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EC number: 944-341-1 | CAS number: -
- 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
- Remarks:
- study acc. OECD 404 conducted in 1998
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 13-08-1998 till 08-09-1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The underlying hypothesis for the read-across is that chelates have the same mode of action based on their ability to chelate, remove or add metal cations to body causing perturbation of body’s micronutrients balance.
The source substance is a chelating agent in a target substance. The only difference between the target and the main source substance is presence of calcium (Ca) cation instead two Na+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2010-11-09 to 2010-11-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP-Guideline Study
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. The source substance has the same chelating agent as in a target substance (CaNa2IDHA). The only difference between the target and the source substance is presence of calcium (Ca) cation instead Cu2+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/22: “Acute skin irritation/corrosion study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service (No. G-024)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Department of National Research Institute of Animal Production, Balice near Kraków
- Age at study initiation: 9-month-old rabbit female (rabbit No 1), 8.5-month-old male (rabbit No 2) and one 8-month-old male (rabbit No 3)
- Housing: individually in metal cages (60 x 35 x 40 cm). Each cage was equipped with label containing information on number of study protocol, start and end date of experiment (written after termination), sex and animal’s number
- Diet (e.g. ad libitum): ad libitum standard granulated "LSK" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23;
- Humidity (%): 47 – 84
- Air changes (per hr): about 16 times/h
- Photoperiod (hrs dark / hrs light): 12 / 12
Study commencement: 09.11.2010.
Experiment: from 09.11.2010. to 12.11.2010. (rabbit No 1)
from 16.11.2010. to 19.11.2010. (rabbit No 2 and No 3) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0,5 g (powdered test item)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze patches were covered with PCV foil and fixed with sticking plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using water
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for 3 animals
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- No irritating effects were noted.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- During readings no pathological changes were stated on treated skin of rabbits. The test item Cu (II) IDHA does not irritate skin of rabbits.
- Executive summary:
A study was undertaken to investigate the skin irritation potential of Cu (II) IDHA in New Zealand White rabbits (OECD 404; Kropidło, 2010, Report No. DDR-15/10). A dose of 0.5 g then was applied to a shaved, unabraded site on one animal. The powdered test item was applied in amount of 0.5 g as a single dose (applied first to multilayered gauze patch with dimensions of 2.5 x 2.5 cm, moistened with few drops of water and then laid on prepared skin) to shaved skin of one animal (rabbit No 1) and covered with appropriate band. The area of skin surface treated with the test item was about 6 cm². The gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbits trunk was covered with lignin and elastic bandage was used to make circular protecting band. After an exposure time of 4 hours, the band and gauze patches were taken off and the residual test item was removed using water. The animal was observed for 72 hours. After evaluation of treated skin, in order to confirm irritation or its lack, the test item was applied to skin of another two animals (rabbit No 2 and No 3) for 4 hours. The test sites were then evaluated in accordance with the method of Draize at 1 hour, 24, 48 and 72 hours.
General clinical observations for morbidity and mortality of all animals were performed daily during the entire experiment. Detailed clinical observations of treated skin were performed after 1, 24, 48 and 72 hours since the end of exposure. Body weight of animals was determined directly before administration on day of administration of test item (day 0) and on last day of experiment. During readings no pathological changes were stated on treated skin of rabbits. No mortality or effects on body weight were observed. The test item Cu (II) IDHA does not irritate skin of rabbits.
Based on the results of this study this substance is not classified as a skin irritant in accordance with EU CLP Regulation (EC) No. 1272/2008.
Table 1: Summary of Cu (II) IDHA. Acute skin irritation/corrosion on rabbits | |||
Administered amount of test item | 0.5 g | ||
Number of rabbit | 1 | 2 | 3 |
Sex | female | male | male |
Mortality of animals | 0/1 | 0/1 | 0/1 |
General clinical signs | none | none | none |
Skin erythema in area of treatment | none | none | none |
Skin oedema in area of treatment | none | none | none |
Other | none | none | none |
During the entire experiment, no pathological changes were stated on treated skin of rabbits.
Table 2 - Point evaluation of acute skin irritation/corrosion on rabbits | ||||||
Acute skin irritation/corrosion on rabbits | ||||||
Cu (II) IDHA | ||||||
Rabbit No | Observation type | Evaluation after | Average after24, 48and72hours | |||
1hour | 24hours | 48hours | 72hours | |||
1 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
2 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
3 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 |
Body weight of animals
At the start of experiment animal No 1 weighed 3.7 kg, animal No 2 – 3.5 kg and animal No 3 – 3.6 kg.
