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EC number: 304-038-1 | CAS number: 94233-08-6
- 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:
- From December 12, 2007 to January 04, 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The batch tested is a commercial product
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Cobalt diammonium EDTA
- IUPAC Name:
- Cobalt diammonium EDTA
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 150 to 174 grams
- Fasting period before study: overnight prior to dosing (Day –1) up to 4 hours after
dosing
- Housing: Polycarbonate cages measuring 42.5x26.6x18 cm during study, with stainless steel mesh lid and floor.
- Diet (e.g. ad libitum): 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)) ad libitum
- Water (e.g. ad libitum): drinking water supplied to each cage via a water bottle ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): artificial (fluorescent tubes), daily light/dark cycle of
12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 0.5% acqueous solution of carboxymethylcellulose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and morbidity twice daily, clinical signs in the day of dosing (on dosing, approximately 0.5, 2 and 4 hours after dosing) and daily thereafter (14 days), body weight on allocation (Day-1), Days 1, 2, 8 and 15 or when found
dead.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred in the three female animals initially dosed at 2000 mg/kg.
- Clinical signs:
- Step 1
Piloerection was recorded in all animals on the day of dosing and on Day 2. Additionally, brown staining of the cage tray was recorded on Day 2. Recovery occurred by Day 3.
Step 2
The same clinical signs of step 1 were recorded: piloerection on the day of dosing and on Day 2 and brown staining on the cage tray on Day 2 only. Recovery occurred by Day 3. - Body weight:
- At the end of the observation period, changes in body weight were within the expected range for this strain and age of animals.
- Gross pathology:
- No external or internal abnormalities were observed at necropsy examination performed at the end of the observation period in all the animals dosed at 2000 mg/kg (step 1 and 2).
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method
The acute toxicity of the test item was investigated following a single oral administration (10 ml/kg in 0.5% carboxymethylcellulose in water) to the Sprague Dawley rat (6 female animals/group) followed by a 14-day observation period, according to the OECD guideline 423.
Observations
A first sub-group of 3 female animals was initially dosed at 2000 mg/kg (step 1). No mortality occurred and a second sub-group of animals, similarly composed, was then dosed at the same dose level (step 2) bringing the group size up to 6 animals.
In both steps mortality did not occur and clinical signs were limited to piloerection (Day 1 and 2) and brown staining on the cage tray (Day 2). Recovery occurred by Day 3.
At the end of the observation period, changes in body weight were within the expected range for this strain and age of animals.
The animals were killed at the end of the observation period and all animals were subjected to necropsy examination.
No external or internal abnormalities were observed in all the animals dosed at 2000 mg/kg (step 1 and 2).
Conclusion
The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight.
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