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EC number: 233-828-8 | CAS number: 10377-66-9
- 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
- Remarks:
- other: ex-vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and conducted to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The neat test material was applied for 240 minutes. Negative and positive control materials were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Manganese dinitrate tetrahydrate
- IUPAC Name:
- Manganese dinitrate tetrahydrate
- Details on test material:
- - Molecular formula : Mn(NO3)2.4H2O
- Physical state: solid
- Storage condition of test material: in the dark at 4°C
Constituent 1
Test animals / tissue source
- Species:
- other: Adult Bovine eyes sourced from local abattoir as a by-product of freshly slaughtered animals.
- Strain:
- other: Cattle
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: no control animals were used, but three bovine eyes were used for both the positive and negative controls
- Amount / concentration applied:
- Not reported
- Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- No animals were used, but three bovine eyes were used.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the neat test material and control materials were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Opacity Measurement
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability Measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated corneaThe OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
In Vitro Irritancy Score
The following formula was used to determine the in vitro score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test material induced a response through only one of the two endpoints
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean opacity value + (15 x mean OD492 value)
- Time point:
- other: 4 hours
- Score:
- 82.7
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Not reported
- Other effects:
- Not reported
Any other information on results incl. tables
Evaluation of results:
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro irritancy Score.
Opacity measurement:
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability measurement:
The corrected OD492was calculated by subtracting the mean OD492of the negative control corneas from the OD492value of each treated cornea. The OD492value of each treatment group was calculated by averaging the corrected OD492values of the treated corneas for the treatment group.
In vitro irritancy score:
The following formula was used to determine the in vitro score:
In VitroIrritancy Score = mean opacity value + (15 x mean OD492value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test material induced a response through only one of the two endpoints. Visual observation The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.
Visual observation
The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement
Data interpretation
A test material that induces an in vitro irritancy score >= 55.1 is defined as an ocular corrosive or severe irritant.
Corneal opacity and permeability measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
Corneal epithelium condition
The condition of the cornea immediately after rinsing is given in Table 2.
The corneas treated with the test material or positive control material were cloudy post treatment. The corneas treated with the negative control material were clear post treatment.
In Vitro Irritancy Score
The results are summarised as follows:
Treatment |
In Vitro Irritancy Score |
Classification |
Test Material |
82.7 |
severe irritant |
Negative Control |
1.5 |
mild irritant |
Positive Control |
119.8 |
severe irritant |
Table1 Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
||||
Pre-Treatment |
Post-Treatment |
Post-Treatment-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
1 |
2 |
1 |
|
0.026 |
|
|
2 |
2 |
3 |
1 |
|
0.027 |
|
|
|
3 |
1 |
2 |
1 |
|
0.039 |
|
|
|
|
|
|
1.0* |
|
0.031¨ |
|
1.5 |
|
Positive Control |
7 |
1 |
74 |
73 |
72.0 |
3.425 |
3.394 |
|
8 |
1 |
74 |
73 |
72.0 |
2.490 |
2.459 |
|
|
9 |
1 |
71 |
70 |
69.0 |
3.940 |
3.909 |
|
|
|
|
|
|
71.0· |
|
3.254· |
119.8 |
|
Test Material |
4 |
1 |
76 |
75 |
74.0 |
0.336 |
0.305 |
|
5 |
1 |
80 |
79 |
78.0 |
0.303 |
0.242 |
|
|
6 |
2 |
87 |
85 |
84.0 |
0.257 |
0.226 |
|
|
|
|
|
|
78.7· |
|
0.268· |
82.7 |
OD= Optical density * = Mean of the post treatment-pre‑treatment values ¨= Mean permeability ·= Mean corrected value
Table2 Corneal Epithelium Condition
Treatment |
Cornea Number |
Observation |
Immediately after Rinsing |
||
Negative Control |
1 |
clear |
2 |
clear |
|
3 |
clear |
|
Positive Control |
7 |
cloudy |
8 |
cloudy |
|
9 |
cloudy |
|
Test Material |
4 |
cloudy |
5 |
cloudy |
|
6 |
cloudy |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Conclusions:
- The test material is corrosive to the eyes and requires classification as R41 and Cat 1 eye irritant.
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