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EC number: 238-173-1 | CAS number: 14281-83-5
- 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:
- key study
- Study period:
- 2019-08-07 to 2019-09-24
- 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:
- Bis(glycinato-N,O)zinc
- EC Number:
- 238-173-1
- EC Name:
- Bis(glycinato-N,O)zinc
- Cas Number:
- 14281-83-5
- Molecular formula:
- C4H8N2O4Zn
- IUPAC Name:
- Zinc bis(aminoacetate)
- Test material form:
- solid
- Details on test material:
- Substance name: Zink bisglycinate
Chemical Name(s): Zinc bisglycinate (monohydrate)
CAS number: 14281‐83‐5
Chemical formula: C4H10N2O5Zn
Molecular weight: 231.51 g/mol
Storage: stored in a cool and dry place in original packaging
Physical state (20°C): solid
Odour: characteristic, slightly metallic
Colour: white
Constituent 1
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-3.38/19
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: 4 animal; 2000 mg/kg bw 6 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:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- > 864.4 - < 4 210
- Mortality:
- Following administration of the test article at 2000 mg/kg, 4 male and 4 female rats died. Death was recorded 48 hours after the administration in 58% of animals (4 males and 3 females). Only in one female, death was recorded 2 hours after administration. The immediate cause of death of all animals was acute heart failure.
- Clinical signs:
- other: Clinical signs of intoxication were recorded in animals treated with a single intragastric dose of Plexomin® Zn 2000 mg/kg, and which were manifested as dyspnoea and wheezing, depressed behaviour with decreased response to external stimuli, ruffled fur an
- Gross pathology:
- No gross abnormalities in the internal organs were identified at the scheduled necropsy in experimental animals treated with a single intragastric dose, however, during unscheduled necropsy, foci of oedema, emphysema and haemorrhagic impregnation of lung tissue, venous congestion of internal organs, as well as mild and moderate congestion of the brain vessels were found in all animal bodies. The immediate cause of death of the animals was acute heart failure.
- Other findings:
- The test article Plexomin® Zn following a single-dose intragastric administration had a moderate local irritant effect, which was manifested as catarrhal gastritis in animals when administered at doses of 175 mg/kg (in 1 female) and 550 mg/kg (in 1 male) and as a film of the test article on the gastric mucosa at 2000 mg/kg. The abnormalities identified in the animals that received the test drug at 2000 mg/kg were reversible.
Any other information on results incl. tables
A total of 4 male and 4 female rats died. Animals Nos. 3, 7, 9, 11, 18, 22, 24 and 26 treated with the test article, Plexomin®Zn 2000 mg/kg, died.
The bodies of all animals that died during the study were subjected to a necropsy and gross examination.
Table 1: Incidence of abnormalities according to the necropsy results of rats treated with the test article (number of animals with identified abnormality/total number of animals)
Organs |
Abnormalities identified |
Plexomin®Zn feed additive (Phytobiotics Futterzusatzstoffe GmbH, Germany) |
|
2000 mg/kg |
|||
males |
females |
||
Lungs |
Foci of emphysema, oedema and haemorrhagic impregnation of the tissue |
4/4 |
4/4 |
Internal organs |
Venous congestion |
4/4 |
4/4 |
Brain |
Oedema and vascular congestion |
4/4 |
4/4 |
The necropsy of animals subjected to a scheduled euthanasia did not find any abnormalities in the internal organs following single intragastric doses of the test article, Plexomin®Zn of 175 mg/kg, 550 mg/kg and 2000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 value for the test item is >300 and < 2000 mg/kg following single-dose intragastric administration to male and female rats. The test item can be classified as toxicity category 4 according to the international GHS classification.
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 425, groups of male and female Sprague-Dawley rats, 8-12 weeks old were given a single oral dose of bis(glycinato-N,O)zinc (% a.i.) in 1% starch solution at doses of 175, 550, or 2000 mg/kg bw and observed for 15 days.
Oral LD50 Combined [males/females]= >300 and <2000 mg/kg bw (95% C.I. 864.4–4210 mg/kg).
Bis(glycinato-N,O)zincis of low toxicity based on the LD50 in both female and male rats.
The first symptoms were observed 5 minutes after administration in 67% of male and female rats that received the test item at 2000 mg/kg. The toxic effect was manifested as dyspnoea and wheezing, depressed behaviour. Ruffled fur and decreased response to picking up and sound stimuli (a clap) were noted in these animals 30 minutes after administration. Forced lying on the stomachs was also noted in one male and female. The female rat developed diarrhoea 30 minutes after administration. Another female rat treated with the test substance at 2000 mg/kg developed ataxia 3 hours after administration, which was manifested as incoordination and bouncing when moving. Symptoms of intoxication persisted in animals until death, which was recorded in 58% of animals 48 hours after administration. Only in one female, death was recorded 2 hours after administration. The immediate cause of death of all animals was acute heart failure. The animals that received the test substance at doses of 175 mg/kg and 550 mg/kg exhibited no symptoms of intoxication.
In two males and females which received the test item at 2000 mg/kg, signs of intoxication were observed 1 to 2 hours after administration, which were manifested as depressed behaviour and ruffled fur. Also, decreased muscle tone was recorded in another female 2 hours after administration. Symptoms of intoxication were reversible and animal condition improved 24 hours after administration. No changes in body weight gain or body weights were observed in all animals. The data obtained allow concluding that the NOAEL for bis(glycinato-N,O)zinc is < 175 mg/kg following single-dose intragastric administration to rats.
Based on these results, bis(glycinato-N,O)zinc is classified according to the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as Category 4 'Harmful if swallowed' with respect to acute oral toxicity.
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