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EC number: 617-909-9 | CAS number: 86702-10-5
- 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
Endpoint summary
Administrative data
Description of key information
Oral LD50 in rat: > 2000 mg/kg bw (OECD 423 and GLPs compliant study)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 November 2015 to 08 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: CY50561001
- Expiration date of the batch: 24/04/2016
- Purity test date: 65.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature 15-25°C, below 70 RH%
- Solubility and stability of the test substance in the solvent/vehicle: soluble in water. Stability not checked
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was freshly formulated at a concentration of 200 mg a.i/mL in the vehicle (distilled water)
- Final dilution of a dissolved solid, stock liquid or gel: 200 mg a.i/mL - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:
- Weight at study initiation: 11 weeks old
- Fasting period before study: On the night before treatment
- Housing: LIGNOCEL ¾ S certified wooden chips (Brandenburg Holzfaserstoffe GmbH & Co. KG, Arkeburger Str. 31, G-49424, Goldenstedt) were available to animals during the study. Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 26, 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 – 22.2°C
- Humidity (%): 35 - 62 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 10 November 2015 To: 25 November 2015 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg a.i/L. Purity conversion has been applied in the study (for this purpose, the 65.4% purity value of the substance was taken into consideration).
- Justification for choice of vehicle:
- Lot/batch no. (if required): 6820914
- Purity: N/A
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual):The test item was freshly formulated at a concentration of 200 mg a.i/mL in the vehicle, in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg bw of Diquat
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter
- Necropsy of survivors performed: Macroscopic examination was performed on all animals. The animals were sacrificed by exsanguination under pentobarbital anaesthesia. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed. Macroscopic abnormalities were recorded. - Statistics:
- N/A
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- Diquat did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Acute oral administration of Diquat did not cause any test item related effect.
- Gross pathology:
- At necropsy, no macroscopic findings were reported at a dose level of 2000 mg/kg bw.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Diquat was found to be above 2000 mg/kg bw in female CRL:(WI) rats. According the GHS criteria, Diquat can be ranked as “Unclassified” for acute oral exposure as no treatment-related mortality or clinical signs were reported at the tested dose of 2000 mg/kg bw.
- Executive summary:
The single-dose oral toxicity of Diquat was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in CRL:(WI) rats.
Two groups of 3 female CRL:(WI) rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in distilled water at a concentration of 200 mg a.i/mL at a dose volume of 10 mL/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and before necropsy. All animals were subjected to a necropsy and a macroscopic examination.
The results of the study were summarized as follows:
Diquat did not cause mortality at a dose level of 2000 mg/kg bw.
Acute oral administration of Diquat did not cause any test item related clinical signs.
There were no effects on body weights or body weight gains that could be attributed to treatment with Diquat.
At necropsy, no macroscopic findings were reported at a dose level of 2000 mg/kg bw.
In conclusion, under the conditions of this study, the acute oral LD50 value of the test item Diquat was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
According to the GHS criteria, Diquat can be ranked as "Unclassified” for acute oral exposure as no treatment-related mortality or clinical signs were reported at the tested dose of 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study fully reliable (GLP and OECD 423 compliant).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study performed according to OECD Test guideline 423 and in compliance with GLP, two groups of 3 female CRL:(WI) rats were treated with the test item at a dose level of 2000 mg/kg bw at a dose volume of 10 mL/kg bw.
Diquat did not cause mortality at a dose level of 2000 mg/kg bw. Acute oral administration of Diquat did not cause any test item related clinical signs up to the end of the 14 -day observation period. There were no effects on body weights or body weight gains that could be attributed to treatment with Diquat.
At necropsy, no macroscopic findings were reported at a dose level of 2000 mg/kg bw.
In conclusion, under the conditions of this study, the acute oral LD50 value of the test item Diquat was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
Justification for classification or non-classification
Under the conditions of this study, the acute oral LD50 value of the test item Diquat was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
According to the GHS criteria, Diquat can be ranked as “Unclassified” for acute oral exposure as no treatment-related mortality or clinical signs were reported at the tested dose of 2000 mg/kg bw.
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