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EC number: 616-995-5 | CAS number: 8018-01-7
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 72-2 (Aquatic Invertebrate Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.010, 0.018, 0.032, 0.056, 0.10, 0.18, 0.32, 0.56 and 10 mg/L
- Sampling method: at 0 and 48 hours samples for analysis were taken
- Sample storage conditions before analysis: not specified - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Source: not reported
- Feeding during test: yes
- Food type: fry fish food and suspension of mixed algae
- Frequency: daily - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 350 mg/L
- Test temperature:
- 21 ± 1 °C
- Nominal and measured concentrations:
- Nominal: 0 (control), 0.010, 0.018, 0.032, 0.056, 0.10, 0.18, 0.32, 0.56 and 10 mg/L,
Measured: 0 (control), 0.0084, 0.011, 0.015, 0.021, 0.029, 0.031, 0.035, 0.067 and 0.20 mg/L - Details on test conditions:
- TEST SYSTEM
- No. of organisms per vessel: 20
OTHER TEST CONDITIONS
- Photoperiod: 16 hours ligth/ 8 hours dark
EFFECT PARAMETERS MEASURED :
immobilisation after 24 and 48 h of exposure - Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 73 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 31 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- - Mortality of control: 0%
- Other adverse effects control: 0%
- Immobilisation of control: 0%
- Abnormal responses: not observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: highest test concentration of nominal 10 mg/L is greater than the solubility limit of the test item of 0.2 mg/L. - Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the test results, the 48-hour LC50 for the water flea (Daphnia magna) was determined to be 73 µg/L based on measured concentrations. The no observed effect concentration (NOEC) was estimated to be 31 µg/L based on measured concentrations. The study is considered as key information.
- Executive summary:
The acute toxicity of the test item to water flea (Daphnia magna) was determined in a 48-hour test under GLP-conditions, according to the OECD Guideline for Testing of Chemicals No. 202 and EPA Pesticide Assessment Guideline 72-2. In this static test, Daphnia magna were exposed to an aqueous test medium containing the test item at the nominal concentrations of 0.010, 0.018, 0.032, 0.056, 0.10, 0.18, 0.32, 0.56 and 10 mg a.s./L, which corresponds to 0.0084, 0.011, 0.015, 0.021, 0.029, 0.031, 0.035, 0.067 and 0.20 mg/L based on measured concentration. The 48-hour NOEC of the test item to Daphnia magna was determined to be 31 µg a.s./L and the 48-hour LC50 was determined to be 73 µg a.s./L based on measured concentrations. All validity criteria were fulfilled.
Reference
Table 1: Immobile Daphnia magna in percent after exposure of Mancozeb concentrations (measured)
| Measured test item concentrations [µg/L] | |||||||||
| 0 | 8.4 | 11 | 15 | 21 | 29 | 31 | 35 | 67 | 200 |
Time [h] | % of immobile Daphnia magna | |||||||||
24 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 25 | 75 |
48 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 15 | 55 | 100 |
Description of key information
In a static acute toxicity test to Daphnia magna according to OECD TG 202 an EC50 of 73 µg a.s./L (measured) was determined. By applying a geomean approach taking into account additional guideline studies with Daphnia magna as supportive information an overall LC50 of 120.83 µg a.s./L was derived. The LC50 of 120.83 µg a.s./L is considered as key value for the risk assessment.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 120.83 µg/L
Additional information
The short-term toxicity of the active substance Mancozeb (purity > 90%) as well as of the preparations Pennozeb 80 WP (Mancozeb: 82.0%) and Sancozeb 800 WP (Mancozeb: 80%) to aquatic invertebrates was assessed in several guideline studies. The most reliable study (Douglas et al., 1988, classified Klimish 1) is considered as key information. However, to reflect the range of available results on short-term toxicity to aquatic invertebrates and, further, to comply with the hazard assessment applied under Regulation (EU) No 1107/2009 concerning the placing of plant protection products on the market and repealing, a geomean approach is followed.