At the end of experiment animal No 1 weighed 3.6 kg, animal No 2 – 3.5 kg and animal No 3 – 3.6 kg
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 23.05 - 27.06.2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP-Guideline Study
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. The source substance has the same chelating agent as in a target substance (CaNa2IDHA). The only difference between the target and the source substance is presence of calcium (Ca) cation instead Fe3+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three white rabbits of New Zealand strain coming from conventional Reproductive Farm of Rabbits, Balice were used in the test.
The rabbits were quarantined for at least 5 days and observed carefully during this time.
One 5.5-month-old male rabbit weighing 4,02 kg and two 6 and 5-month-old female rabbits weighing 2.99 kg and 3.11 kg were used in the study.
During quarantine and experiment the animals were kept in air-conditioned rooms with the following parameters:
- temperature: 18 - 22 °C;
- relative air humidity: 50 - 80%;
- artificial fluorescent lighting: 12 hours light / 12 hours darkness.
The animals were kept individually in metal cages with dimensions: 60 x 35 x 40 cm. Each cage was equipped with label containing information on study protocol number, start date of the experiment, sex and animal number.
The animals were given ad libitum standard granulated fodder "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz and drinking tap water. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g unchanged test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations of skin were performed after 1, 24, 48 and 72 hours as well as 7 days since the end of exposure.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: about 6 cm2.
- Type of wrap if used: The
gauze patches were covered with PCV foil and fixed with sticking plaster. The rabbit’s trunk was covered with lignin and elastic bandage was used to make circular protecting band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours of exposure, the band and gauze patches were taken off and the residual test material was removed using water.
- Time after start of exposure: 4 h - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- During observation after 1 hour since the end of exposure, faint erythema (barely visible) was stated on treated skin of all three rabbits.
During observation after 24 hours since the end of exposure, faint erythema (barely visible) was stated on treated skin of rabbits No 1 and 2. No pathological changes on skin of rabbit No 3 were noticed.
During observation after 48 and 72 hours since the end of exposure faint erythema (barely visible) was observed on treated skin of rabbit No 1. Rabbit No 2 showed no pathological changes.
During observation after 7 days no pathological changes on treated skin of rabbit No 1 were stated. - Other effects:
- At the start of the experiment rabbit No 1 weighed 4.02 kg, rabbit No 2 - 2.99 kg while rabbit No 3 - 3.11 kg. At the end of the experiment body weight of rabbits amounted: rabbit No 1 – 4.1 kg, rabbit No 2 – 3.11 kg and rabbit No 3 – 3.27 kg.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Fe (III) IDHA does not irritate skin of rabbits.
- Executive summary:
Acute skin irritation/corrosion study of Chelate with name: Fe (III) IDHA for rabbits was performed according to OECD Guideline for Testing of Chemicals No 404/Method B.4. as well as Principles of Good Laboratory Practice (GLP - OECD, 1997). The study was performed with white rabbits of New Zealand strain. The tested substance was administered in amount of 0.5 g as a single dose to shaved skin of three rabbits and covered with appropriate band. The exposure time was 4 hours. After 1, 24, 48, 72 hours and 7 days since the end of exposure skin condition was examined. During observations all test rabbits showed changes on skin in form of erythema.
Classification of the test material was performed according to Regulation 1272/2008. Taking into account the obtained results, one may state that Chelate with name: Fe (III) IDHA does not irritate skin of rabbits.
Chelate with name: Fe (III) IDHA, Point evaluation of acute skin irritation/corrosion study for rabbits
Rabbit No |
Observation type |
Evaluation after |
Average after 24, 48 and 72 h |
||||
1 h |
24h |
48h |
72 h |
7 days |
|||
1 |
erythema |
1 |
1 |
1 |
1 |
0 |
1 |
oedema |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
erythema |
1 |
1 |
0 |
0 |
- |
0.3 |
oedema |
0 |
0 |
0 |
0 |
- |
0 |
|
3 |
erythema |
1 |
0 |
0 |
0 |
- |
0 |
oedema |
0 |
0 |
0 |
0 |
- |
0 |
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2013-11-06 to 2013-11-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP-Guideline Study
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. The source substance has the same chelating agent as in a target substance (CaNa2IDHA). The only difference between the target and the source substance is presence of calcium (Ca) cation instead Mn2+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/22: “Acute skin irritation/corrosion study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bureau for chemical substances (Registration No. B/2012/DPL
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Experimental Department of National Research Institute of Animal Production, Balice near Kraków
- Age at study initiation: 6-month-old – rabbit No. 1 and 6.5-month-old – rabbit No. 2, and on one 9-month-old female – rabbit No. 3
- Housing: individually in metal cages (60 x 35 x 40 cm (length x width x height)). Each cage was equipped with a label containing the number of the study protocol, the dates of the experiment commencement and termination, and sex and number of the animal.
