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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2013-10-01 to 2013-10-16
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/21: „Acute dermal toxicity study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bureau of Chemical Substances
- Test type:
- standard acute method
- Limit test:
- yes
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: powdered
- 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: content 56.7% of MnIDHA, 40% of Na2SO4, and 3% of H2O (humidity)
- Lot/batch No.: 7/13, 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:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: husbandry of laboratory animals of the Experimental Medicine Centre at the Medical University in Białystok kept behind the breeding barrier (number in the register of units entitled to the husbandry of laboratory animals: 0043).
- Age at study initiation: 8 weeks old
- Weight at study initiation: 282.8 g (males) and 211.4 g (females)
- Fasting period before study: none
- Housing: in plastic cages covered with wi re bar lids. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height). After the application of the test item, each animal was housed individually. After the removal of the test item from the animals’ skin, there were five rats per cage. Each sex was kept separately. UV-sterilized wood shavings were used as bedding. Each cage was equipped with a label containing the study code, the dose, the dates of the commencement and the expected termination of the experiment, and the animals’ sex and numbers
- Diet (e.g. ad libitum): ad libitum to “Murigran” standard granulated fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C;
- Humidity (%): 35 – 58 %
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ca. 41 cm² (males) ca. 31 cm² (females)
- Type of wrap if used: gauze patches were covered with PCV foil and elastic bandage was used to make circular protecting band
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hours after application of chemical and immediately after removal of the gauze patch
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used:no
- For solids, paste formed: no (The test item was ground, applied to gauze patches, and moistened with a few drops of water. Then, the patches were laid on the prepared skin.)
VEHICLE
- Amount(s) applied (volume or weight with unit): a few drops of water were applied to the ground test item, which was applied to gauze patches - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General and detailed clinical observations of all animals were performed daily during the entire experiment. Body weights of the animals were determined on days 0 (di rectly before the application of the test item), 7, and 14. After the 14-day observation period, the animals were euthanized, dissected, and subjected to detailed gross examinations.
- Other examinations performed: clinical signs, body weight, gross necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the experiment.
- Clinical signs:
- other: no general signs of toxicity were stated in the animals. No pathological skin changes in the site of the test item application were noticed in all males and three females (no. 2, 4, and 5). Skin dryness was stated in two females (no.1 and 3).Moreover, sca
- Gross pathology:
- Gross examinations did not reveal any pathological changes in the examined animals.
- Other findings:
- no other findings reported
Any other information on results incl. tables
Following single application of the test item, the animals did not exhibit any general clinical signs. No pathological skin changes in the site of the test item application were noticed in all males and three females (no. 2, 4, and 5). Skin dryness was stated in two females (no. 1 and 3). Moreover, scabs were stated in one female (no. 3). All animals survived the experiment. During the 14-day experiment, body weight gain was stated in all animals. Gross examinations did not reveal any pathological changes in the examined animals.
Table 1: Summary of results
Mn (II) IDHA: acute dermal toxicity study on rats | ||
Dose of test item(mg/kg b.w.) | 2000 | |
Sex | males | females |
Mortality | 0/5 | 0/5 |
Clinical signs | no changes | no changes were stated (no 2, 4, and 5) |
skin dryness was stated (no 1 and 3) | ||
scabs were stated (no. 3) | ||
Clinical signs
Following single application of the test item, the animals did not exhibit any general clinical signs. No pathological skin changes in the site of the test item application were noticed in all males and three females (no. 2, 4, and 5). Skin dryness was stated in two females (no. 1 and 3) between the 2nd and the 3rd day after the application. Moreover, scabs were stated in one female (no. 3) between the 2nd and the 3rd day after the application. All animals survived the experiment. An overall list of the results of the clinical observations is presented in Table 2.
Table 2 - Clinical signs - overall list | ||||||||
Mn (II) IDHA: acute dermal toxicity study on rats | ||||||||
Dose (mg/kg b.w.) | Sex | Day after application | Number of living animals | Rat number | ||||
1 | 2 | 3 | 4 | 5 | ||||
2000 | males | 0 | 5 | NC | NC | NC | NC | NC |
1 | 5 | NC | NC | NC | NC | NC | ||
2 | 5 | NC | NC | NC | NC | NC | ||
3 | 5 | NC | NC | NC | NC | NC | ||
4 | 5 | NC | NC | NC | NC | NC | ||
5 | 5 | NC | NC | NC | NC | NC | ||
6 | 5 | NC | NC | NC | NC | NC | ||
7 | 5 | NC | NC | NC | NC | NC | ||
8 | 5 | NC | NC | NC | NC | NC | ||
9 | 5 | NC | NC | NC | NC | NC | ||
10 | 5 | NC | NC | NC | NC | NC | ||
11 | 5 | NC | NC | NC | NC | NC | ||
12 | 5 | NC | NC | NC | NC | NC | ||
13 | 5 | NC | NC | NC | NC | NC | ||
14 | 5 | NC | NC | NC | NC | NC | ||
females | 0 | 5 | NC | NC | NC | NC | NC | |
1 | 5 | NC | NC | NC | NC | NC | ||
2 | 5 | SIGNS | NC | SIGNS | NC | NC | ||
3 | 5 | SIGNS | NC | SIGNS | NC | NC | ||
4 | 5 | NC | NC | NC | NC | NC | ||
5 | 5 | NC | NC | NC | NC | NC | ||
6 | 5 | NC | NC | NC | NC | NC | ||
7 | 5 | NC | NC | NC | NC | NC | ||
8 | 5 | NC | NC | NC | NC | NC | ||
9 | 5 | NC | NC | NC | NC | NC | ||
10 | 5 | NC | NC | NC | NC | NC | ||
11 | 5 | NC | NC | NC | NC | NC | ||
12 | 5 | NC | NC | NC | NC | NC | ||
13 | 5 | NC | NC | NC | NC | NC | ||
14 | 5 | NC | NC | NC | NC | NC | ||
NC - no changes | ||||||||
SIGNS - clinical signs |
Body weights of the animals
During the 14-day experiment, body weight gain was stated in all animals. The individual results of body weight measurements are presented in Table 3
Table 3- Bodyweight of animals (g)-overall list | ||||||
Mn(II)IDHA:acute dermal toxicity study on rats | ||||||
Dose(mg/kgb.w.) | Sex | Rat No | Day of experiment/Body weight(g) | Body weight gain(g)(0-14) | ||
0 | 7 | 14 | ||||
2000 | males | 1 | 298 | 330 | 362 | 64 |
2 | 285 | 305 | 326 | 41 | ||
3 | 300 | 325 | 361 | 61 | ||
4 | 243 | 262 | 280 | 37 | ||
5 | 288 | 301 | 322 | 34 | ||
females | 1 | 203 | 220 | 230 | 27 | |
2 | 215 | 229 | 245 | 30 | ||
3 | 208 | 223 | 231 | 23 | ||
4 | 211 | 223 | 233 | 22 | ||
5 | 220 | 237 | 252 | 32 |
Gross examinations
The gross examinations did not reveal any pathological changes in the examined animals.
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 the dermal toxicity potential of Mn (II) IDHA in rats (Kropidlo, A., 2013). Following single application of the test item, the animals did not exhibit any general clinical signs. No pathological skin changes on the site of the test item application were noticed in all males and three females (no. 2, 4, and 5). Skin dryness was stated in two females (no. 1 and 3). Moreover, scabs were stated in one female (no. 3). All animals survived the experiment. During the 14-day experiment, body weight gain was stated in all animals. Gross examinations did not reveal any pathological changes in the examined animals. 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.
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