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EC number: 939-867-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
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- 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
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- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2013-08-06 to 2013-10-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented 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 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- issued by the Bureau for Chemical Substances
- Type of study:
- guinea pig maximisation test
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: granules solved in aqua pro injectione
- Details on test material:
- - Name of test material (as cited in study report): Mn (II) IDHA
- Substance type: chelate
- Physical state: solid (odourless, white microgranules)
- Composition of test material, percentage of components: 9.07 % of Cu2+, 56.7% of MnIDHA, 40% of Na2SO4, and 3% of H2O (humidity)
- Lot/batch No.: 7/13, produced in June, 2013
- Expiration date of the lot/batch: June, 2016
- Storage condition of test material: at temperature between 0 – 30°C
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories in Germany and France
- Age at study initiation: from 8 to 14 weeks old - Pilot study and 9 weeks - Main study
- Weight at study initiation: 590.3 g (males) and 524.7 g (females) - Pilot study
and 510.7 g (males) and 446.0 g (females) - Main study
- Housing: individually in plastic cages. The dimensions of the cages were 58 x 37 x 21 cm (length x width x height ). The cages were covered with wire bar lids. UV-sterilized wood shavings were used as bedding [SOP/T/16, SOP/T/48].
- Diet (e.g. ad libitum): ad libitum standard granulated LSK standard granulated fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum tap drinking water with supply of ascorbic acid (0.6% solution)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24 ºC
- Humidity (%): 35 – 89 %
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Start of the study: 02.08.2013
Start of the experimental phase: 06.08.2013
End of the experimental phase: 19.10.2013
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: aqua pro injectione
- Concentration / amount:
- induction - intradermal injections: 15 % (causing mild changes)
induction - topical application: 50 % (not causing changes on skin)
challenge - topical application: 50 % (not causing changes on skin)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: aqua pro injectione
- Concentration / amount:
- induction - intradermal injections: 15 % (causing mild changes)
induction - topical application: 50 % (not causing changes on skin)
challenge - topical application: 50 % (not causing changes on skin)
- No. of animals per dose:
- treated group:20
control group: 10 - Details on study design:
- RANGE FINDING TESTS:
The experiment was commenced by the pilot study in which concentrations of test item for the main study were established. On the day before the test, an electric razor was used to shave the dorsal and flank skin of the animals covering the area of about 4.5 x 6 cm. Only animals without any visible skin i rritation or abrading were used in the experiment. In order to prepare appropriate concent rations of the test item, aqua pro injectione was used as a medium.
Concentration determination for stage I of the main study:
In order to determine a proper concent ration for stage I, i.e. induction – intradermal injections, six intradermal injections in a volume of 0.1 mL each were given in the shoulder region of four guinea pigs. The injections were as follows: 2 with Freund’s Complete Adjuvant (FCA), 1 with the medium, and 3 with appropriate concentrations of the test item. Guinea pig no. 1 received the test item at the concentrations of 0.5%, 1%, and 2%, guinea pig no. 2 received the test item at the concentrations of 4%, 6%, and 8%, guinea pig no. 3 received the test item at the concentrations of 10%, 15%, and 20%, and guinea pig no. 4 received the test item at the concentrations of 15%, 17%, and 20%.
Concentration determination for stages II and III of the main study:
In order to determine proper concentrations to be used at stage II of the main study (induction – topical application) and stage III of the main study (challenge – topical application), the test item at the concentrations of 30% and 50% (guinea pig no. 1) and 40% and 50% (guinea pigs no. 2 and 3) was
applied to the shaved flanks of three guinea pigs. Two concentrations were tested on each animal. Aqueous solutions of the test item at the appropriate concentrations in a volume of 0.5 mL each were applied to gauze patches (2 x 2 cm). Then, the patches were laid on the flanks of the animals and covered with PVC foil and an elastic bandage. The exposure time was 24 hours. Following this period of time, the bandage and the gauze patches were removed from the skin
Clinical observations
These observations comprised the evaluation of general condition of the animals and detailed clinical observations of their skin. The general observations of all animals for mortality and morbidity were conducted twice a day or once a day in case of days off. In the pilot study, the detailed observations of the animals’ skin were performed 24, 48, 72, 96, and 120 hours after the intradermal injections and 24, 48, 72, 96, and 120 hours after the end of the 24-hour exposure following the test item application. Skin reactions to intradermal injections (the test item and the medium) were evaluated by measuring the diameter of erythema. All other skin changes were also recorded. Skin reactions to the test item were evaluated according to the grading scale based on the OECD Guideline No. 404, the EU Method B.4., and the Standard Operating Procedure SOP/T/24. After the observation period, the animals were euthanized by intraperitoneal administration of morbital at a dose of 200 mg/kg b.w. [SOP/T/39] and trans ferred to utilization.
