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Diss Factsheets
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EC number: 217-615-7 | CAS number: 1910-42-5
- 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
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 Jun 2005 to 28 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Commission Directive 92/69/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm Laboratories Limited, Shardlow, Derbyshire, DE72 2GD, UK
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Paraquat-dichloride
- EC Number:
- 217-615-7
- EC Name:
- Paraquat-dichloride
- Cas Number:
- 1910-42-5
- Molecular formula:
- C12H14N2.2Cl
- IUPAC Name:
- 1,1’-dimethyl-4,4’-bipyridyldiylium dichloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD (Crl: CD (SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g, weight variations per sex < 20%
- Housing: the animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually throughout the study.
- Diet: ad libitum to Certified Rat and Mouse Diet (Code 5LF2)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: shorn skin on the back and flanks of the animals
- % coverage: 10 (total body surface area)
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: 3% Teepol followed by warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant volume or concentration used: yes (1.77 mL/kg undiluted test substance) - Duration of exposure:
- 24 hours
- Doses:
- Dose level 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: signs of toxicity: ½, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Body weight: individual body weights were recorded prior to application of the test material on day 0 (defined as day before exposure) and on days 7 and 14.
- Necropsy of survivors: At necropsy (after cervical dislocation) external examination and opening of the abdominal and thoracic cavities was performed.
- Other examinations performed: After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize. - Statistics:
- Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: original value presented in study
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 922 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: recalculated value, expressed as pure substance, see ‘any other information on results incl. tables’ for respective calculation
- Mortality:
- No mortality observed
- Clinical signs:
- other: No signs of systemic toxicity
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- - Dermal Reactions: Very slight to well-defined erythema was noted at the treatment sites of three males and all females. Other signs of dermal irritation noted were haemorrhage of dermal capillaries, crust formation, small superficial scattered scabs and glossy skin. Skin reactions prevented evaluation of erythema and oedema at the treatment sites of two females during the study.
Any other information on results incl. tables
Calculation of key result
The doses of the test substance were expressed in technical paraquat dichloride, which relates to an aqueous solution of the registered substance. The key effect levels are calculated by correction for the amount of water: 0.461x 2000 mg paraquat dichloride technical material / kg bw = 922 mg pure paraquat dichloride / kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 for pure test substance (recalculated value) was determined to be >922 mg/kg body weight for males/females. This value is corresponding to a original value of > 2000 mg/kg bw technical solution.
- Executive summary:
In this GLP compliance study performed according to OECD guideline 402, 5 female and 5 male rats (Sprague-Dawley CD) were exposed to the test substance at a concentration of 2000 mg/kg body weight for 24 hours under semi-occlusive conditions. After this period the test substance was removed with cotton wool moistened with 3% Teepol followed by warm water, and the animals were observed for a period of 14 days. No mortality and clinical signs were observed. Animals showed expected weight gains during the study and no abnormalities were observed at autopsy. Some mild skin reactions were noted including Very slight to well-defined erythema and haemorrhage of dermal capillaries, crust formation, small superficial scattered scabs and glossy skin. The LD50 was determined to be >2000 mg/kg body weight for males, females and sexes combined, which corresponds to a recalculated value of 922 mg pure substance/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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