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EC number: 285-132-9 | CAS number: 85030-08-6
- 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:
- 20 February 2017 - 16 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dodecanedioic acid, compound with 2,2',2''-nitrilotriethanol
- EC Number:
- 285-271-5
- EC Name:
- Dodecanedioic acid, compound with 2,2',2''-nitrilotriethanol
- Cas Number:
- 85049-97-4
- Molecular formula:
- C12H22O4.xC6H15NO3
- IUPAC Name:
- dodecanedioic acid - 2,2',2''-nitrilotriethanol (1:1)
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Test material form:
- solid
- Remarks:
- paste
- Details on test material:
- Name as cited in report: DDDA TEA salt
Physical appearance: beige to pale yellow paste
Storage conditions: at room temperature
Constituent 1
1
- Specific details on test material used for the study:
- - Correction factor: 1.25 based on the manufacturing water content
- Stability at higher temperatures: not stable; maximum temperature is 25°C
- Solubility in vehicle (water): partially
- Stability in vehicle (water): stable
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Animals: 6 young adult females (nulliparous and non-pregnant) of approximately 9 weeks old
- Weight at study initiation: 170-185 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
- Housing: up to 5 animals of the same sex and same dosing group were housed together in in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material equipped with water bottles. For psychological/environmental enrichment, animals were provided with paper, except when interrupted by study prcedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water: municipal tap-water was available ad libitum.
- Acclimation period: at least 5 days before the commencement of dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 10 to 21°C
- Humidity (%): 40-50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 February 2017 - 16 March 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Justification for choice of vehicle: Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure. The vehicle is accepted by international guidelines.
- A single dose of test item was administered to the appropriate animals by oral gavage on Day 1, using a syringe with a plastic gavage cannula attached. The dosing formulations were stirred continuously during dose administration.
- Justifiction for dose level: the dose level was based on the OECD guidelines. - Doses:
- 2000 mg test item (10 mL) /kg bodyweight
- No. of animals per sex per dose:
- 3 females/group
- Control animals:
- no
- Details on study design:
- - Method: The test was performed in a stepwise treatment of 3 females, starting with a dose level of 2000 mg/kg bw. Based on the results, an additional group was dosed at 2000 mg/kg bw.
- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality and moribundity: twice daily
Weighing: individually on day 1, day 8 and day 15.
Other examinations: at least three times on the day of dosing and once daily thereafter.
- Necropsy: yes, all moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded. - Statistics:
- No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- Hunched posture, piloerection, quick breathing, ptosis and/or chromodacryorrhoea (snout) were noted for all animals on Days 1 and/or 2.
- Body weight:
- The mean body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of DDDA TEA salt was established in an acute oral toxicity study in rats (Acute Toxic Class Method), to exceed 2000 mg/kg bw. Based on these results, DDDA TEA salt does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the GHS.
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