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EC number: 217-895-0 | CAS number: 2001-94-7
- 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
Endpoint summary
Administrative data
Description of key information
An acute oral toxicity study has not been conducted on K2EDTA. However,
the acute oral LD50 of edetic acid in rats was found to be 4500 mg/kg bw
(BASF 1973).
K2EDTA is not acutely toxic via the inhalation route. In a OECD 403
guideline compliant acute inhalation study in F344 rats, acute exposure
to K2EDTA for 4hours resulted in an LC50 of >5.80mg/L.
Furthermore it is highly unlikely that K2EDTA would be acutely toxic via
the dermal route as K salts of EDTA are unable to penetrate the skin
with data generated in humans indicating 0.001% of the total dose is
absorbed.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles (non-GLP)
- Justification for type of information:
- Read across is based on a structurally similar material. An analogue justification is attached in section 13 of dataset.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- BASF-TEST: In principle, the methods described in the OECD Guideline 401 were used. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Mean body weight at study initiation: males: 264 g; females: 274 g
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- DOSAGE PREPARATION
- Stock solution prepared: 30%
- Dose volume applied: 10.66 ml/kg bw for the 3200 mg/kg bw dose group; 13.33 ml/kg bw for the 4000 mg/kg bw dose group; 16.66 ml/kg bw for the 5000 mg/kg bw dose group; 21.4 ml/kg bw for the 6400 mg/kg bw dose group; 26.6 ml/kg bw for the 8000 mg/kg bw dose group; 33.3 ml/kg bw for the 10000 mg/kg bw dose group. - Doses:
- 3200; 4000; 5000; 6400; 8000; 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days;
- The animals were observed for mortality and clinical signs of toxicity;
- Frequency of observations: Several times on the application day, thereafter once each working day;
- Body weights were only recorded at the beginning of the study;
- Necropsy of survivors and animals which died performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 500 mg/kg bw
- Mortality:
- 1/10 died in the 3200 mg/kg bw dose group, 3/10 died in the 4000 mg/kg bw dose group, 6/10 died in the 5000 mg/kg bw dose group, 8/10 died in the 6400 mg/kg bw dose group, 9/10 died in the 8000 mg/kg bw dose group, 10/ 10 died in the 10000 mg/kg bw dose group (See table 1).
- Clinical signs:
- other: 3200 mg/kg bw and 4000 mg/kg bw dose group: directly after application accelerated respiration, squatting posture, red eyes; 1 day later: squatting posture, aggressiveness, contaminated fur, slight diarrhea; 5 days later: aggressiveness, contaminated fur;
- Gross pathology:
- Animals which died:
10000 mg/kg bw dose group: heart: acute dilatation, venous hyperemia; kidneys: muddy gray
Remaining dose groups: heart: acute dilatation particularly right, venous hyperemia; stomach: dilatated, dry hard content, bloody ulceration in the corpus; gut: diarrhea,
Animals sacrificed:
-nothing abnormal detected
Reference
Table 1: Mortalities of rats after oral application of EDTA
3200 mg/kg bw | 4000 mg/kg bw | 5000 mg/kg bw | 6400 mg/kg bw | 8000 mg/kg bw | 10000 mg/kg bw | ||
1 h | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | |
24 h | male | 0/5 | 0/5 | 0/5 | 0/5 | 1/5 | 5/5 |
female | 0/5 | 0/5 | 0/5 | 0/5 | 1/5 | 5/5 | |
48 h | male | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 | 5/5 |
female | 0/5 | 0/5 | 0/5 | 1/5 | 1/5 | 5/5 | |
7 d | male | 1/5 | 3/5 | 5/5 | 5/5 | 5/5 | 5/5 |
female | 0/5 | 0/5 | 0/5 | 3/5 | 4/5 | 5/5 | |
14 d | male | 1/5 | 3/5 | 5/5 | 5/5 | 5/5 | 5/5 |
female | 0/5 | 0/5 | 1/5 | 3/5 | 4/5 | 5/5 |
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 4 500 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.8
Additional information
Oral route:
In the key study conducted by BASF AG (1973) single doses of 3200, 4000, 5000, 6400, 8000 and 10000 mg/kg bw edetic acid were administered by gavage to male and females rats as 30% solution in carboxymethyl cellulose solution. The dose groups consisted of 5 males and 5 females each and the animals were observed for 14 days. The LC50 was found to be 4500 mg/kg bw. Clinical symptoms were: squatting posture, aggressiveness, diarrhea and contaminated fur in all dose group. Autopsy of the animals which died revealed acute heart dilatation, bloody ulceration of the stomach and soft to fluid contents of the intestine.
An additional acute oral toxicity study (Akzo Chemicals, 1987) obtained a LD50 > 2000 mg/kg bw for male and female rats. No clinical signs or autopsy findings have been reported up to 2000 mg/kg bw.
Inhalation route:
In the key study conducted by Dow (2016) Groups of five rats/sex were exposed for four hours, using a nose-only inhalation exposure system, to a time-weighted average chamber concentration of 5.80 mg PRIVENTZ™ Liquid per liter of air. The mass median aerodynamic diameter (MMAD) of the PRIVENTZ™ Liquid aerosol present in the exposure chamber test atmosphere averaged 2.17 microns with an average geometric standard deviation of 2.19 microns.
All animals survived the four-hour exposure to the test material as well as the 14-day postexposure period. Clinical effects noted during the four-hour exposure period were limited to soiling of the haircoat in 2/5 male and 3/5 female rats. In-life observations noted postexposure included perineal soiling in 5/5 female rats and extensive body soiling in 2/5 female rats. All rats appeared normal by test day 5. Mean body weight losses of 3.3 and 2.1% were noted for male and female rats, respectively, on test day 2. Pre-exposure mean body weight values were exceeded on test day 8. There were no visible treatment-related lesions noted in any of the rats exposed to PRIVENTZ™ Liquid at the test day 15-scheduled necropsy. Nontreatment related visible lesions noted at necropsy were limited to necrotic fat in one male rat.
Based on these data, the four-hour LC50 of inhaled, aerosolized PRIVENTZ™ Liquid exceeded the limit test concentration of 5 mg/L and is greater than 5.80 mg/L for male and female F344/DuCrl rats.
Justification for classification or non-classification
Based on the results obtained in the toxicity studies and taking into account the provisions laid down in Regulation EC 1272/2008, a classification has not to be done with respect to acute oral, dermal or inhalation toxicity.
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