Key study
Short-term toxicity to Daphnia magna in a static system (OECD 202) ref. Douglas et al. 1988 (cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 8.2.5/01)
The acute toxicity of the test item to water flea (Daphnia magna) was determined in a 48-hour test under GLP-conditions, according to the OECD Guideline for Testing of Chemicals No. 202. In this static test, Daphnia magna were exposed to an aqueous test medium containing the test item at the nominal concentrations of 0.010, 0.018, 0.032, 0.056, 0.10, 0.18, 0.32, 0.56 and 10 mg a.s./L. The 48-hour NOEC of the test item to Daphnia magna was determined to be 31 µg a.s./L and the 48-hour LC50 was determined to be 73 µg a.s./L based on measured concentrations. All validity criteria were fulfilled.
Supporting information considered for geometric mean calculation
Additional studies testing the acute toxicity of the test item to aquatic invertebrates were conducted and used as supporting information to cover the endpoint and for the geomean estimation, which is used for the risk assessment. However, since the other Daphnia magna endpoints are greater than the limit of solubility of the test item of 200 µg a.s./L, it was agreed in an expert meeting that the value of the limit of solubility will be used in the calculation of the geomean. As these limit of solubility values are technically extrapolations, it was decided that they should not be included in the calculation more than once.
Table 1: Effect endpoints for the calculation of an overall geomean for short-term toxicity to aquatic invertebrates
Reference | Species | Endpoint [µg a.s./L] | Geomean [µg a.s./L] |
Douglas et al. (1988) | D. magna | 73 | 120.83 |
Brouwers (1995) Wüthrich (1993b) | D. magna | 200* | |
* Limit of solubility of Mancozeb as a substitute for the measured endpoints of 900 µg a.s./L (Brouwers, 1995) and 390 µg a.s./L (Wüthrich, 1993b) |
Short-term toxicity to Daphnia magna in a static system (OECD 202) (ref. Brouwers, 1995) (cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 10.2.1/02))
This study was conducted under static conditions following the OECD guideline 202 under GLP with the product Sancozeb 800 WP (Mancozeb: 80%). The nominal test concentrations were 0.1, 0.2, 0.4, 0.8 and 1.6 mg product/L. Analytical measurements of the test item showed that the recovery was in the range of 80 – 120% of nominal. The No-Observed-Effect Concentration (NOEC) established during this study was 0.2 mg a.s./L and the 48-hour LC50 was determined to be 0.9 mg/L based on nominal concentrations. All validity criteria were fulfilled.
Short-term toxicity to Daphnia magna in a static system (OECD 202) (ref. Wüthrich, 1993) (cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 10.1.2./03))
This study was conducted under static conditions following the OECD guideline 202 and under GLP with the product Pennozeb 80 WP (Mancozeb: 82%). The nominal test concentrations were 0.063, 0.125, 0.25, 0.5 and 1 mg product/L. Analytical measurements of the test item showed that the recovery was in the range of 80 – 120% of nominal. The 48-hour LC50 was determined to be 0.47 mg product/L, which corresponds to 0.39 mg a.s./L based on nominal concentrations. All validity criteria were fulfilled.
In accordance with Regulation (EU) No 1107/2009 the key study and the above mentioned supporting studies were peer reviewed by rapporteur member states and have been proven to be valid by the EFSA.
For details on test conditions and findings please refer to the disseminated EFSA Conclusion on the active substance Mancozeb (Peer review of the pesticide risk assessment of the active substance mancozeb; European Food Safety Authority (EFSA), approved 12 June 2019, doi:10.2903/ j.efsa.2019.5755).
Conclusion
Experimental information on the short-term toxicity of the active substance Mancozeb as well of the preparations Pennozep 80 WP (Mancozeb: 82.0%) and Sancozeb 800 WP (Mancozeb: 80%) is available. In a static Daphnia magna, Acute Toxicity Test according to OECD TG 202 a 48-hour LC50 of 73 μg a.s./L (measured) was determined (Douglas et al., 1988). This value is supported by results of additional GLP-compliant guideline studies performed with Daphnia magna (> 200 µg a.s./L, the solubility limit of test item). By applying a geomean approach an overall LC50 of 120.83 µg a.s./L was derived and is considered for the risk assessment. The provided information is regarded reliable and sufficient to cover the data requirements according to REACH Annex VIII, section 9.1.3.
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