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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-11-08 to 2013-11-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/23: “Acute eye irritation/corrosion study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bureau for chemical substances, Registration No. 8/2012/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:
- other: aqueous solution
- Details on test material:
- - Name of test material (as cited in study report): Mn (II) IDHA
- Substance type: chelate
- Physical state: solid (white granules)
- Analytical purity: 9.07 % of Mn+2
- Composition of test material, percentage of components: 56.7% of MnIDHA, 40% of Na2SO4, and 3% of H2O (humidity)
- Purity test date: 2013-07-16
- Lot/batch No.: 7/2013, produced in June 2013; delivered by Sponsor on 8 July, 2013
- Expiration date of the lot/batch: June 2016.
- Stability under test conditions: June 2016.
- Storage condition of test material: at temperature between 0 – 30 °C
- Other: Data concerning the identity, purity, and stability of the test item are the responsibility of the Sponsor
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: the Experimental Department of the National Research Institute of Animal Production, Balice near Kraków.
- Age at study initiation: 8.5-month-old – rabbit No. 1 and 6-mounths-old – rabbit No. 2 and No. 3.
- Weight at study initiation: At the start of the experiment rabbit No. 1 weighed: 4.0 kg, rabbit No. 2 weighted 3.9 kg and rabbit No. 3 weighted 4.1 kg.
- Housing: individually in metal cages with dimensions (length x width x height): 60 x 35 x 40 cm.
- 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: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 45 – 60
- Air changes (per hr): about 16 times/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
Start of the study: 04.11.2013
Start of the experimental phase: 08.11.2013
End of the experimental phase: 16.11.2013
Test system
- Vehicle:
- water
- Controls:
- other: The second eye was used as the control one
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.065 g
- Concentration (if solution):0.065 g/0.1 mL - Duration of treatment / exposure:
- single administration
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration of the test item
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Sixty minutes prior to the test item application, an analgesic, i.e. bunondol at a dose of 0.01 mg/kg b.w. was administered to each animal. Five minutes prior to the test item application, one or two drops of a topical anesthetic alcaine was applied to both eyes. During reading after 1 hour after administration of the test item, no corneal opacity and no lesions of iris in the treated eye were stated and redness and swelling were not more than 2, so the administration of anesthetics was discontinued.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: classification on the basis of OECD Guideline No 405 / EU Method B.5
Cornea
Opacity: degree of density (readings should be taken from most dense area) *
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
Maximum possible: 4
* The area of corneal opacity should be noted
Iris:
- Normal: 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris reactive to light (a sluggish reaction is considered to be an effect): 1
- Hemorrhage, gross destruction, or no reaction to light: 2
Maximum possible: 2
Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
- Normal: 0
- Some blood vessels hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
Maximum possible: 3
Chemosis:
Swelling (refers to lids and/or nictating membranes)
- Normal: 0
- Some swelling above normal: 1
- Obvious swelling, with partial eversion of lids: 2
- Swelling, with lids about half closed: 3
- Swelling, with lids more than half closed: 4
Maximum posible: 4
TOOL USED TO ASSESS SCORE: not reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of readings in animal 1, 2 and 3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of readings in animal 1, 2 and 3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- After the application of the test item, pathological changes in the conjunctivas of the animals’ eyes were stated. No pathological changes in the cornea and iris were stated.
- Other effects:
- No other effects reported.
At the start of the experiment rabbit No. 1 weighed: 4.0 kg, rabbit No. 2 weighted 3.9 kg and rabbit No. 3 weighted 4.1 kg. On the day of experimental end the animals weighed respectively: 4.0 kg, 3.8 kg and 4.1 kg.
Any other information on results incl. tables
Body weight
At the start of the experiment rabbit No. 1 weighed: 4.0 kg, rabbit No. 2 weighted 3.9 kg and rabbit No. 3 weighted 4.1 kg. On the day of experimental end the animals weighed respectively: 4.0 kg, 3.8 kg and 4.1 kg.
Ocular findings
After the application of the test item, pathological changes in the conjunctivas of the animals’ eyes were stated. No pathological changes in the cornea and iris were stated. During the reading which took place 1 hour after the application of the test item, congestion of some blood vessels was stated in rabbit No. 1 and 3, whereas diffuse crimson colour was stated in rabbit No. 2. Congestion of the nictitating membrane, circumcorneal injection, slight swelling of the conjunctiva, and swelling of the nictitating membrane were stated in three rabbits. Furthermore, a small volume of discharge in rabbit No. 1 and 3, and discharge on the lids and lids’ hair in rabbit No. 2 were observed.
During the reading which took place 24 hours after the application of the test item, congestion of some blood vessels was stated in rabbits No. 1 and 3, whereas diffuse, crimson colour was stated in rabbit No. 2. Congestion of the nictitating membrane was stated in three rabbits. Additionally, circumcorneal injection was stated in rabbit No. 1. Slight swelling of the conjunctiva and swelling of the nictitating membrane were still observed in rabbit No. 1. No swelling was stated in rabbits No. 2 and 3. No discharge from the conjunctivae sack was stated in three rabbits. During the reading which took place 48 hours after the application of the test item, congestion of some blood vessels and congestion of the nictitating membrane were stated in rabbit No. 1 and 2. Additionally, circumcorneal injection in rabbit No. 1 was still observed. No pathological changes were stated in rabbit No. 3. During the reading which took place 72 hours after the application of the test item, no pathological changes in the conjunctivas of the rabbits were stated. The detailed results of the clinical observations are presented in Table 1.