- Diet (e.g. ad libitum): ad libitum; standard granulated "LSK" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22;
- Humidity (%): 45 – 65
- Air changes (per hr): about 16 times/h
- Photoperiod (hrs dark / hrs light): 12 / 12
Start of the study: 04.11.2013
Start of the experimental phase: 06.11.2013
End of the experimental phase: 11.11.2013 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g (powdered test item)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after the end of the exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze patches were covered with PCV foil and fixed using a non-irritating sticking plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using water
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- During the reading which took place 1 hour after the end of the exposure, no pathological changes on the treated skin of rabbit No. 1 were stated. Very slight (barely perceptible) erythema was stated in rabbit No. 2 and 3.
During the reading which took place 24 hours after the end of the exposure, no pathological changes were stated in rabbits No. 1 and 2. Very slight (barely perceptible) erythema was still observed in rabbit No. 3.
During the reading which took place 48 and 72 hours after the end of the exposure, no pathological changes on the treated skin of the rabbits were stated. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The observations of the treated skin revealed some changes in the form of barely perceptible erythema. The test item Mn (II) IDHA does not irritate skin of rabbits.
- Executive summary:
A study was undertaken to investigate the skin irritation potential of Mn (II) IDHA in New Zealand White rabbits (OECD 404; Sornat, 2013, Report No. DDR-15/13). The study commenced with a sighting study on one animal. The powdered test item was applied in an amount of 0.5 g once to the shaved skin of one animal (rabbit No. 1) and covered with an appropriate band. The exposure lasted 4 hours. After evaluation of treated skin, in order to confirm irritation or its absence, the test item was applied to the skin of the next two animals (rabbit No. 2 and No. 3) for 4 hours in order to confirm its irritant properties. The procedure was the same as in case of rabbit No. 1. General clinical observations of the animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48, and 72 hours after the end of the exposure. Body weights of the animals were determined on the administration day (day 0), i.e. directly before the administration, and on the last day of the experiment. After the observation period, the animals were euthanized.
The observations of the treated skin revealed some changes in the form of barely perceptible erythema.
Table 1: Summary of results:
Administered volume of test item | 0.5 mL | ||
Number of rabbit | 1 | 2 | 3 |
Sex | male | male | female |
Mortality of animals | 0/1 | 0/1 | 0/1 |
General clinical signs | none | none | none |
Skin erythema in the treatment area | none | very slight (barely perceptible) after 1 hour | very slight (barely perceptible) after 1 hour and 24 hours |
Skin oedema in the treatment area | none | none | none |
Other | none | none | none |
Body weight of the animals
At the start of the experiment, animal No. 1 weighed 3.3 kg, animal No. 2 weighed 3.6 kg and animal No. 3 weighed 4.3 kg. On the last day of the experiment, animal No. 1 weighed 3.4 kg, animal No. 2 weighed 3.7 kg and animal No. 3 weighed 4.3 kg.
Interpretation of the study results
On the grounds of the study, the test item, i.e. Mn (II) IDHA can be classified to the following categories:
- does not irritate the rabbit skin – according to the Annex to the Decree of the Minister of Health of August 10, 2012 on classification of chemical substances and mixtures (Journal of Laws, item 1018),
- is beyond categorization – according to the Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of December 16, 2008 on classification, labelling, and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) No. 1907/2006.
The detailed results of the study based on the scoring system presented in the OECD Guideline No. 404 / EU Method B.4. are given in Table 2.
Table 2 - Point evaluation of acute skin irritation/corrosion on rabbits | ||||||
Acute skin irritation/corrosion on rabbits | ||||||
Cu (II) IDHA | ||||||
Animal No | Observation type | Evaluation after | Average after24, 48and72hours | |||
1hour | 24hours | 48hours | 72hours | |||
1 | erythema | 0 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
2 | erythema | 1 | 0 | 0 | 0 | 0 |
oedema | 0 | 0 | 0 | 0 | 0 | |
3 | erythema | 1 | 1 | 0 | 0 | 0.3 |
oedema | 0 | 0 | 0 | 0 | 0 |
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A substantial body of evidence exists that the toxicity profiles of chelates depends mainly on metal ion, its affinity to this metal, and their ability to supply or to sequester it from the body/environment. The source substance has the same chelating agent as in a target substance (CaNa2IDHA). The only difference between the target and the source substance is presence of calcium (Ca) cation instead Zn2+ cations. As calcium is an essential macro element required by all forms of life, is considered not to influence the toxicological activity.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Odchylenia od wytycznej/metody.
