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EC number: 231-869-6 | CAS number: 7773-01-5
- 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:
- 2009-12-03 to 2009-12-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to current guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Manganese dichloride
- EC Number:
- 231-869-6
- EC Name:
- Manganese dichloride
- Cas Number:
- 7773-01-5
- Molecular formula:
- Cl2Mn
- IUPAC Name:
- manganese(2+) dichloride
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): MnCl2 (Eramet)
- Substance type: light pink solid flakes
- Physical state: solid
- Analytical purity: not provided
- Lot/batch No.: 104896-05
- Expiration date of the lot/batch: not provided
- Date received: 2008-09-08
- Stability under test conditions: not provided
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd. Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.32 to 2.72 kg
- Housing: housed individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet (supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK), available ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30-70%
- Air changes: at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): lighting controlled by a time switch to give 12 h of continuous light (06:00 to 18:00) and 12 h of darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g of test material moistened sufficiently with 0.5 mL of distilled water to achieve a paste - Duration of treatment / exposure:
- Animals were exposed to the test material for 4 hours.
- Observation period:
- Observations were made immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later.
- Number of animals:
- 3 animals
- Details on study design:
- TEST SITE
- Area of exposure: the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: the trunk of each rabbit was wrapped in an elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application
SCORING SYSTEM: The test material was classified according to the Draize JH (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of the United States, Austin, Texas, p. 46-59.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- on 3 animals
- Time point:
- other: 24 and 72 h
- Score:
- 4
- Max. score:
- 6
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 68699
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 68700
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 68701
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 68699
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 68700
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in Table 1.
Well-defined erythema and very slight oedema were noted at one treated skin site at the 24-hour observation with very slight erythema noted at the 48 and 72-hour observations. Slight desquamation was noted at this treated skin site at the 7-day observation.
No evidence of skin irritation was noted at two treated sites during the study. - Other effects:
- not reported
Any other information on results incl. tables
Measurement of pH
The pH of the test material was determined prior to commencement of the study and found to be as follows:
Preparation |
|
||
immediately |
after 10 minutes |
|
|
10 % w/w aqueous preparation of the test material |
7.1 |
7.2 |
|
Table 1: Individual Skin Reactions
Skin Reaction |
Observation Time (Following Patch Removal) |
Individual Scores – Rabbit Number and Sex |
Total |
||
68699 Male |
68700 Male |
68701 Male |
|||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
(0) |
1 Hour |
0 |
0 |
0 |
(0) |
|
24 Hours |
0 |
0 |
2 |
2 |
|
48 Hours |
0 |
0 |
1 |
(1) |
|
72 Hours |
0 |
0 |
1 |
1 |
|
7 Days |
0 |
0 |
0D |
(0) |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
(0) |
1 Hour |
0 |
0 |
0 |
(0) |
|
24 Hours |
0 |
0 |
1 |
1 |
|
48 Hours |
0 |
0 |
0D |
(0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
7 Days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-hour Readings (S): 4 |
|||||
Primary Irritation Index (S/6): 4/6 = 0.7 |
|||||
Classification: Mild Irritant |
() = total values not included in calculating the primary irritation index
D = Slight desquamation
Table 2: Individual Bodyweights and Bodyweight Changes
Rabbit Number and Sex |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 7 |
||
68699 Male |
2.40 |
2.53 |
0.13 |
68700 Male |
2.72 |
2.85 |
0.13 |
68701 Male |
2.32 |
2.51 |
0.18 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- MnCl2 is not a dermal irritant.
- Executive summary:
Introduction:
The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
Results:
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema, very slight oedema and slight desquamation at one treated skin site. No evidence of skin irritation was noted at two treated skin sites.
Conclusion:
The test material produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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