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EC number: 262-810-2 | CAS number: 61477-95-0
- 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:
- 18.10.2018-07.12.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Monalazone disodium
- EC Number:
- 262-810-2
- EC Name:
- Monalazone disodium
- Cas Number:
- 61477-95-0
- Molecular formula:
- C7H4ClNO4S.2Na
- IUPAC Name:
- disodium 4-[(chloroazanidyl)sulfonyl]benzoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Test Item Name : Monalazone Disodium
CAS No. : Proprietary
Molecular Formula : C7H4ClNNa2O4S
Molecular Weight : 279.602 g/mol
Purity as per COA : >99% excluding water
Physical Appearance : White or Off white powder or crystals
Aqueous pH : 8-10
Lot No. : 72617S
Manufactured Date : 26-07-2017
Expiry date : 01-02-2019
Recommended Storage : Ambient (+18 to +36oC)
Photosensitive : Yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Invivo Biosciences, Shed No. 23, Katha No.3169, Assessment No. 154, Kodigehalli Village, Magadi Road, Bangalore-560091, Karnataka, India
- Females (if applicable) nulliparous and non-pregnant
- Age at study initiation: 8 to 9 Weeks
- Weight at study initiation: 165.6 to 192.5 g
- Fasting period before study: overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item.
- Housing:Rats were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage once a week. Bedding: steam sterilized
- Diet: Ad libitum. Hypro Rat & Mice pellet feed, manufactured by Krishna Valley Agrotech LLP, MIDC Kupwad block, Sangli, Maharashtra, was provided to animals.
- Water: Ad libitum. Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: After physical examination for good health and suitability for experiment, the animals were acclimatized 8 days for G1-FTS, 10 days for G1-STS, 12 days for G2-FTS & 12 days for G2-STS, before treatment. Animals were observed once daily during acclimatization period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25°C
- Humidity (%): 64 to 68%
- Air changes (per hr): 13.5 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: The test item was checked for solubility / suspendability with Milli-Q water Test item formed suspension in Milli-Q water. Hence Milli-Q water was selected as vehicle and was used to prepare the dose formulations.
- The details of dose formulation
Dose (mg/kg) Concentration(mg/mL) Volume of test item
Suspension (mL) Test item quantity (g)
300 30 20 0.6
300 30 20 0.6
2000 200 15 3.0
2000 200 15 3.0
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. As there was no available toxicology information about this test item, Hence, the study was initiated with the starting dose of 300 mg/kg body weight - Doses:
- 300 and 2000 (highest dose level) mg/kg body weight
- No. of animals per sex per dose:
- Group Dose
(mg/kg) No. of Rats Sex
G1 (FTS) 300 3 Female
G1 (STS) 300 3 Female
G2 (FTS) 2000 3 Female
G2 (STS) 2000 3 Female - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15. The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes. Microscopic examination was not carried out as no gross pathological changes were observed.
- Other examinations performed: clinical signs, body weight,gross pathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- other: G1 - [300 mg/kg body weight - Treatment (FTS & STS)]: There were no clinical signs observed and there was no mortality. G2 - [2000 mg/kg body weight - Treatment (FTS & STS)]: G2-FTS: there were no clinical signs and pre-terminal deaths G2-STS: Clinical
- Gross pathology:
- There were no gross pathological changes at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Monalazone Disodium in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight.
- Executive summary:
To determine the acute toxicity, a stepwise procedure was employed with the use of three animals of a single sex (female), at each step. Sufficient information was obtained on the acute toxicity of the test item for its classification. The test item was administered orally to a group of experimental animals at one of the defined doses (i.e. 300 mg/kg body weight) as a first step (G1-FTS). All the rats survived at this step, the test was continued with the same dose of 300 mg/kg body weight (G1-STS), all the rats survived at this step. The dosing was continued with the next higher dose of 2000 mg/kg body weight (G2-FTS). All the rats survived at this step, the test was continued with three additional animals with the same dose of 2000 mg/kg body weight (G2-STS). 2 out of 3 rats survived, hence testing was stopped and the LD50cut-off value was arrived.
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