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EC number: 236-308-9 | CAS number: 13291-61-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 - 03. 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- trans-cyclohexane-1,2-dinitrilotetraacetic acid
- EC Number:
- 236-308-9
- EC Name:
- trans-cyclohexane-1,2-dinitrilotetraacetic acid
- Cas Number:
- 13291-61-7
- Molecular formula:
- C14H22N2O8
- IUPAC Name:
- 2,2',2'',2'''-(cyclohexane-1,2-diyldinitrilo)tetraacetic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Purity: > 99 %
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Age at order : 6-7 weeks old
Weight range at arrival : 158.4-161.3 grams (The body weight of each individual was within 20% of the group’s mean)
Acclimatisation period : At least 5 days
Veterinary health check : During acclimatisation period
Animals per cage 3 during the study: up to 5 during acclimatisation
Housing : Polisulfone solid bottomed cages measuring 59.5×38×20 cm with nesting material provided into suitable bedding bags
Cage control : Daily inspected and changed as necessary (at least 3 times/week)
Water : Drinking water supplied to each cage via a water bottle
Water supply : ad libitum
Diet : 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
Diet supply : ad libitum throughout the study except for the dosing procedure
Room lighting : Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
Air changes : Approximately 15 to 20 air changes per hour
Temperature range : 22°C±2°C
Relative humidity range : 55%±15%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous solution of carboxymethylcellulose
- Details on oral exposure:
- Test item was administered, by gavage, at a dose volume of 10mL/kg using a plastic feeding tube attached to a graded syringe.
- Doses:
- On the day of dosing (Day 1), the amount of the formulated test item to be administered was calculated for each fasted animal according to body weight. Animals were dosed once only on Day 1.
- No. of animals per sex per dose:
- 3 female animals/group
- Details on study design:
- Food was removed fromthe cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
Animals were observed for clinical signs as indicated below:
– Day of dosing
· Session 1: on dosing
· Session 2: approximately 0.5 hour after dosing
· Session 3: approximately 2 hours after dosing
· Session 4: approximately 4 hours after dosing
– Daily thereafter for a total of 14 days (Session 1).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- other: acute toxicity estimate (ATE)
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- A first group of 3 female animals was initially dosed at 300mg/kg (Group 1, Step 1). No mortality occurred and no clinical signs were observed. A second group of 3 female animals was then dosed at the same dose level (Group 2, Step 2). No death occurred and no clinical signs were noted. A third group, similarly composed, was dosed at 2000mg/kg (Group 3, Step 3). No death occurred and no clinical signs were seen. A fourth group of 3 female
animals was administered at the same dose level (Group 4, Step 4). No mortality occurred and no clinical signs were observed. - Body weight:
- Changes in body weight observed during the study were within the expected range for this strain and age of animals.
- Other findings:
- No abnormalities were observed at necropsy examination performed on all animals dosed at 300 and 2000mg/kg (Groups 1, 2, 3 and 4) at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute toxicity of CDTA HHQ was investigated following a single oral administration (10mL/kg in 0.5% aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period. No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000mg/kg.These results indicate that the test item CDTA HHQ did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification : No category
Signal word : No signal word required
Hazard statement : No hazard statement required
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