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EC number: 618-460-1 | CAS number: 9010-89-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD guideline 423 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]
- EC Number:
- 618-460-1
- Cas Number:
- 9010-89-3
- Molecular formula:
- (C6 H10 O4 . C4 H10 O3)x
- IUPAC Name:
- Hexanedioic acid oligomeric reaction products with 2,2'-oxybis[ethanol]
- Reference substance name:
- Polyesterol 90212
- IUPAC Name:
- Polyesterol 90212
- Test material form:
- other: liquid
- Details on test material:
- Test substance:
colorless clear liquid
Homogeneity: The test item was homogeneous by visual inspection. Additionally homogeneity of the test item was ensured by shaking the test item container.
Storage stability: 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 conditions: Room temperature; avoid temperature < 0°C
Density: 1.072
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test species/strain:
Wistar /Crl:WI(HAN) SPF
Supplier:
Charles River Wiga GmbH, Germany
Age on day 0:
young adult females (approx. 10 weeks)
Sex:
As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
Arrival in the testing facility:
Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Body weight on day 0: Animals of comparable weight (± 20% of the mean weight)
Room temperature/relative humidity:
22+/-3°C, 30-70%
Air changes per hour:
approx. 10
Day/night rhythm: 12/12 h (6 a.m. - 6 p.m./6 p.m.-6 a.m.)
Type of cage:
Makrolon, type II, single housing
Diet:
Feed: VRF1(P) (SDS Special Diets Services, 67122 Altrip, Germany), tap water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ROUTE OF ADMINISTRATION:
Single oral administration by gavage
ADMINISTRATION VOLUME:
1.87 mg/kg bw
FASTING PERIOD:
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
TIME OF DAY OF ADMINISTRATION:
In the morning - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 in first step, another 3 in second step.
- Control animals:
- no
- Details on study design:
- SELECTION OF DOSES/CONCENTRATIONS:
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 administered to another group of 3 female animals in the second step.
OBSERVATION PERIOD:
14 days
BODY WEIGHT DETERMINATION:
Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
CLINICAL OBSERVATIONS:
Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
MORTALITY:
A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
PATHOLOGY:
Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
HISTOLOGY:
No histological examinations were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Clinical signs in the first 2000 mg/kg test group revealed impaired general state and piloerection at hour 1 in one animal or from hour 1 until hour 2 in two animals after administration. No clinical signs were observed in the second 2000 mg/kg test group
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (six females).
Any other information on results incl. tables
Table 1. Individual body weight changes.
Individual body weight changes |
||||||||||
Dose (mg/kg bw): |
2000 |
2000 |
||||||||
Administration: |
1 |
2 |
||||||||
AnimalNo.: |
R604 |
R605 |
R606 |
Mean weight |
Standard deviation |
R632 |
R633 |
R634 |
Mean weight |
Standard deviation |
Body weight at study day (g): |
|
|
|
|
|
|
|
|
|
|
0 |
189 |
187 |
182 |
186.0 |
3.61 |
191 |
193 |
192 |
192.0 |
1.00 |
7 |
206 |
207 |
193 |
202.0 |
7.81 |
202 |
206 |
213 |
207.0 |
5.57 |
14 |
206 |
207 |
191 |
201.3 |
8.96 |
208 |
210 |
223 |
213.7 |
8.14 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the median lethal dose of Polyesterol 90212 after oral administration was found to be greater than 2000 mg/kg bw in rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the undiluted test item Polyesterol 90212 were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females).
The following test substance-related clinical observations were recorded, clinical signs occurred within the first 2 hours after administration:
2000 mg/kg (first test group):
- Impaired general state in all animals
- Piloerection in all animals
- No mortality occurred
2000 mg/kg (second test group):
- No clinical signs
- No mortality occurred
There were no macroscopic pathological findings in all surviving animals sacrificed at the end of the observation period. The mean body weight of two out of six animals increased within the normal range throughout the study period. In three females (two females of the first and one female of the second test group) body weights were within the normal range during the first week, but the animals revealed a stagnation of body weights during the second week. In one female of the first test group the body weight was within the normal range during the first week, but the animal revealed a marginal loss of body weight during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. However, the known effect of slow growth cannot be attributed to the single animal, which showed marginal weight reduction, when compared to the weights of the other females. Nevertheless, the observed marginal weight reduction is considered to be unspecific, as the affected animal did not show any symptoms or change in behavior during the second week.
The acute oral LD50 was calculated to be > 2000 mg/kg bw.
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