mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

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.

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

 

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.

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.