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EC number: 200-449-4 | CAS number: 60-00-4
- 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
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Endpoint summary
Administrative data
Description of key information
The acute oral LD50 of edetic acid in rats was found to be 4500 mg/kg bw (BASF SE, 1973). The LOAEC established in an inhalation study with Na2EDTAwas considered to be 30 mg/m³ air. Furthermore, it is highly unlikely that EDTA induced acute dermal toxicity as neither Ca or Na salts of EDTA are able to penetrate the skin.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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
- Specific details on test material used for the study:
- OTHER SPECIFICS:
- Name of test material (as cited in study report): Trilon BS - 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 - Interpretation of results:
- other: Classification criteria of Regulation (EC) No 1272/2008 not met
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
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 412 (Repeated Dose Inhalation Toxicity: 28/14-Day)
- Deviations:
- yes
- Remarks:
- Dosing until day 5 only
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: subacute
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch Number: 06088797V0
OTHER SPECIFICS
- Expiry date: 1 September 2011
- Appearance: Solid white powder - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Age: 7 weeks (approx)
Identification: Tattooing of ears
All animals free of disease and clinical signs
Rats housed together (5 animals per cage) in Polysulfon cages
Bedding: Type Lignocel fibres, dust free bedding
Woodne gnawing blocks for enrichment
Rooms: Fully ariconditioned, temperature range 20 to 24 degrees celcius, 30 to 70% humidity
Light/dark cycle of 12 hours (6 am to 6pm light, 6 pm to 6 am dark)
Food, drinking water and bedding/enrichment materials were analysed for chemical and microbiological contaminants. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- A dust aerosol was generated using a dust generator and compressed air inside a mixing stage mixed with conditioned dilution air and passed into the inhalation system. The test substance was mixed with Aerosil R972 prior to facilitate aerosol generation.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Concentrations of the inhalation atmospheres were analyzed using gravimetry. Daily means were calculated based on 2 measured samples per concentration and exposure.
- Duration of exposure:
- 6 h
- Remarks on duration:
- per day, 5 consecutive days
- Concentrations:
- - 30, 300, 1000 mg/m³ (nominal conc. of Na2H2EDTA)
- 33.3 (± 2.3), 320 (± 27), 1103 (± 52) mg/m3 (measured (with SD) referring to test substance Na2H2EDTA x 2 H2O) - No. of animals per sex per dose:
- 10 animals per dose group
An additional 10 animals for the high dose group and control - Control animals:
- yes
- Details on study design:
- The animals were exposed to a respirable dust aerosol for 6 hours per day for 5 consecutive days. The exception was the high dose group (1000mg/m3) where exposure was for one day only due to mortality observed.
- Statistics:
- Body weight/body weight change, food consumption - comparison of each group with control using DUNNETTS test (two-sided) for the hypothesis of equal means. Clinical pathology, urine volumes, urine specific gravity, weight parameters - non-parametric one-way analysis using Kruskal-wallis test (two sided). If resulting p-value was less than 0.05, a pairwise comparison of each dose group with the control group was performed using Wilcoxon-test (two sided) for equal means.
- Key result
- Sex:
- male
- Dose descriptor:
- other: LOAEC
- Effect level:
- ca. 30 mg/m³ air
- Based on:
- test mat.
- Remarks on result:
- other: Basis for effect level: histopathology of the respiratory tract and lung weights
- Mortality:
- 6 deaths in the high dose group on days 0 and 1. Accelerated respiration, respiration sounds, piloerection, red encrusted nose, hunched position; Mid dose group - accelerated respiration, respiration sounds, piloerection, reduced fur care
- Clinical signs:
- other: 6 deaths in the high dose group on days 0 and 1. Accelerated respiration, respiration sounds, piloerection, red encrusted nose, hunched position; Mid dose group - accelerated respiration, respiration sounds, piloerection, reduced fur care
- Body weight:
- Decreased bodyweight change in mid and high dose group
- Gross pathology:
- Congestion, edema and multifocal hemorraghes in lungs of high dose group
- Other findings:
- FOOD CONSUMPTION
- decreased food consumption between days 0 and 1 in mid and high dose group
ORGAN WEIGHTS
- Lung weight increase in low and mid dose group - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Inhalation exposure to 1000 mg/m3 disodium EDTA for 6 hours caused lethality in 6 out of 20 male rats. Histological examination of the lung of the dead rats revealed congestion, edema, multifocal hemorraghes and inflammatory cell infiltrates. Inhalation exposure of rats to disodium EDTA for 6 hours per day, 5 consecutive days cause concentration dependant lesions inthe larynx and lungs that were fully reversible within 14 days. Due to histopahological changes in the low dose group a no observed effect level could not be determined.
