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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Length at study initiation: mean standard length of 3.1 cm
- Weight at study initiation: mean weight 0.69 g

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

350 mg/L

Test temperature:

21 ± 1 °C

Nominal and measured concentrations:

0.10, 0.18, 0.32, 0.56 and 1.0 mg/L (nominal)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

74 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The 96 h LC50 is 0.074 mg a.i./L (measured concentration).
The NOEL can be determined at 0.041 mg/L (measured concentration).

- Other biological observations: lethargy, increased pigmentation, moribundy and fish lying on the bottom
- Mortality of control: no
- Other adverse effects control: no

Validity criteria fulfilled:

yes

Conclusions:

Based on the test results, the 96-hour LC50 for rainbow trout (Oncorhynchus mykiss) was determined to be 74 µg/L based on mean measured concentrations. The no observed effect concentration (NOEC) was estimated to be 41 µg/L based on mean measured concentrations.

Executive summary:

The acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss) was determined in a 96-hour under GLP-conditions, according to the OECD Guideline for Testing of Chemicals No. 203 (1992). In this semi-static test, rainbow trout (Oncorhynchus mykiss) were exposed to an aqueous test medium containing the test item at the nominal concentrations of 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L. The 96-hour NOEC of the test item to rainbow trout was determined to be 41 µg/L and the 96-hour LC₅₀ was determined to be 74 µg/L based on mean measured concentrations. All validity criteria were fulfilled.

Description of key information

In a semi-static Fish, Acute Toxicity Test according to OECD TG 203 with O.mykiss a 96-hour LC50 of 74 μg a.s./L (mean measured) was determined. By applying a geomean approach taking into account four additional guideline studies as supportive information an overall LC50 of 118.1 µg a.s./L was derived. The LC50 of 118.1 µg a.s./L is considered as key value for the risk assessment.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

118.1 µg/L

Additional information

The short-term toxicity of the active substance Mancozeb (purity > 90%) as well as of the preparation Pennozep 80 WP (Mancozeb: 82.0%) to fish was assessed in several guideline studies with different test species. The most reliable study (Douglas et al., 1997, classified Klimish 1) is considered as key information. However, to reflect the range of available results on short-term toxicity to fish 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 rainbow trout (Oncorhynchus mykiss) in a semi-static system (OECD 203) ref. Douglas et al. 1997 (cross reference: 8.2.1/01)

The acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss) was determined in a 96-hour test under GLP-conditions, according to the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992). In this semi-static test, rainbow trout (Oncorhynchus mykiss) were exposed to an aqueous test medium containing the test item at the nominal concentrations of 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L. The 96-hour NOEC of the test item to rainbow trout was determined to be 41 µg/L and the 96-hour LC₅₀ was determined to be 74 µg/L based on measured concentrations. All validity criteria were fulfilled.

 

 

Supporting information considered for geometric mean calculation

Four additional studies testing the acute toxicity of the test item to fish were conducted and used as supporting information to cover the endpoint and for the geomean estimation, which is used for the risk assessment.

 

Short-term toxicity to rainbow trout (Oncorhynchus mykiss) in semi-static system (Licata-Messana 1997 (Doc. No. 821-002, cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 8.2.1.1))

This study was conducted under semi-static conditions following the OECD guideline 203 (1992) under GLP. The nominal test concentrations were 0.2, 0.4, 1.0, 2.1 and 4.7 mg/L. The No-Observed-Effect Concentration (NOEC) established during this study was 49 µg/L and the 96-hour LC₅₀ was determined to be 88 µg/L based on measured concentrations (geometric mean values). All validity criteria were fulfilled.

 

Short-term toxicity to rainbow trout (Oncorhynchus mykiss) in flow-through system (Wüthrich 1993 (Doc. No. 821-016, cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 10.2.1/01))

This study was conducted under flow-through conditions following the OECD guideline 203 (1992) under GLP with the product Pennozeb 80 WP (Mancozeb: 82 %). The nominal test concentrations were 0.1, 0.17, 0.31, 0.56 and 1.0 mg product/L, which corresponds to 0.09, 0.15, 0.27, 0.49 and 0.88 mg product/L of mean measured concentration. The No-Observed-Effect Concentration (NOEC) established during this study was 0.09 mg product/L, which corresponds to 75 µg a.s./L and the 96-hour LC₅₀ was determined to be 0.18 mg product/L, which corresponds to 150 µg a.s./L, based on mean measured concentrations. All validity criteria were fulfilled.

Short-term toxicity to bluegill (Lepomis macrochirus) in a semi-static system (Douglas et al. 1997, cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 8.2.1/02)

This study was conducted under semi-static conditions following the OECD guideline 203 (1992) under GLP. The nominal test concentrations were 0.056, 0.10, 0.18, 0.32 and 0.56 mg/L. The No-Observed-Effect Concentration (NOEC) established during this study was 56 µg/L and the 96-hour LC₅₀ was determined to be 83 µg/L based on mean measured concentrations. All validity criteria were fulfilled.

Short-term toxicity to carp (Cyprinus carpio) in a flow-through system (Wüthrich 1993 (Do. No. 821-014, cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 10.2.1/02))

This study was conducted under flow-through conditions following the OECD guideline 203 (1992) under GLP with the product Pennozeb 80 WP (Mancozeb: 82 %). The nominal test concentrations were 0.48, 0.86, 1.54, 2.78 and 5 mg/L, which corresponds to 0.42, 0.75, 1.34, 2.41 and 4.3 mg/L of mean measured concentrations. The No-Observed-Effect Concentration (NOEC) established during this study was 1.34 mg product/L and the 96-hour LC₅₀ was reported as a range between 2.24 and 4.3 mg product/L based on mean measured concentrations. Since no LC₅₀ estimation was presented in the report the lowest value of 2.24 mg product/L was chosen to represent the LC₅₀ as a conservative approach. Based on the a.s. content of 82 % the LC₅₀ value is 1.84 mg a.s./L.

 

Table 1: Effect endpoints for the calculation of an overall geomean for short-term toxicity to fish

Species	Endpoint [µg a.s./L]	Geomean species [µg a.s./L]	Overall Geomean [µg a.s./L]
O. mykiss	74	99.22	118.1
O. mykiss	88
O. mykiss	150
L. macrochirus	83	-
C. carpio	200*	-

* solubility limit of mancozeb is used as the endpoint of 1840 µg/L was greater than this value

 

In accordance with Regulation (EU) No 1107/2009 the key study and all 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 Mancozep (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 preparation Pennozep 80 WP (Mancozeb: 82.0%) is available. In a semi-static Fish, Acute Toxicity Test according to OECD TG 203 with O.mykiss a 96-hour LC50 of 74 μg a.s./L (mean measured) was determined (Douglas et al., 1997). This value is supported by results of four additional GLP-compliant guideline studies performed with Oncorhynchus mykiss, Lepomis macrochirus and Cyprinus carpio (Endpoint ranging between 83 and 200 µg a.s./L). By applying a geomean approach an overall LC50 of 118.1 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.