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Diss Factsheets
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EC number: 241-221-4 | CAS number: 17169-60-7
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2019-07-26 to 2019-10-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- Federal Law No. 61–FZ “On the Circulation of Medicinal Products” of 12 April 2010 (as amended);Federal Law No. 323–FZ “On the Basics of Health Protection of the Citizens in the Russian Federation” of 21 November 2011 (as amended)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Diiron tris(sulphate)
- EC Number:
- 233-072-9
- EC Name:
- Diiron tris(sulphate)
- Cas Number:
- 10028-22-5
- Molecular formula:
- Fe.3/2H2O4S
- IUPAC Name:
- diiron tris(sulphate)
- Reference substance name:
- DL-lysine
- EC Number:
- 200-740-6
- EC Name:
- DL-lysine
- Cas Number:
- 70-54-2
- Molecular formula:
- C6H14N2O2
- IUPAC Name:
- DL-Lysine
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NPO House of Pharmacy (inhouse bred)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Fasting period before study: 16h
- Housing: individually in standard transparent plastic cages. Wood pellets were used as bedding.
- Diet (e.g. ad libitum): Feed for laboratory animals PK-120-1 prepared in accordance with GOST R50258-92 "Compound Feeds for Laboratory Animals. Specifications” was given ad libitum
- Water (e.g. ad libitum): purified water normalized in respect of organoleptic properties, pH, solids, reducing substances, carbon dioxide, nitrates and nitrites, ammonia, chlorides, sulphates, calcium and heavy metals in accordance with SanPiN 2.1.4.1074-01 "Drinking Water. Hygienic Requirements for the Quality of Water from Centralized Drinking Water Supply Systems. Quality Control". Water in standard drinking bowls with steel nose caps was given ad libitum.
- Acclimation period: 5 days
- Method of randomisation in assigning animals to test and control groups: Randomization was not expected in this study, since dosing occurred in stages and individually. The main criterion for including an animal in the experiment was its body weight.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:
No. 2.0-31.05/19 of 31 May 2019
No. 2.0-30.06/19 of 01 July 2019
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% starch solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Before administration, suspensions of the test article was prepared with concentrations of ≈ 29.2 mg/mL for 175 mg/kg, ≈ 91.7 mg/ml for 550 mg/kg and 333.3 mg/ml for 2000 mg/kg.
- Amount of vehicle (if gavage): 1.5 mL per 250g rat
- Lot/batch no. (if required): М-4.38/19
MAXIMUM DOSE VOLUME APPLIED: 333.3 mg/mL
CLASS METHOD
- Rationale for the selection of the starting dose:since the test article is presumably a low toxicity substance, 175 mg/kg was selected as the starting dose for a single intragastric administration to one male and one female rat. - Doses:
- 175, 550, 2000 mg/kg bw
- No. of animals per sex per dose:
- 175 mg/kg bw: 1 animal; 550 mg/kg bw: 1 animal; 2000 mg/kg bw 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On day 1, 2, 7 and 15
- Necropsy of survivors performed: yes
- Clinical signs: daily
- Other examinations performed: other:Clinical examination on day 2, 7, 14 and local tolerance evaluation on day 15 - Statistics:
- Calculation of LD50 with confidence intervals was performed using the AOT 425 StatPgm program (Westat, USA).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were observed
- Clinical signs:
- other: No clinical signs of intoxication were observed.
- Gross pathology:
- No gross abnormalities in the internal organs were identified at the scheduled necropsy in experimental animals treated with a single intragastric dose
- Other findings:
- The test article, ferrous monolysinate sulfate, at 175 mg/kg (in 1 male) and at 2000 mg/kg (in 1 male and 1 female) following single-dose intragastric administration had a moderate local irritant effect, which was manifested as catarrhal gastritis detected by a histological examination of the stomach tissues.
Applicant's summary and conclusion
- Interpretation of results:
- other: According to Regulation (EU) No. 1272/2008 (CLP) the substance does not need to be classified as acutely toxic by oral route
- Conclusions:
- LD50 for ferrous monolysinate sulfate is > 2000 mg/kg following single-dose intragastric administration to male and female rats. Ferrous monolysinate sulfate can be classified as toxicity category 5 according to the international GHS classification.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 425, fasted, 8-12 weeks old Sprague Dawley strain rats were given a single oral dose of ferrous monolysinate sulfate in 1% starch solution by gavage at a dose of 175 mg/kg bw: 1 animal; 550 mg/kg bw: 1 animal; 2000 mg/kg bw 3 animals and were observed for 14 days.
None of the animals died. No clinical signs were observed in the treated animals. No gross abnormalities in the internal organs were identified at the scheduled necropsy in experimental animals treated with a single intragastric dose. The test article, at 175 mg/kg (in 1 male) and at 2000 mg/kg (in 1 male and 1 female) following single-dose intragastric administration had a moderate local irritant effect, which was manifested as catarrhal gastritis detected by a histological examination of the stomach tissues.
Oral LD50 (rat, females/males) > 2000 mg/kg bw
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