Body weights
Body weights of the animals were determined on day 0 and on the day of the experiment termination (before euthanasia)
MAIN STUDY
The main study comprised three parts: double induction and a challenge.
A. INDUCTION EXPOSURE
- No. of exposures: 2 (on day 0 an intradermal injection and on day 7 a dermal application)
- Exposure period: 48 hours
- Test and control groups: In the I step of main study the animals of treated group were given intradermally 15% aqueous solution of test item with Freund’s Complete Adjuvant (FCA) and 15 % aqueous solution of test item without FCA.
In the II step of main study, 50% aqueous solution of test item was applied to skin in the site of intradermal injections. Due to no skin irritation after aplication of 50% aqueous solution,10% sodium lauryl sulfate in vaseline was applied in the site of intradermal injections on day before II step of experiment in order to create local skin irritation. During period of induction a group of control animals was subjected to sham treatment – they were given medium instead of test item.
- Site: dorsal skin of animals’ trunk and flanks
- Frequency of applications: one intradermal injection and one dermal application
- Duration: dermal application: 48 hours
- Concentrations: 15 % and 50 % aqueous solution
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Test and control groups: In order to challenge sensitization the 50% aqueous solution of test item was applied to right flank of treated and control animals. Medium was applied to left flank. During period of induction a group of control animals was subjected to sham treatment – they were given medium instead of test item.
- Site: right flank
- Concentrations: 50 % aqueous solution
- Evaluation (hr after challenge): 24, 48 and 72 hours since the end of exposure - Challenge controls:
- During period of induction a group of control animals was subjected to sham treatment – they were given medium instead of test item. During challenge, 50 % aqueous solution of test item was applied to right flank of control animals. Medium was applied to left flank.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable as no positive controls were used
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Results of the pilot study
Clinical signs
The test item at the concentration of 15% causing mild skin changes was selected for stage I of the main study.
The results of the pilot study allowed for the determination of the test item concentration of 50% causing no skin changes to be used at stage II of the main study (induction – topical application). Because the test item was a solid, the maximum concentration of the test item applied to the skin could be 50%.
The concentration of 50% causing no skin changes was selected for stage III of the main study (challenge – topical application).
Body weights of the animals
After the termination of the pilot study, insignificant body weight loss was stated in three animals (no. 2/241, 3/134, and 2/228)
Results of the main study
Clinical observations
During the readings which took place 24, 48, and 72 hours after the end of the exposure, the control group animals did not exhibit any pathological changes in the sites of the test item and the medium application. During the readings which took place 24, 48, and 72 hours after the end of the exposure, the treated group animals did not exhibit any pathological changes in the sites of the test item and the medium application. On the grounds of the obtained results, it may be stated that no allergic skin reactions occurred in the treated animals. During the experiment, the control and the treated animals did not reveal any changes in behaviour or general clinical changes.
Table 3: Summary of results
Mn (II) IDHA.Skin sensitization study | ||
CONTROL GROUP | TREATED GROUP | |
Number of animals in group | 10 | 20 |
Number of animals subjected to the final assessment | 10 | 20 |
Number of accidently dead animals | 0/10 | 0/20 |
Skin changes in the medium application site following challenge | no changes | no changes |
Skin changes in the test item application site following challenge | no changes |
no changes |
No. of animals exhibiting allergic reactions | 0/10 | 0/20 |
% of sensitized animals | - | 0 % |
During the readings, the treated animals did not exhibit any allergic skin reactions.
