Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-144-9 | CAS number: 68015-77-0
- 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
The LD50 value in rats was in excess of 2000 mg/kg bw. Other metal chelates did not show inhalation or dermal toxicity. Non-physiological routes of exposure (iv and ip) also showed low acute toxicity.
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
- Study period:
- October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC)
Source: Charles River Deutschland, Sulzfeld, Germany
Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age and body weight: Young adult animals (approx. 8 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Ear- and tailmark
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method: oral gavage, using plastic feeding tubes.
Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
Frequency: Single dosage on Day 1.
Dose level (volume): 2000 mg/kg (3.11 mL/kg) body weight.
Dose volume calculated as (dose level (g/kg) / density (g/mL)) x 2.08 (A correction was made for purity of the test substance (correction factor 2.08)). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded. - Statistics:
- Not needed, limit test
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were noted.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value was in excess of 2000 mg/kg bw.
- Executive summary:
The study was carried out based on the guidelines described in: OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"; Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method"; EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"; JMAFF guidelines (2011) including the most recent partial revisions.
EDTA-MnK2 was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred and no clinical signs were noted. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50value of EDTA-MnK2 in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results, EDTA-MnK2 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011) andRegulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The results of this study together with results of studies with other (metal) chelates provide sufficient data for interpretation.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- April-May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: 269 g (males), 165 g (females)
- Fasting period before study: not applicable
- Housing: groups of 3, in macrolon cages, with bedding of wood shavings and strips of paper
- Diet (e.g. ad libitum): ad lib, except during exposure
- Water (e.g. ad libitum): ad lib, except during exposure
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65 with short excursions to higher levels during cleaning activities
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 April To: 6 May 2010 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: water
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose only inhalation chamber / modification of ADG Developments Ltd.
- Exposure chamber volume: ca. 50 L
- Method of holding animals in test chamber: in polycarbonate restraining tubes
- Source and rate of air: dry compressed air
- Method of conditioning air: test substance was diluted in water; as such compressed air became humidified
- System of generating particulates/aerosols: atomizing a solution of 650 g EDTA-MnNa2 per L water
- Method of particle size determination: 1- stage cascade impactor
- Treatment of exhaust air: filtered
- Temperature, humidity, pressure in air chamber: 23.4 ± 0.2 (23.1-23.6) degrees C; 86 ± 1% (84.9-86.6%); slightly positive pressure in central exposure cylinder; slightly negative pressure in surrounding hood
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric analysis
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable): water
- Concentration of test material in vehicle (if applicable): 650 g/L
- Justification of choice of vehicle: EDTA-MnNa2 is soluble in water; by atomizing a solution in water and evaporation of the water, respirable particles will be generated
- Lot/batch no. (if required): not applicable
- Purity: not applicable
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: measured once before exposure and twice during exposure
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
measurement 1: MMAD = 3.3 µm, GSD = 2.8
measurement 2: MMAD = 3.2 µm, GSD = 2.5
measurement 3: MMAD = 3.3 µm, GSD = 2.4
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: no acute toxicity expected; therefore starting concentration for aerosol used, viz. 5 mg/L. - Analytical verification of test atmosphere concentrations:
- no
- Remarks:
- not needed in case of gravimetry
- Duration of exposure:
- 4 h
- Concentrations:
- 5.16 mg/L
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0 (prior to exposure), days 1, 3, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not needes; single exposure only
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.16 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- None
- Clinical signs:
- other: None during exposure. Shortly after exposure, slight sniffing was heard in one male and 2 females. A slightly soiled fur of the head was observed in all 3 females. No other abnormalities were seen.
- Body weight:
- On days 1 and 3, body weighth gain had slowed down. The overall body weight gain in 14 days was as expected for animals of the strain and age.
- Gross pathology:
- Petechiae were seen on both lobes of the thymus in one male. A petechia aws seen on one lung lobe of one female. These minor abnormalities were not considered to be related to the exposure.
- Other findings:
- None
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Because the 4-h LC50 was > 5.16 mg/L and signs observed during and after exposure were very limited, EDTA-MnNa2 is not toxic after inhalation and classification is not needed.
- Executive summary:
The aim of the present study was to investigate the acute inhalation toxicity of EDTAMnNa2 in rats. Therefore, three male and three female animals were exposed to a target concentration of 5 g/m3 during a single period of four hours. Animals were kept for an observation period of 14 days before sacrifice. To characterize the toxicity, the animals were observed during exposure, shortly after exposure and daily thereafter, body weight was measured before exposure and 1, 3, 7 and 14 days after exposure and the animals were examined for gross pathological changes at necropsy. The actual concentration of the test compound during exposure was 5.16 g/m3, based on gravimetric analysis of the test atmosphere. Measured mass median aerodynamic diameters were 3.2 and 3.3 µm and the distribution of particle sizes had a geometric standard deviation (gsd) of 2.5 and 2.4, respectively. No abnormalities were seen during exposure. Shortly after exposure, however, sniffing was heard in one male and two female animals and a soiled fur of the head was noticed in all three female animals. The next day, these or other clinical abnormalities were no longer seen. Body weight gain was as expected for animals of this age and strain on days 7 and 14, but was decreased on days 1 and 3. The minor macroscopic abnormalities found at necropsy (petechiae on the lobes of the thymus in one male animal and one petechia on one lung lobe in one female animal) were not considered to be related to the exposure. Mortality did not occur during the 14-day observation period after a 4 -hour exposure by inhalation to a concentration of 5.16 g/m3 of EDTA-MnNa2. It is therefore concluded that the 4-hour LC50 is above 5.16 g/m3 for male and female rats. According to the OECD Guideline for Testing of Chemicals 436 EDTA-MnNa2 should be classified as “unclassified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Several studies are available for various metal chelates (see read across document in section 13); no toxicity observed.
Acute toxicity: via dermal route
Endpoint conclusion
- Quality of whole database:
- Studies with two other metal chelates were available both showing LD50 values in excess of 2000 mg/kg bw.
Additional information
The oral route for the endpoint acute toxicity is covered. Several acute inhalation studies with other metal chelates are available (see also read across document in section 13). A third route is not required by Regulation 1907/2006. In addition, the absorption via the skin is expected to be very low (EU RAR, 2004). Acute dermal studies with two other metal chelates showed LD50 values in excess of 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Study in rats, OECD guideline 423
Justification for classification or non-classification
Based on the very low toxicity of EDTA-MnK2 via the oral route, and low inhalation and dermal toxicity observed for other metal chelates (see read across document in section 13) the expected very low dermal absorption, no classification is needed for acute toxicity.
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.