
The test item was formulated in the vehicle in concentrations of 0, 75 mg/mL, and 250 mg/mL. A constant treatment volume of 4 mL dose preparation/kg body weight was administered in all groups - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- On the first treatment day samples from the control group as well as three samples (top, middle and bottom) of about 2 g of each concentration were taken prior to dosing for analysis of concentration and homogeneity. Samples of about 2 g of each concentration were taken from the middle to confirm the stability (8 days at room temperature (20 ± 5 °C)). The aliquots for analysis of dose formulations were frozen (-20 ± 5 °C) and delivered on dry ice to analysis laboratory.
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 300 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 4
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- During the first 3 days of treatment, test item was administered by gavage. However, as a consequence of the unplanned deaths, microlabs were used from the fourth day of treatment onwards for application.
At the scheduled necropsy on day 15, animals were sacrificed by an injection of sodium pentobarbital. - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- The following data were recorded on-line: clinical signs and observations, food consumption, body weights, necropsy findings and organ weights (TOX CONTROL).
Viability / Mortality: Twice daily
Clinical Signs: Daily cage-side clinical observations (once daily during pre-treatment period, 3 times on first day of treatment, twice thereafter up to day of necropsy).
Food Consumption: Recorded for the following periods: during pretreatment period days 1 - 7; during the treatment period days 1 - 7 and 7 - 14.
Body Weights: Recorded for the following periods: once during pretreatment period; daily during treatment period.
Hematology
Erythrocyte count
Hemoglobin
Hematocrit
Mean corpuscular volume
Red cell volume distribution width
Mean corpuscular hemoglobin
Mean corpuscular hemoglobin concentration
Hemoglobin concentration distribution width
Leukocyte count, total
Differential leukocyte count:
Platelet count
Reticulocytes
Coagulation
Prothrombin time (= Thromboplastin time)
Activated partial Thromboplastin time
Clinical Biochemistry
Glucose
Urea
Creatinine
Bilirubin, total
Cholesterol, total
Triglycerides
Aspartate aminotransferase
Alanine aminotransferase
Alkaline phosphatase
Gamma-glutamyl-transferase
Bile acids
Sodium
Potassium
Chloride
Calcium
Phosphorus
Protein, total
Albumin
Globulin
Albumin/Globulin ratio - Sacrifice and pathology:
- At the scheduled necropsy on day 15, animals were sacrificed by an injection of sodium pentobarbital.
Necropsy
Any animal sacrificed or found dead during the study was weighed and subjected to macroscopic examination of all internal organs.
When considered appropriate, macroscopic changes in the animals were photographed and samples of tissue fixed in neutral phosphate buffered 4% formaldehyde solution for possible microscopic examination.
Organ Weights
From all animals following organs were trimmed from any adherent tissue, as appropriate, and their wet weight taken:
Adrenal glands (weighed as pairs)
Kidneys (weighed as pairs)
Liver
Spleen - Other examinations:
- None
- Statistics:
- The following statistical methods were used to analyze food consumption, body weights, necropsy findings and organ weight:
• Means and standard deviations of various data were calculated.
• The Dunnett-test (many to one t-test) based on a pooled variance
estimate was applied if the variables could be assumed to follow a normal distribution
for the comparison of the treated groups and the control groups for each sex.
• The Steel-test (many-one rank test) was applied instead of the
Dunnett-test when the data could not be assumed to follow a normal distribution.
• Fisher's exact-test was applied if the variables could be
dichotomized without loss of information.
Results and discussion
Results of examinations
- Details on results:
- Analysis of Dose Formulations
Fatty acids, C18-unsatd. application formulations investigated during the study were found to comprise the test item in the range of 80.9% to 92.2%. All samples met the required content limit of ±20% with reference to the nominal concentration. The homogeneous distribution of Fatty acids, C18-unsatd. in the formulation was approved because single results did not deviate by more than 7.1% (<15%) from the corresponding mean. The application formulations were found to be not stable when stored for eight days at room temperature (20 ± 5 °C). Maximum variation from time zero (homogeneity) mean was 15.5% and therefore not within the required limit of 10%.
Viability / Mortality
There were no test-item related deaths.
Two males in the control group and at 300 mg/kg bw/day, respectively, two females at 100 mg/kg bw/day and one female at 300 mg/kg bw/day died due to an intubation error. One male at 300 mg/kg bw/day and one female at 100 and 300 mg/kg bw/day, respectively, were added to the study as a consequence of those deaths to add to the number of animals per group that achieve a 14-day treatment.
Clinical Signs or Observations
No test item-related clinical signs were noted during the whole course of the study. Clinical signs in the surviving animals were limited to slightly decreased spontaneous activity in one male of group 3 (1000 mg/kg) on the first day of treatment.
Food Consumption
There were no differences in mean food consumption between control animals and animals treated with Fatty acids, C18-unsatd.
Body Weights
There were no differences in mean body weights and mean body weight gain between control animals and animals treated with Fatty acids, C18-unsatd.
Clinical Laboratory Investigations
Hematology
At 1000 mg/kg bw/day in males, the level of platelets was statistically significantly higher and in females statistically significantly lower than in the control group. The value for males was in the range of the historical control data (802 - 1260 G/L) but not for females (924 - 1695 G/L).
Nevertheless, these opposite results were considered to be incidental. No other findings were noted during assessment of the hematology data.
Clinical Biochemistry
No test-item related changes were noted in clinical biochemistry parameters. At 1000 mg/kg bw/day in males, the level of alanine aminotransferase was statistically significantly higher than in the control group. This value was in the range of the historical control data (33.3 - 77.3 U/L) and therefore not test item-related.
Organ Weights
No effects on organ weights were noted for males.
For males at 1000 mg/kg bw/day, absolute and relative (to body weight) liver weights were statistically significantly increased.
For females, organ weights were similar between dose groups and controls.
Macroscopical Findings
No test item-related macroscopical findings were noted at any dose level.
One male at 1000 mg/kg bw/day showed a pelvic dilation of the kidneys and one female at 300mg/kg bw/day dilation with watery fluid of both uterus horns and a nodule in the cervix.
Furthermore, the same animal had a firm dark red and yellowish nodule of the adipose tissue in the body cavity. Of the five animals that died as a consequence of intubation error during the first 3 days of treatment, two showed incompletely collapsed lungs with a dark red discoloration.
Effect levels
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: 14 day dose range finding study oral
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
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