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EC number: 476-670-7 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May, 29 - June, 12, 2007
- 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:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Statement of GLP Compliance No G-024 issued by Slovac National Accreditation Service; Statement of GLP Compliance No 4/2006/DPL issued by Bureau for Chemical Substances and Preparations
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 666828-40-6
- Cas Number:
- 666828-40-6
- IUPAC Name:
- 666828-40-6
- Reference substance name:
- Fe(III)IDHA
- IUPAC Name:
- Fe(III)IDHA
- Test material form:
- other: microgranules
- Details on test material:
- - Name of test material (as cited in study report): Fe(III)IDHA
- Substance type: chelate
- Physical state: green microgranules
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Occupational Medicine in Łódz kept in conventional type.
- Age at study initiation: 10-week-old male rats and 11-weekold females
- Weight at study initiation: male rats with the average body weight of 287 g and females with the average body weight of 194 g
- Fasting period before study: no
- Housing:
- Diet (e.g. ad libitum): standard granulated "Murigran" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): tap water
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C;
- Humidity (%): 48 - 80
- Photoperiod (hrs dark / hrs light): artificial, fluorescent lighting: 12 hours light / 12 hours darkness
The animals were kept in cages with plastic bottom and wired lid, with dimensions: (length x width x height) 58 x 37 x 21 cm. Following administration of the test material on animals skin, each one was kept individually per cage. After removal of the test material from animals skin, during the following days of experiment the rats were kept five per cage, each sex separately.
Wooden UV-sterilized shavings were used as a litter. Each cage was equipped with label containing information on name of test material, study code, used dose, start date and planned ending date of the experiment, animal sex and animal numbers.
IN-LIFE DATES: From: To:
The experiment was started on May 29th, 2007 (males and females) and ended on June 12th, 2007.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The day before the test back and sides of animals were shaved with electric razor on skin surface area of about 4 x 6 cm. Only those animals that showed no macroscopically visible irritation or damages of skin were used for the experiments. The animals were not starved prior to the experiment.
The undiluted test material was applied to the dorsal skin of 10 rats (5 males and 5 females) in dose of 2000 mg/kg b.w. The area of skin treated with the test material was about 6 cm2. The test material was applied to gauze patches and then laid on the prepared skin. The gauze patches were covered with PCV foil and elastic bandage was used to make circular protecting band. After 24 hours the band and gauze patches were taken off and the residual test material was removed using water. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Evaluation of general condition of animals, i.e. observation of all animals in regards to mortality and morbidity was conducted twice a day during 14-day observation period. Following administration of the test material, detailed clinical observations were performed in hour intervals during the day of administration (day 0). Since the first till the 14th day of observation period detailed clinical observations were performed once a day.
Body weight of animals was determined individually for each animal directly before administration of the test material (day 0) and then on seventh andfourteenth day - before the finishing of the experiment.
- Necropsy of survivors performed: yes
- Other examinations performed: After opening of thorax and abdomen macroscopic examination of internal organs was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All rats survived the 14-day observation period.
- Clinical signs:
- other: During 14-day experiment period no changes on skin or in behavior of test animals were stated.
- Gross pathology:
- No pathological changes were stated in animals during macroscopic examination.
Any other information on results incl. tables
Chelate with name: Fe (III) IDHA Acute dermal toxicity study for rats – clinical signs – overall list
Dose (mg/kg b.w.) |
Sex |
Day after administration |
No of alive animals |
Rat No |
|
||||
1 |
2 |
3 |
4 |
5 |
|
||||
|
|||||||||
|
|||||||||
2000 |
Males |
0 |
5 |
NC |
NC |
NC |
NC |
NC |
|
1 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
2 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
3 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
4 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
5 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
6 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
7 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
8 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
9 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
10 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
11 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
12 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
13 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
14 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
Females |
0 |
5 |
NC |
NC |
NC |
NC |
NC |
|
|
|
|||||||||
1 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
2 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
3 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
4 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
5 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
6 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
7 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
8 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
9 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
10 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
11 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
12 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
13 |
5 |
NC |
NC |
NC |
NC |
NC |
|
||
14 |
5 |
NC |
NC |
NC |
NC |
NC |
|
NC – no changes
Chelate with name: Fe (III) IDHA Acute dermal toxicity study for rats – body weight of animals (g)
Dose (mg/kg b.w.) |
Sex |
Rat No |
Day |
Difference |
|
||
|
|||||||
0 |
7 |
14 |
14 - 0 |
|
|||
|
|||||||
|
|||||||
|
|
|
|||||
2000 |
Males |
1 |
260 |
281 |
302 |
42 |
|
2 |
299 |
308 |
326 |
27 |
|
||
3 |
285 |
293 |
315 |
30 |
|
||
4 |
300 |
316 |
345 |
45 |
|
||
5 |
293 |
309 |
332 |
39 |
|
||
|
|
|
|
|
|
|
|
|
1 |
191 |
206 |
209 |
18 |
|
|
Females |
|
||||||
2 |
191 |
203 |
215 |
24 |
|
||
3 |
194 |
203 |
211 |
17 |
|
||
4 |
198 |
207 |
216 |
18 |
|
||
5 |
195 |
199 |
218 |
23 |
|
||
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Taking into account the obtained results one may state that the median dermal acute dose (LD50) for Chelate with name: Fe (III) IDHA is higher than 2000 mg/kg b.w.
- Executive summary:
Acute dermal toxicity study of Chelate with name: Fe (III) IDHA for rats was performed according to the OECD Guideline for Testing of Chemicals No 402/ Method B.3 as well as Principles of Good Laboratory Practice (GLP - OECD, 1997). The test material was given to 10 rats (5 males and 5 females) to shaved dorsal skin in single dose of 2000 mg/kg b.w. for 24 hours. During 14-day observation period no changes on skin or in behavior were stated in test animals. All animals survived 14- day experiment period. All animals which were euthanized after 14-day observation period were dissected and studied macroscopically. Macroscopic examination showed no pathological changes in test animals. Taking into account the obtained results one may state that median dermal acute dose (LD50) for Chelate with name: Fe (III) IDHA is higher than 2000 mg/kg b.w.
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