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EC number: 231-869-6 | CAS number: 7773-01-5
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
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- Particle size distribution (Granulometry)
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial specific surface area
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- Endpoint summary
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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
Endpoint summary
Administrative data
Description of key information
In vitro assays for skin and eye irritation were followed up with in vivo studies which confirm that MgCl2 was non-irritating to skin, but caused serious damage to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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)
- 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 - 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. - 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- 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)
- 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 - 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. - 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
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for selection of skin irritation / corrosion endpoint:
GLP Guideline compliant in vivo study.
Justification for selection of eye irritation endpoint:
GLP Guideline compliant in vivo study.
Effects on eye irritation: corrosive
Effect level: empty Endpoint conclusion: Adverse effect
observed
Justification for classification or non-classification
MnCl2 is not irritating to skin, based on an in vivo study in rabbit (IUCLID section 7.3.1, Pooles A). MnCl2 is irritating to the eyes and should be classified as Eye Damage Cat. 1 on the basis of the severity of the effects seen (IUCLID section 7.3.2, Pooles A)
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