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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-11-06 to 2013-11-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP-Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/22: “Acute skin irritation/corrosion study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bureau for chemical substances (Registration No. B/2012/DPL
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:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- 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: contains 9.07% of Mn+2 (content 56.7% of MnIDHA, 40% of Na2SO4, and 3% of H2O (humidity))
- Lot/batch No.: 6/13, date of production: June, 2013
- Expiration date of the lot/batch: June, 2016
- Storage condition of test material: at temperature between 0 – 30°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Department of National Research Institute of Animal Production, Balice near Kraków
- Age at study initiation: 6-month-old – rabbit No. 1 and 6.5-month-old – rabbit No. 2, and on one 9-month-old female – rabbit No. 3
- Housing: individually in metal cages (60 x 35 x 40 cm (length x width x height)). Each cage was equipped with a label containing the number of the study protocol, the dates of the experiment commencement and termination, and sex and number of the animal.
- Diet (e.g. ad libitum): ad libitum; standard granulated "LSK" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22;
- Humidity (%): 45 – 65
- Air changes (per hr): about 16 times/h
- Photoperiod (hrs dark / hrs light): 12 / 12
Start of the study: 04.11.2013
Start of the experimental phase: 06.11.2013
End of the experimental phase: 11.11.2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g (powdered test item)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after the end of the exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze patches were covered with PCV foil and fixed using a non-irritating sticking plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using water
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- During the reading which took place 1 hour after the end of the exposure, no pathological changes on the treated skin of rabbit No. 1 were stated. Very slight (barely perceptible) erythema was stated in rabbit No. 2 and 3.
During the reading which took place 24 hours after the end of the exposure, no pathological changes were stated in rabbits No. 1 and 2. Very slight (barely perceptible) erythema was still observed in rabbit No. 3.
During the reading which took place 48 and 72 hours after the end of the exposure, no pathological changes on the treated skin of the rabbits were stated.
Any other information on results incl. tables
Table 1: Summary of results:
Administered volume of test item | 0.5 mL | ||
Number of rabbit | 1 | 2 | 3 |
Sex | male | male | female |
Mortality of animals | 0/1 | 0/1 | 0/1 |
General clinical signs | none | none | none |
Skin erythema in the treatment area | none | very slight (barely perceptible) after 1 hour | very slight (barely perceptible) after 1 hour and 24 hours |
Skin oedema in the treatment area | none | none | none |
Other | none | none | none |
Body weight of the animals
At the start of the experiment, animal No. 1 weighed 3.3 kg, animal No. 2 weighed 3.6 kg and animal No. 3 weighed 4.3 kg. On the last day of the experiment, animal No. 1 weighed 3.4 kg, animal No. 2 weighed 3.7 kg and animal No. 3 weighed 4.3 kg.
Interpretation of the study results
On the grounds of the study, the test item, i.e. Mn (II) IDHA can be classified to the following categories:
- does not irritate the rabbit skin – according to the Annex to the Decree of the Minister of Health of August 10, 2012 on classification of chemical substances and mixtures (Journal of Laws, item 1018),
- is beyond categorization – according to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling, and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006.
The detailed results of the study based on the scoring system presented in the OECD Guideline No. 404 / EU Method B.4. are given in Table 2.
Table 2 - Point evaluation of acute skin irritation/corrosion on rabbits | ||||||
Acute skin irritation/corrosion on rabbits | ||||||
Cu (II) IDHA | ||||||
Animal No | Observation type | Evaluation after | Average after24, 48and72hours | |||
1hour | 24hours | 48hours | 72hours | |||
1 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
2 | erythema | 1 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
3 | erythema | 1 | 1 | 0 | 0 | 0.3 |
oedema | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The observations of the treated skin revealed some changes in the form of barely perceptible erythema. The test item Mn (II) IDHA does not irritate skin of rabbits.
- Executive summary:
A study was undertaken to investigate the skin irritation potential of Mn (II) IDHA in New Zealand White rabbits (OECD 404; Sornat, 2013, Report No. DDR-15/13). The study commenced with a sighting study on one animal. The powdered test item was applied in an amount of 0.5 g once to the shaved skin of one animal (rabbit No. 1) and covered with an appropriate band. The exposure lasted 4 hours. After evaluation of treated skin, in order to confirm irritation or its absence, the test item was applied to the skin of the next two animals (rabbit No. 2 and No. 3) for 4 hours in order to confirm its irritant properties. The procedure was the same as in case of rabbit No. 1. General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48, and 72 hours after the end of the exposure. Body weights of the animals were determined on the administration day (day 0), i.e. directly before the administration, and on the last day of the experiment. After the observation period, the animals were euthanized.
The observations of the treated skin revealed some changes in the form of barely perceptible erythema.
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