W trakcie badania wilgotność względna powietrza kilkakrotnie przekroczyła wartość 70 %. Nie miało to wpływu na przebieg i wyniki badania. Nie stwierdzono innych odchyleń od wytycznej / metody. - GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Zwierzęta.
W doświadczeniu użyto trzech królików białych rasy nowozelandzkiej pochodzących z Instytutu Zootechniki w Balicach.
Króliki przeszły minimum 5-dniowy okres kwarantanny, w czasie którego były pod stałą obserwacją [SPR/T/6].
W dniu przyjęcia zwierząt do kwarantanny wykonano ogólne badanie lekarsko-weterynaryjne, a przed wprowadzeniem do doświadczenia u zwierząt wykonano szczegółowe badanie lekarsko-weterynaryjne [SPR/T/46]. Do doświadczenia wprowadzono zwierzęta nie wykazujące żadnych objawów klinicznych.Wszystkie zwierzęta były indywidualnie oznaczone [SPR/T/7].W doświadczeniu użyto trzech samców w wieku: królik nr 1 - 9 miesięcy, królik nr 2 - 7 miesięcy i królik nr 3 - 11 miesięcy.
Warunki przetrzymywania zwierząt.
W okresie kwarantanny i doświadczenia zwierzęta przebywały w klimatyzowanym pomieszczeniu o następujących parametrach:
- temperatura powietrza 20 - 22 °C
- wilgotność względna powietrza 50 - 90 %
- oświetlenie sztuczne, jarzeniowe; cykl oświetlenia: 12 godzin jasno - 12 godzin ciemno [SPR/T/9].
Zwierzęta przetrzymywano pojedynczo w metalowych klatkach, o wymiarach (długość x szerokość x wysokość): 60x35x40 cm. Każda klatka wyposażona była w wywieszkę zawierającą: numer protokołu badania, datę założenia i zakończenia doświadczenia, płeć i numer zwierzęcia [SPR/T/22].
Pasza i woda.
Zwierzętom podawano bez ograniczeń granulowaną standardową paszę laboratoryjną „LSK", produkowaną przez Wytwórnię Koncentratów i Mieszanek Paszowych AGROPOL z Motycza oraz wodę wodociągową [SPR/T/15].
Przygotowanie zwierząt.
W przeddzień rozpoczęcia doświadczenia, maszynką elektryczną do strzyżenia, usunięto zwierzętom sierść na grzbiecie i obu bokach na dostatecznie dużej powierzchni. Do doświadczenia użyto tylko tych zwierząt, których skóra była nie uszkodzona i nie wykazywała cech przekrwienia [SPR/T/22]. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Badany materiał, po roztarciu na proszek, naniesiono w ilości 0,5 g na kilkuwarstwowy płatek gazy o wymiarach 2,5 * 2,5 cm, zwilżono kilkoma kroplami wody. Następnie płatek gazy nałożono na skórę jednego królika (królik nr 1). Narażana powierzchnia skóry królika wynosiła ok. 6 cm2. Gazę osłonięto folią PCW i przytwierdzono do skóry przylepcem. Tułów królika owinięto warstwą ligniny oraz zabezpieczono elastyczną opaską i przylepcem. Po 4-godzinnym okresie narażania, przylepiec i płatek gazy zdjęto, a pozostałość badanego materiału usunięto ze skóry przy pomocy wody.
- Duration of treatment / exposure:
- 4 godziny
- Observation period:
- Obserwacje i wycena.
Obserwacji skóry dokonano po 1, 24, 48 i 72 godzinach od zakończenia narażania [SPR/T/22].
Stan skóry oceniano według skali punktowej, na podstawie Wytycznej OECD nr 404 / Metody B.4. (Załącznik 6).
Wyniki badania oceniono według Załącznika do Rozporządzenia Ministra Zdrowia z dnia 2 września 2003 r. w sprawie kryteriów i sposobu klasyfikacji substancji i preparatów chemicznych (Dz.U. Nr 171, poz. 1666). - Number of animals:
- 3 szt.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
Na podstawie przeprowadzonego badania i według Załącznika do Rozporządzenia Ministra Zdrowia z dnia 2 września 2003 r. w sprawie kryteriów i sposobu klasyfikacji substancji i preparatów chemicznych (Dz.U. Nr 171 poz. 1666) można stwierdzić,żeZn (II) IDHAnie drażni skóry królików
5.5. Data rozpoczęcia i zakończenia doświadczenia.
Badany materiałnałożono na skórękrólików w dniu: 15.07.2008. (królik nr 1) oraz 22.07.2008. (królik nr 2 i nr 3). Doświadczenie zakończono w dniu 18.07.2008. (królik nr 1), oraz 25.07.2008. (królik nr 2 i nr 3).
