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EC number: 939-867-3 | CAS number: -
- 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:
- 2006-12-20 to 2007-01-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Statement of GLP Compliance No. G 024 (Slovak National Accreditation Service); Statement of GLP Compliance No. 4/2006/DPL.
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of disodium [2,2'-(imino-kappaN)dibutanedioato-kappa2O1,O4(4-)]manganese(2-) and sodium sulphate
- EC Number:
- 939-867-3
- Cas Number:
- 666748-58-9
- Molecular formula:
- MnC8H7NO8Na2
- IUPAC Name:
- Reaction mass of disodium [2,2'-(imino-kappaN)dibutanedioato-kappa2O1,O4(4-)]manganese(2-) and sodium sulphate
- Reference substance name:
- Manganese chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- IUPAC Name:
- Manganese chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- Reference substance name:
- Mn(II)IDHA
- IUPAC Name:
- Mn(II)IDHA
- Test material form:
- other: water solution
- Details on test material:
- - Name of test material (as cited in study report): Mn(II)IDHA
- Substance type: chelate
- Physical state: solid (odourless, white microgranules)
- Analytical purity:
- Impurities (identity and concentrations):
- Purity test date:
- Lot/batch No.:
- Expiration date: 14.09.209
Data concerning the identification, purity and durability of the analysed material are the responsibility of the Mandator.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: conventional farm of laboratory animals run by the Institute of Occupational Medicine in Łódź, Poland.
- Age at study initiation: Pilot study: 9 week; Main experiment: 11 weeks
- Weight at study initiation: Pilot study: 166 g; Main experiment: average body weight of 190.5 g.
- Fasting period before study: yes. The day before the experiment was due to commence, some 18 hours before administration of the analysed material, the animals were deprived of feed, being left with only water. Feed was made available again 3 hours after administration of the analysed substance.
- Housing: plastic cages with metal wire covers, with the following dimensions (length x width x height): 58 x 37 x 21 cm.
During the experiment, the animals were kept in cages individually (initial study) and in groups of four (study proper). The litter comprised dedusted wood shavings, sterilised with ultraviolet radiation. Each cage was fitted with a signboard containing the study code, the dose applied, the date of commencement and planned termination of the experiment, as well as the sex and individual numbers of animals.
- Diet (e.g. ad libitum): ad libitum (standard granulated "Murigran" laboratory feed, manufactured by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL of Motycz)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 45-71
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
The analysed substance was administered to the rats on the following days: 20.12.2006. (1 female – initial experiment, dose of 2,000 mg/kg of body mass) and 04.01.2007. (4 females – experiment proper, dose of 2,000 mg/kg of body mass). The experiment was terminated on the following days: 03.01.2007 (1 female – initial experiment, dose of 2,000 mg/kg of body mass) and 18.01.2007 (4 females – experiment proper, dose of 2,000 mg/kg of body mass), respectively.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 mL of the water solution of the analysed substance contained: 400 mg of the substance (dose of 2,000 mg/kg b.w.);
- Amount of vehicle (if gavage): 0.5 mL per 100 g of the body weight. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Initial experiment: one animal
Main strudy: four animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: An assessment of the general condition of the animals, i.e. observation of all animals in terms of incidence and mortality, was performed twice daily throughout the 14-day duration of the experiment. Detailed clinical observations were performed on the day of administration of the analysed substance (day 0), 10, 30 and 60 minutes after administration, and subsequently every hour over a period of 5 hours from the time of administration. On successive days of the 14-day period of the experiment – once daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
- Preliminary study:
- Following the single administration of the analysed substance, this in a dose of 2,000 mg/kg of body mass, to one female (initial experiment), no symptoms of toxicity were observed during the 14-day period of observation. The female survived the 14-day period of observation.
Following the single administration of the analysed substance, this in a dose of 2,000 mg/kg of body mass, to four successive females (experiment proper), no symptoms of toxicity were observed during the 14-day period of observation for three of the animals. The females survived the 14-day observation period.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: based on mortality, clinical signs and findings at necropsy at 2000 mg/kg bw
- Mortality:
- All females survived the 14-day observation period.
- Clinical signs:
- other: Following the single administration of the analysed substance, this in a dose of 2,000 mg/kg of body mass, to one female (initial experiment), no symptoms of toxicity were observed during the 14-day period of observation. Following the single administrati
- Gross pathology:
- No pathological changes were found during the macroscopic study in the analysed animals.
Any other information on results incl. tables
Table 1. Mn (II) IDHA Acute oral toxicity study conducted on rats – clinical symptoms – summary breakdown
Dose(mg/kg b.w.) |
Day following administration |
Number of live animals |
Rat no. |
||||
1* |
2 |
3 |
4 |
5 |
|||
2,000 |
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 |
5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 |
BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ |
BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ |
BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ |
BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ |
BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ BZ |
* female from the initial experiment
BZ = without change
Table 2. Mn (II) IDHA Acute oral toxicity study conducted on rats - animal body mass (g)
Dose mg/kg b.w. |
Rat no. |
Day of experiment |
Difference 14 – 0 |
||
0 |
7 |
14 |
|||
2,000 |
1* 2 3 4 5 |
166 183 198 188 193 |
215 210 227 206 228 |
236 219 229 216 232 |
70 36 31 28 39 |
* females from the initial experiment
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the grounds of the study, it may be stated that the median lethal dose (LD50) of Mn (II) IDHA is greater than 2000 mg/kg b.w.
- Executive summary:
A study was conducted to test oral toxicity potential of Mn (II) IDHA in rats. Following the single administration of the analysed substance in a dose of 2,000 mg/kg b.w. to a single female, no symptoms of toxicity were observed during the 14-day period of observation. The female survived the 14-day period of observation. Following the single administration of the analysed substance in a dose of 2,000 mg/kg bw to four successive females, no symptoms of toxicity were observed during the 14-day period of observation. The females survived the 14-day observation period. All the animals were put down following the 14-day period of observation and subsequently underwent autopsies and macroscopic studies. No pathological changes were found during the macroscopic study in the studied animals.
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