Taking the study results into consideration, the test item, i.e. Mn (II) IDHA can be classified into the following categories:
- agents causing no sensitization – according to the Magnusson and Kligman classification,
- agents which are beyond categorization – according to the Commission Regulation (EU) No. 286/2011
of March 10, 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling, and packaging of substances and mixtures.
Body weight loss stated in three animals was probably caused by stress resulting from the preparation of the animals for the experiment, the way of protecting the test item and/or the medium, and observations.
Table 4. Main study -challenge-topical application (patch test)-control group. | ||||||||
Test item: | 50% | flank: | right | |||||
Medium: | aqua pro injectione | flank: | left | |||||
Date of application: | 15.10. 2013. | |||||||
Date of removal: | 16.10 .2013. | |||||||
Evaluation of skin reactions according to the grading scale of Magnusson and Kligman | ||||||||
(based on theOECDGuideline No.406 / EUMethod B.6.) | ||||||||
Animal No. | Evaluation after [h] | |||||||
Sex | comp. | reg. | 24 | 4S | 72 | |||
left flank | right flank | left flank | right flank | left fank | right flank | |||
males | 1 | 46 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 54 | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 5S | 0 | 0 | 0 | 0 | 0 | 0 | |
4 | 65 | 0 | 0 | 0 | 0 | 0 | 0 | |
5 | 66 | 0 | 0 | 0 | 0 | 0 | 0 | |
females | 6 | 106 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 10S | 0 | 0 | 0 | 0 | 0 | 0 | |
8 | 124 | 0 | 0 | 0 | 0 | 0 | 0 | |
9 | 126 | 0 | 0 | 0 | 0 | 0 | 0 | |
10 | 135 | 0 | 0 | 0 | 0 | 0 | 0 | |
0 - no visible changes, 1 - discrete or patchy erythema, 2 - moderate or confluent erythema, 3 - intense erythema and swelling |
Table 5. Main study - challenge - topical application (patch test) - treated group. | ||||||||||
Test item concentration: | 50% | flank: | right | |||||||
Medium: | aqua pro injectione | flank: | left | |||||||
Date of application: | 15.10. 2013 | |||||||||
Date of removal: | 16.10. 2013 | |||||||||
Evaluation of skin reactions according to the grading scale of Magnusson and Kligman | ||||||||||
(based on the OECD Guideline No. 406 /EU Method B.6.) | ||||||||||
Sex | Animal No. | Evaluation after [h] | Animals with/without allergic reactions (+/-) | %of sensi tized animals |
||||||
comp. | reg. | 24 | 4S | 72 | ||||||
left flank | right flank | left flank | right flank | left flank | right flank | |||||
males | 1 | 36 | 0 | 0 | 0 | 0 | 0 | 0 | - | 0% |
2 | 39 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
3 | 40 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
4 | 42 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
5 | 43 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
6 | 44 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
7 | 47 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
8 | 51 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
g | 52 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
10 | 67 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
females | 11 | 10g | 0 | 0 | 0 | 0 | 0 | 0 | - | |
12 | 114 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
13 | 118 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
14 | 120 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
15 | 125 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
16 | 128 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
17 | 129 | 0 | 0 | 0 | 0 | 0 | 0 | |||
18 | 130 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
19 | 131 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
20 | 133 | 0 | 0 | 0 | 0 | 0 | 0 | - | ||
0 - no vsible changes, 1 - discrete or patchy erythema, 2 - moderate or confluent erythema, 3 - intense erythema and swelling |
Body weights of the animals
During the main study, body weight gain was stated in all animals. The average body weight gain was 127.2 g in the control males, 115.4 g in the treated males, 73.0 g in the control females, and 77.3 g in the treated females .