- Executive summary:
In a subacute repeated dose toxicity study (BASF, 2009) 10 male Wistar rats per dose were exposed to a respirable dust aerosol of Na2H2EDTA for 6 hours per day for 5 consecutive days at concentrations of 0, 30, 300, 1000 mg/m³ air (also see capter 7.5).
Exposure in the high dose group (1000 mg/m3) was for one day only due to mortality observed. Inhalation exposure to 1000 mg/m³ disodium EDTA for 6 hours caused lethality in 6 out of 20 male rats. Histological examination of the lung of the dead rats revealed congestion, edema, multifocal hemorraghes and inflammatory cell infiltrates.
Inhalation exposure of rats to disodium EDTA for 6 hours per day, 5 consecutive days caused concentration dependant lesions in the larynx and lungs that were fully reversible within 14 days. Due to histopahological changes in the low dose group a no observed effect level could not be determined.
The LOAEC was considered to be 30 mg/m³ air.
Reference
DETAILS ON RESULTS
Histopathology results:
High dose: Multifocal hemorraghes in the lungs; Inflammatory cell infiltrates
Mid dose:
Larynx: laryngeal, epithelial necrosis, multifocal, in various levels of the larynx
Inflammatory cell infiltrates in various levels of the larynx
laryngeal squamous metaplasia, multifocal, in various levels of the larynx
Regenerative hyperplasia of the laryngeal epithelium, multifocal, in various levels of the larynx
Lungs: Regenerative hyperplasia of bronchiolar epithelium (predominantly: medium bronchi, terminal bronchioles)
Mucous cell hyperplasia in large bronchi
interstitial infiltration of eosinophylic granulocytic cells
Low dose:
Larynx: Laryngeal, epithelial necrosis, multifocal, at the base of the epiglittis (level 1)
Inflammatory cell infiltrates at the base of the epiglottis (level 1)
Lungs: Regenerative hyperplasia of the bronchiolar epithelium (predominantly medium bronchi and terminal bronchioles)
Mucous cell hyperplasia in large bronchi
interstitial infiltration of eosinophylic granulocytic cells.
There were no histopathological findings in any of the recovery group animals. Thus, all pathology was reversible within the recovery period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
ORAL
In the key study (BASF SE, 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
In a subacute repeated dose toxicity study (BASF SE, 2010) 10 male Wistar rats per dose were exposed to a respirable dust aerosol of Na2H2EDTA for 6 hours per day for 5 consecutive days at concentrations of 0, 30, 300, 1000 mg/m³ air (also see chapter 7.5).
Exposure in the high dose group (1000 mg/m³) was for one day only due to mortality observed. Inhalation exposure to 1000 mg/m³ disodium EDTA for 6 hours caused lethality in 6 out of 20 male rats. Histological examination of the lung of the dead rats revealed congestion, edema, multifocal hemorraghes and inflammatory cell infiltrates.
Inhalation exposure of rats to disodium EDTA for 6 hours per day, 5 consecutive days cause concentration dependant lesions in the larynx and lungs that were fully reversible within 14 days. Due to histopahological changes in the low dose group a no observed effect level could not be determined.
The LOAEC was considered to be 30 mg/m³ air.
Justification for classification or non-classification
SELF-CLASSIFICATION ACCORDING TO REGULATION (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result, the substance is considered to be classified as Acute Toxicity Inhalation Cat. 4 (H332, harmful if inhaled) but not classified for acute oral and acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
CLASSIFICATION ACCORDING TO ANNEX VI OF REGULATION (EC) No 1272/2008.
The substance is not officially classified for acute oral, dermal or inhalation toxicity under Regulation (EC) No. 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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