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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-12-07 to 2010-02-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to the 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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: MnCl2 (Eramet)
- Substance type: light pink solid flakes
- Physical state: solid
- Lot/batch No.: 104896-05
- Date received: 2008-09-08
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.32 or 2.65 kg
- Housing: individually housed in suspended cages
- Diet: 2030 Teklad Global Rabbit (Harlan Teklad, Blackthorn, Bicester, Oxon, UK), available ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod: the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg of the test material was placed into the conjunctival sac - Duration of treatment / exposure:
- Single application of the test material; up to 72 hours exposure.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 2 animals
- Details on study design:
- APPLICATION OF THE TEST MATERIAL:
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. 100 mg of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent the loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale (Appendix 1).
After consideration of the ocular responses produced in the first treated animal, a second animal was treated. In order to minimise pain on application of the test material, one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of the second animal 1 to 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2 (from Draize JH (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects.
SCORING SYSTEM: modified Kay and Calandra classification system (Kay JH and Calandra JC (1962), J Soc Cosmet Chem. 13, 281-289) (see Appendix 3)
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A+B+C) x 2
Score for iris = D x 5
Score for cornea = (E+F) x 5
Using the numerical data obtained a modified version of the system described by Kay and Calandra (1962) (Appendix 3) was used to classify the ocular irritancy potential of the test material. This was achieved by adding the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reaction enabled classification of the eye irritancy potential of the test material. If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 53
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 68714
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 68794
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 68714
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 68794
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 68714
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 68794
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 68714
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 68794
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table2.
Scattered or diffuse corneal opacity was noted in the treated eyes at the 24-hour observation with translucent or scattered or diffuse corneal opacity noted at the 48 and 72-hours observations. Translucent corneal opacity was noted in the treated eyes at the 7-day observation. Scattered or diffuse corneal opacity was noted in one treated eye at the 14 and 21-day observations. Vascularisation with a localised ingrowth of vessels for approximately 3 mm and covering one or three quarters of the cornea was noted in the treated eyes at the 7-day observation.
Iridial inflammation was noted in the treated eyes at the 24, 48, 72-hour and 7-day observations.
Moderate conjunctival irritation was noted in the treated eyes one hour after treatment with severe conjunctival irritation noted at the 24 and 48-hour observation with moderate conjunctival irritation at the 7-day observation. Minimal or moderate conjunctival irritation was noted in the treated eyes at the 14-day observation with minimal conjunctival irritation at the 21-day observation. Haemorrhage scattered over the nictitating membrane and of the upper and lower conjunctival membrane were noted in the treated eyes at the 24, 48, 72-hour and 7-day observations. Alopecia around the treated eye was noted in one animal at the 7 and 14-day observations. Ectropion was noted in one treated eye at the 21-day observation. - Other effects:
- not reported
Any other information on results incl. tables
Table 1: Individual Scores for Ocular Irritation
Rabbit Number and Sex |
68714 Male |
68794 Male |
||||||||||||
IPR= 3 |
IPR= 0+ |
|||||||||||||
Time After Treatment |
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
1 h |
24 h |
48h |
72 h |
7 d |
14 d |
21 d |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
1 |
1 |
1 |
2V |
0 |
0 |
0 |
1 |
2 |
2 |
2V. |
1 |
1 |
F = Area of Cornea Involved |
0 |
4 |
4 |
3 |
1 |
0 |
0 |
0 |
4 |
4 |
3 |
3 |
3 |
1 |
Score (E x F) x 5 |
0 |
20 |
20 |
15 |
10 |
0 |
0 |
0 |
20 |
40 |
30 |
30 |
15 |
5 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
Score (D x 5) |
0 |
5 |
5 |
5 |
5 |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
0 |
0 |
CONJUNCTIVA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
3H |
3H |
3H |
2HP |
1P* |
0 |
2 |
3H |
3H |
3H |
2HP AI |
2PAI
|
1Ec |
B = Chemosis |
2 |
3 |
3 |
2 |
2 |
1 |
0 |
2 |
3 |
3 |
3 |
2 |
2 |
1 |
C = Discharge |
2 |
3 |
3 |
2 |
2 |
1 |
1 |
2 |
3 |
3 |
3 |
2 |
2 |
2 |
Score (A + B + C) x 2 |
12 |
18 |
18 |
14 |
12 |
6 |
2 |
12 |
18 |
18 |
18 |
12 |
12 |
6 |
Total Score |
12 |
43 |
43 |
34 |
27 |
6 |
2 |
12 |
43 |
63 |
53 |
47 |
27 |
11 |
IPR= Initial pain reaction + = one drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
V = vascularisation, with localised ingrowth of vessels for approx. 3 mm and covering ¼ of the cornea
V.= vascularisation, with localised ingrowth of vessels for approx. 3 mm and covering ¾ of the cornea
H = Haemorrhage scattered over the nictitating membrane and upper and lower conjunctival membrane
P = off white/pale area covering lower half of nictitating membrane and half of the lower conjunctival membrane
P* = off white/pale area covering lower half of nictitating membrane
Al = alopecia around the treated eye
Table 2: Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
||||||
1 h |
24 h |
48 h |
72 h |
7d |
14 d |
21 d |
|
68714 Male |
12 |
43 |
43 |
34 |
27 |
6 |
2 |
68794 Male |
12 |
43 |
63 |
53 |
47 |
27 |
11 |
Group Total |
24 |
86 |
106 |
87 |
74 |
33 |
13 |
Group Mean Score |
12.0 |
43.0 |
53.0 |
43.5 |
37.0 |
16.5 |
6.5 |
Table 3: Individual Bodyweights and Bodyweight Changes
Rabbit Number and Sex |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 21 |
||
68714 Male |
2.65 |
3.05 |
0.40 |
68794 Male |
2.32 |
2.82 |
0.50 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The hazard phrase H318: "Causes serious eye damage" is therefore required due to irreversible ocular damage (based on two rabbits).
- Executive summary:
Introduction:
The study was performed to assess the irritancy potential of the test material following a single application to the eye 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. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002) and Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.
Result:
A single application of the test material to the non-irrigated eye of two rabbits produced translucent corneal opacity, iridial inflammation and severe conjunctival irritation. Other corneal effects noted were vascularisation with a localised ingrowth of vessels for approximately 3 mm, haemorrhage over the nictitating and conjunctival membranes and an off white/pale area covering the conjunctival membrane and/or nictitating membrane.
Conclusion:
The test material produced a maximum group mean score of 53.0 and was classified as a severe irritant (Class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
In accordance with CLP Regulation (1272/2008), the hazard phrase H318: "Causes serious eye damage" is required due to irreversible ocular damage (based on two rabbits).
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