Table 6. Main study - body weights [g] - control group. | |||||||
Sex | Animal No. | Day of experiment | Body weight gain [g] | ||||
comp. | reg. | 0 | final | ||||
males | 1 | 46 | 530 | 657 | 127 | ||
2 | 54 | 493 | 604 | 111 | |||
3 | 58 | 478 | 613 | 135 | |||
4 | 65 | 535 | 668 | 133 | |||
5 | 66 | 518 | 648 | 130 | |||
females | 6 | 106 | 473 | 560 | 87 | ||
7 | 108 | 437 | 500 | 63 | |||
8 | 124 | 447 | 534 | 87 | |||
9 | 126 | 452 | 522 | 70 | |||
10 | 1135 | 425 | 483 | 58 | |||
Average body weight [g] | Average body | ||||||
initial | final | weight gain [g] | |||||
males | 510.8 | 638.0 | 127.2 | ||||
femals | 446.8 | 519.8 | 73.0 |
Table 7. Main study - body weights [g] - treated group. | |||||
Animal No. | Day of experiment | Body weight gain [g] | |||
Sex | comp. | reg. | 0 | final | |
males | 1 | 36 | 491 | 612 | 121 |
2 | 39 | 493 | 640 | 147 | |
3 | 40 | 476 | 552 | 76 | |
4 | 42 | 548 | 708 | 160 | |
5 | 43 | 517 | 625 | 108 | |
6 | 44 | 486 | 591 | 105 | |
7 | 47 | 467 | 567 | 100 | |
8 | 51 | 550 | 732 | 182 | |
9 | 52 | 532 | 628 | 96 | |
10 | 67 | 546 | 605 | 59 | |
females | 11 | 109 | 469 | 538 | 69 |
12 | 114 | 428 | 497 | 69 | |
13 | 118 | 418 | 513 | 95 | |
14 | 120 | 388 | 459 | 71 | |
15 | 125 | 444 | 486 | 42 | |
16 | 128 | 487 | 593 | 106 | |
17 | 129 | 447 | 534 | 87 | |
18 | 130 | 481 | 550 | 69 | |
19 | 131 | 398 | 493 | 95 | |
20 | 133 | 496 | 566 | 70 | |
Average body weight [g] | Average body | ||||
initial | final | weight gain [g] | |||
males | 510.6 | 626.0 | 115.4 | ||
femals | 445.6 | 522.9 | 77.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Mn (II) IDHA caused no sensitization in animals. On the ground of the study Mn (II) IDHA may be included to the agents not causing sensitization of skin of guinea pigs.
- Executive summary:
A study was undertaken to investigate the skin sensitisation potential of Mn (II) IDHA in Dunkin Hartley guinea pigs (Kropidło, 2013, Study Code Al 9/13, according to OECD 406). The experiment commenced with a pilot study which allowed for the determination of the test item concentrations to be used in the main study. These were as follows: 15% causing mild skin changes at stage I (induction - intradermal injections), 50% causing no skin changes at stage II (induction – topical application), and 50% causing no skin changes at stage III (challenge – topical application). Because the test item was a solid, the maximum concentration of the test item applied to the skin could be 50%. There were 20 animals in the treated group and 10 animals in the control group used in the main study. The main study was comprised of three parts: a two-stage induction phase and a challenge phase. At stage I of the main study, the treated animals were given intradermal injections containing a 15% aqueous solution of the test item with Freund’s Complete Adjuvant (FCA). At stage II of the main study, a 50% aqueous solution of the test item was applied to the skin in the sites of the intradermal injections. Since the 50% aqueous solution did not cause skin irritation, on the day before stage II of the main study 10% sodium lauryl sul fate in vaseline was applied in the sites of the intradermal injections in order to create a local skin irritation.
During the induction period, the control group animals were subjected to sham treatment. In order to challenge sensitization, a 50% aqueous solution of the test item was applied to the right flanks of the treated and the control animals. The medium was applied to the left flanks. Following the challenge, i.e. 24, 48, and 72 hours after the end of the exposure, the treated and the control animals were observed for skin changes. General clinical observations were performed during the main study. Detailed skin observations were conducted 24, 48, and 72 hours after the end of the exposure. Body weights of the animals were determined on day 0 and on the day of the experiment termination (before euthanasia). All animals survived the experiment. After the observation period, the animals were euthanized.
During all readings, the treated animals did not exhibit any allergic skin reactions. In the cont rol group animals, no pathological skin changes were stated. During the experiment, the observed animals did not exhibit any general clinical signs. After the end of the experiment, body weight gain was stated in all animals. Based on the study results, the test item, i.e. Mn (II) IDHA can be classified as an agent causing no sensitization – according to the Magnusson and Kligman classification.
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