6. Wyniki.
6.1. Wyniki działania drażniącego/żrącego.
W trakcie odczytu po 1 godzinie od zakończenia narażania, na skórze w miejscu nałożenia badanego materiału, u królika nr 2 stwierdzono bardzo słaby (ledwo dostrzegalny) rumień. U pozostałych królików zmian patologicznych na skórze nie stwierdzono.
W trakcie odczytu po 24 godzinach od zakończenia narażania, na skórze dwóch królików (królik nr 2 i nr 3) stwierdzono bardzo słaby (ledwo dostrzegalny) rumień. U królika nr 1 nie stwierdzono zmian.
W trakcie odczytu po 48 godzinach od zakończenia narażania, u królików nie stwierdzono jużzmian patologicznych na narażanej skórze.
W trakcie odczytu po 72 godzinach od zakończenia narażania, u królików nie stwierdzono zmian patologicznych na narażanej skórze.
Szczegółowe wyniki badania, w oparciu o skalępunktowąwg Wytycznej OECD nr 404/ Metody B.4., przedstawiono w Tabeli 1 (strona 51).
6.2. Masa ciała zwierząt.
W dniu rozpoczęcia doświadczenia masa ciała królików wynosiła: 3,8 kg (królik nr 1), 3,8 kg (królik nr 2) i 3,7 kg (królik nr 3).
W dniu zakończenia doświadczenia masa ciała królików wynosiła: 3,9 kg (królik nr 1), 3,8 kg (królik nr 2) i 3,7 kg (królik nr 3).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- tetrasodium;2-(1,2-dicarboxylatoethylamino)butanedioate
- Cas Number:
- 144538-83-0
- Molecular formula:
- C8H7NNa4O
- IUPAC Name:
- tetrasodium;2-(1,2-dicarboxylatoethylamino)butanedioate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- lnitial age: approx. 4 months
Body weight at start of study: 2.0 - 2.1 kg
ldentification: by tattooed number assigned by the lohndorf breeding station and continuous number 1 - 3
Duration of adaptation : at least 20 days
Administration route: dermal application to the shaved intact dorsal skin (semi-occlusive procedure)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- aqua ad iniectabilia
- Controls:
- yes
- Amount / concentration applied:
- 500 mg/patch and animal, once epicutaneous
{4000 mg of the test compound were mixed with 1 ml aqua ad iniectabilia, 625 mg of this paste were applied per animal (il, 500 mg test compound/animall) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h
- Number of animals:
- 3 male rabbits
- Details on study design:
- Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.
A dose of 500 mg was applied to the test site (area: approx. 6 cm 2). Pulverised solids were moistened sufficiently with water to ensure good contact with the skin. The test substance was applied to the test site and then covered with a gauze patch. The patch was held in contact with the skin by means of a semi-occlusive dressing for the duration of the exposure period. The surrounding untreated skin served as a control.
Exposure time was four hours. During the exposure the animals were kept in com fortable restrainers.
Examination of the skin: the skin sites were evaluated immediately before the applica tion of the test substance. After the 4-hour exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal.
The evaluation of the skin irritation was based on the grading given in the Appendix 1 to this report.
Based on most recent guidelines the skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.
General criteria: body weight of all animals was measured at the beginning of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg lminodisuccinic acid, sod,um salt IIDS, Na-Salz)/patch and anirnal (semi occlusive condition) showed any substance·related lesions at the examination time points 60 min. 24, 48 and 72 hours after patch removal.
There were no systemie intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- IDS, sodium salt was non-irritating to skin.
- Executive summary:
Test system acute skin irritation, Patch·Test, in rabbits, semi-occlusive, according to EC guideline B.4. and OECD guideline404
Test substance lminodisuccinic acid, sodium salt (IDS.Na·Salz)
Under the present test conditions none of the three rabbits exposed for 4 hours to 500 mg iminodisuccinic acid, sodium salt {IDS, Na-Salz)/patch and animal (semi occlusive condition) showed any substance-related lesions at the exarnination time· points 60 min, 24. 48 and 72 hours after patch removal. Them were no systemic intolerance reactions.
According to the Regulation 1272/2008 and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present testconditions lminodisuccinic acid, sodium salt (IDS, Na-Salzl) was non-irritatingto skin, hence, no labelling is required.
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