Table 1. Detailed results of clinical observations of eye
Animal |
Reading after |
CHANGES IN EYE |
||||
No |
CORNEA |
IRIS |
CONJUNCTIVA |
|||
erythema |
swelling |
other |
||||
1
|
1h |
no changes |
no changes |
injection of some blood vessels; congestion of nictating membrane, circumcorneal injection |
slight swelling; swelling of nictating membrane |
slight volume of discharge |
24h |
no changes |
no changes |
injection of some blood vessels; congestion of nictating membrane; circumcorneal injection |
slight swelling; swelling of nictating membrane |
no changes |
|
48h |
no changes |
no changes |
injection of some blood vessels; congestion of nictating membrane; circumcorneal injection |
no changes |
no changes |
|
72h |
no changes |
no changes |
no changes |
no changes |
no changes |
|
2
|
1h |
no changes |
no changes |
diffuse crimson colour; congestion of nictating membrane; circumcorneal injection |
slight swelling; swelling of nictating membrane |
discharge on lids and lids' hair |
24h |
no changes |
no changes |
diffuse crimson colour; congestion of nictating membrane, |
no changes |
no changes |
|
48h |
no changes |
no changes |
injection of some blood vessels; congestion of nictating membrane |
no changes |
no changes |
|
72h |
no changes |
no changes |
no changes |
no changes |
no changes |
|
3
|
1h |
no changes |
no changes |
injection of some blood vessels, congestion of nictating membrane, circumcorneal injection |
slight swelling; swelling of nictating membrane |
slight volume of discharge |
24h |
no changes |
no changes |
injection of some blood vessels, congestion of nictating membrane |
no changes |
no changes |
|
48h |
no changes |
no changes |
no changes |
no changes |
no changes |
|
72h |
no changes |
no changes |
no changes |
no changes |
no changes |
The point evaluation of acute eye irritation/corrosion based on the scoring system given in the OECD Guideline No 405 / EU Method B.5. is presented in Table 2.
Table 2. Point evaluation of acute eye irritation / corrosion
Rabbit No |
Part of eye |
Reading after |
Average of readings after 24, 48, 72 hours |
||||
1 hour |
24 hours |
48 hours |
72 hours |
||||
1 |
Cornea |
|
0 |
0 |
0 |
0 |
0.0 |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctiva |
erythema |
1 |
1 |
1 |
0 |
0.7 |
|
swelling |
1 |
1 |
0 |
0 |
0.3 |
||
2 |
Cornea |
|
0 |
0 |
0 |
0 |
0.0 |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctiva |
erythema |
2 |
2 |
1 |
0 |
1.0 |
|
swelling |
1 |
0 |
0 |
0 |
0.0 |
||
3 |
Cornea |
|
0 |
0 |
0 |
0 |
0.0 |
Iris |
|
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctiva |
erythema |
1 |
1 |
0 |
0 |
0.3 |
|
|
swelling |
1 |
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:
- On the ground of the study the test item Mn (II) IDHA:
- it does not irritate the rabbit eye – 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),
- it is beyond the categorization – according to the Regulation (EC) of the European Parliament and of the Council No 1272/2008 of 16 December, 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006. - Executive summary:
The acute eye irritation/corrosion study was performed in order to obtain information on health risk of Mn (II) IDHA in eyes of three (females) New Zealand White rabbits (Somat, 2013; Project No. ODR – 13/11). The study was commenced with the sighting study on one animal. The powdered test item was administered as a single dose in amount of 0.065 g (it was volume of 0.1 mL) to conjunctival sack of one eye of animal (rabbit No 1). The second eye served as the control. The animal was observed for 72 hours. After evaluation of the treated eye, the test item was given to eyes of another two animals (rabbit No 2 and No 3). Manner of proceeding was the same as in case of rabbit No 1. The animals were observed for period for 72 hours. General clinical observations for morbidity and mortality were performed in animals daily during the entire experiment. Detailed clinical observations for changes in cornea, iris and conjunctiva were performed after 1, 24, 48 and 72 hours since administration of test item. Body weight of animals was determined directly before administration on day of test item administration (day 0) and on the last day of experiment. After period of observation the animals were humanely sacrificed.
No mortalities or clinical signs were noted in treated animals. Following administration of test item no pathological changes were stated in cornea and iris of treated eyes. The conjunctival changes were present in three animals. They included erythema and swelling: injection of some blood vessels; congestion of nictating membrane; circumcorneal injection and crimson colour, slight swelling of conjunctivae, swelling of nictating membrane, slight volume of discharge and slight discharge on lids and lid’s hair. The changes were transient:
Administered volume of test item
0.1 mL
Number of rabbit
1
2
3
Sex
female
female
female
Mortality
0/1
0/1
0/1
General clinical signs
none
none
none
PART OF EYE
Changes in eye
CORNEA
none
none
none
IRIS
none
none
none
CONJUNCTIVA
erythema
Transient: injection of some blood vessels; congestion of nictating membrane; circumcorneal injection
Transient: diffuse, crimson colour; injection of some blood vessels; congestion of nictating membrane; circumcorneal injection
Transient: injection of some blood vessels; congestion of nictating membrane; circumcorneal injection
swelling
Transient: slight swelling; swelling of nictating mebrane
Transient: slight swelling; swelling of nictating mebrane
Transient: slight swelling; swelling of nictating mebrane
other
Slight volume of discharge
Discharge on lids and lids' hair
Slight volume of discharge
On the ground of the study the test item Mn (II) IDHA:
- it does not irritate the rabbit eye – 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),
- it is beyond the categorization – according to the Regulation (EC) of the European Parliament and of the Council No 1272/2008 of 16 December, 2008 on classification, labeling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No 1907/2006.
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