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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity: short-term oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7800
- Version / remarks:
- (1998)
- Deviations:
- yes
- GLP compliance:
- yes
- Limit test:
- no
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
1
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- original value (cation) presented in study.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 138.1 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- recalculated value, expressed as pure test substance, see ‘any other information on results incl. tables’ for respective calculation
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Mean test substance consumption in the 0, 25, 75, and 100 ppm groups was 0, 6.9, 19.9, and 27.3 mg test substance/kg bw/day, respectively, over the entire 28-day study. All animals survived to the scheduled necropsy, except for a 75 ppm animal that escaped during the study which was euthanized and discarded. There were no treatment-related clinical observations or effects on body weights, food consumption, organ weights, or macroscopic findings for either the AFC or NKC assay animals. In the AFC assay, there were no effects attributed to the test substance on the specific activity or total activity of splenic IgM AFC to the T cell-dependent antigen sRBC. For the AFC positive control group (CPS), statistically significantly lower spleen weight, spleen cell numbers (63%), specific activity (100%), and total spleen activity (100%) of IgM antibody-forming cells were noted when compared to the vehicle control group. These effects on spleen weights, spleen cell numbers, and spleen activity (i.e., number of specific IgM antibody-forming cells directed towards the sRBC antigen) were consistent with the known immunosuppressant effects of CPS and validated the functionality of the AFC assay. In the NKC assay, there were no effects attributed to the test substance on NKC activity. For the NKC positive control group (anti asialo GM1), statistically significantly lower NKC activity at all effector:target ratios was noted when compared to the vehicle control group. This effect was consistent with the known effects of anti asialo GM1 on NKC activity, which validated the functionality of the NKC assay.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, treatment of female B6C3F1 mice with test substance on a continuous basis in the diet for a minimum of 28 consecutive days at 25, 75, and 100 ppm resulted in no suppression of the humoral (AFC) or innate (NKC) components of the immune system. The no-observed-effect level (NOEL) for both the AFC assay (humoral immunity) and the NKC assay (innate immunity) was 100 ppm (equivalent to approximately 27.3 mg test substance/kg body weight/day), the highest dose examined.
- Executive summary:
The test substance was offered ad libitum in the diet for a minimum of 28 consecutive days to female B6C3F1 mice in Groups 2, 3, and 4 at dietary concentrations of 25, 75, and 100 ppm, respectively. Ten mice/group (Subset A) were used for the splenic Antibody-Forming Cell (AFC) assay and 10 mice/group (Subset B) were used for the Natural Killer Cell (NKC) assay. Mice in the AFC positive control group (Group 5A) were administered the positive control substance, cyclophosphamide (CPS) via intraperitoneal injection (50 mg/kg/day) once daily for 4 consecutive days (study days 24 through 27). All AFC group mice (Groups 1A-5A) were immunized with an intravenous or intraperitoneal injection of sheep red blood cells (sRBC) on study day 24, approximately 96 hours prior to the scheduled necropsy. Mice in the NKC positive control group (Group 6B) were administered the positive control substance (anti asialo GM1) via a single intravenous injection (0.2 mL/animal) on study day 27, approximately 24 hours prior to the scheduled necropsy. The concurrent control groups (Groups 1A and 1B) and the positive control groups (Groups 5A and 6B) were offered the basal diet on a regimen comparable to the test substance-treated groups. All animals were euthanized on study day 28. All animals were observed twice daily for mortality and morbidity. Clinical examinations were performed once daily for all animals. Detailed physical examinations were performed once weekly and on the day of the scheduled necropsy. Individual body weights were recorded twice weekly and food consumption was recorded approximately weekly. Complete necropsies were conducted on all animals at the scheduled necropsy. The kidney, lung, and spleen were weighed from all AFC- and NKC-designated animals at the scheduled necropsy. In addition, the thymus was weighed from all NKC-designated animals. Spleens were placed in Earle’s balanced salt solution/HEPES buffer and shipped to the immunological laboratory. After arrival at the immunological laboratory, spleen cell suspensions were prepared, spleen cell counts were performed, and the number of specific IgM antibody-forming cells directed towards the sRBC antigen were determined for the AFC-designated animals to measure the humoral immune response. In addition, immunological laboratory personnel prepared the spleens from the NKC-designated animals to measure innate immunity using the NKC assay.
Mean test substance consumption in the 0, 25, 75, and 100 ppm groups was 0, 6.9, 19.9, and 27.3 mg test substance/kg body weight/day, respectively, over the entire 28-day study. All animals survived to the scheduled necropsy, except for a 75 ppm animal that escaped during the study which was euthanized and discarded. There were no treatment-related clinical observations or effects on body weights, food consumption, organ weights, or macroscopic findings for either the AFC or NKC assay animals. In the AFC assay, there were no effects attributed to the test substance on the specific activity or total activity of splenic IgM AFC to the T cell-dependent antigen sRBC. For the AFC positive control group (CPS), statistically significantly lower spleen weight, spleen cell numbers (63%), specific activity (100%), and total spleen activity (100%) of IgM antibody-forming cells were noted when compared to the vehicle control group. These effects on spleen weights, spleen cell numbers, and spleen activity (i.e., number of specific IgM antibody-forming cells directed towards the sRBC antigen) were consistent with the known immunosuppressant effects of CPS and validated the functionality of the AFC assay. In the NKC assay, there were no effects attributed to the test substance on NKC activity. For the NKC positive control group (anti asialo GM1), statistically significantly lower NKC activity at all effector:target ratios was noted when compared to the vehicle control group. This effect was consistent with the known effects of anti asialo GM1 on NKC activity, which validated the functionality of the NKC assay.
In conclusion, the NOAEL for both the AFC assay (humoral immunity) and the NKC assay (innate immunity) was 100 ppm (equivalent to approximately 27.3 mg test substance/kg bw/day), the highest dose examined.
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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