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EC number: 700-772-5 | CAS number: 1190961-28-4
- 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:
- between 20 May 2009 and I0 June 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- Not considered to affect study validity
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- Not considered to affect study validity
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- EC Number:
- 700-772-5
- Cas Number:
- 1190961-28-4
- Molecular formula:
- N/A - too complex
- IUPAC Name:
- 1,6-bis({2,2-bis[(undecyloxy)methyl]butyl}) hexanedioate
- Details on test material:
- - Physical state: Amber liquid
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: 92-93%
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 180-201 g. The bodyweight variation did not exceed 20% of the initial mean bodyweight of any previously dosed animal(s).
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30 – 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Bidistilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/ml and 200 mg/ml
- Amount of vehicle (if gavage): calculated to individual animal fasted bodyweight at time of dosing
- Justification for choice of vehicle: 10 ml/kg
- Lot/batch no. (if required): NDA
- Purity: NDA
- Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- total was 6 females (one animal at 300 mg/kg and five at 2000 mg/kg)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs observed daily, body weights measured on days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight no further details available - Statistics:
- An estimate of the acute oral median lethal dose (LD50) of the substance was made using the mortality data obtained.
Results and discussion
- Preliminary study:
- Asingle female rat was dosed at a level of 300 mg/kg bw.
There was no mortality.
Asingle female rat was dosed at a level of 2000 mg/kg bw.
There was no mortality.
As such, an additional group of 4 animals were dosed at 2000 mg/kg in the main study.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Organ weights: No Data Available
- Histopathology: No Data Available
- Potential target organs: No Data Available
- Other observations:No Data Available
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female RccHan:WIST strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonized Classification System -Unclassified).
- Executive summary:
INTRODUCTION
The study was performed to assess the acute oral toxicity of the test material in the RccHan:WIST strain rat. The method was designed to meet the requirements of the following:
OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity -Fixed Dose Method" (adopted 17 December 2001)
Method B1 Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
METHODS
To determine the dose level for the main study, two sighting studies were conducted with one animal each (female RccHan:WIST (SPF) rat). The two animals were treated sequentially with the test item at the dose levels of 300 or 2000 mg/kg body weight by single oral gavage administration. The test item was formulated in purified water at a concentration of 0.03 g/mL and 0.2 g/mL, respectively and administered at a dose volume of 10 mL/kg. Since no mortality occurred in the animal treated with 2000 mg/kg body weight, additional four females were treated at this dose level in the main study.
The animals were examined daily during the acclimatization period and mortality/viability and clinical signs were recorded. All animals were examined for clinical signs before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2-15. Mortality/viability was recorded before treatment, within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during test days 2-15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and macroscopically examined.
RESULTS
Mortality: There were no deaths.
Clinical Observations: On the day of the treatment, the animal treated with 300 mg/kg body weight showed ruffled fur up to three hours after application. Thereafter no clinical signs were observed. All five animals treated with 2000 mg/kg body weight did not show any clinical signs after treatment.
Body weight: The body weight of the animals was within the range commonly recorded for this strain and age.
Necropsy: No abnormalities were noted at necropsy.
CONCLUSION
The LD50 after single oral administration to female rats, observed over a period of 14 days, is greater than 2000 mg/kg body weight. Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), the test substance is not classified with respect to acute oral toxicity in the rat.
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