Ziram

Toxicity to terrestrial arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to terrestrial arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 January 1989 - 12 September 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Qualifier:

according to guideline

Guideline:

other: Working Document 7/3 of the United Kingdom Control of Pesticides Regulations, 1986

GLP compliance:

yes

Application method:

other: contact and oral

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

Solution prepared in dimethylsulphoxide (DMSO)

Test organisms (species):

Apis mellifera

Animal group:

Hymenoptera (honeybees)

Details on test organisms:

TEST ORGANISM
- Common name: Honey bee
- Source: Mr. R. Baker, 15 Abbots Crescent, St. Ives, Cambridgeshire, England
- Age at test initiation (mean and range, SD): no data
- Weight at test initiation (mean and range, SD): no data
- Date of collection:
- Cultural background (if honeybees):
- Disease free: no data
- Kept according to standard practices: no data


ACCLIMATION
- Acclimation period: Did not take place. Bees were dosed within 3-4 h of removal of the hide.
- Feeding: 20 % sucrose in water ad libitum
- Health during acclimation (any mortality observed): no data

Study type:

laboratory study

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

24 ± 1 ºC

Humidity:

The test room humidity was not controlled within the range 40 - 80 % and was not recorded during the test

Photoperiod and lighting:

The tests were conducted in darkness except for essential procedures, in order to minimise stress to the bees.

Details on test conditions:

TEST SYSTEM
- Test container / cage (material, size): cylindrical wire mesh cages 11.5 cm long × 4.0 cm diameter
- Details of emergence and fecundity chambers:
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 10
- No. of replicates per per control : 2


VEHICLE CONTROL PERFORMED: no


TEST CONCENTRATIONS
-Final study
- Test concentrations: 100 µg/bee
- Range finding study
- Test concentrations: 0.01, 0.1, 1.0, 10, 100 µg/bee
- Results used to determine the conditions for the definitive study: yes

Nominal and measured concentrations:

Nominal: 100 µg a.i./bee

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LD50

Effect conc.:

> 100 µg per animal

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Mortality of bees after oral and contact treatment with 100 µg/bee , 10 bees per group

Group	Oral		Contact
	24 h	48 h	24 h	48 h
1	0	2	0	1
2	0	0	0	0
3	0	1	0	0
4	0	0	0	0
5	0	0	0	2
6	0	1	0	1
7	0	0	0	0
8	1	3	0	0
9	0	0	0	1
10	0	0	0	1
	1 %	7 %	0 %	6 %
Untreated
1	0	1	0	0
2	0	0	0	0
	0 %	5 %	0 %	0 %

Executive summary:

Materials and methods: The acute oral and contact toxicity of ziram technical to honey bees was studied according to the United Kingdom Control of Pesticides Regulations 1986, Protocol.

10 groups of 10 bees were all dosed at the maximum concentration of 100 µg/bee. 2 untreated control groups were also observed.

For the contact test, one cage of bees at a time was lightly anasthetised with carbon dioxide and a 1.0µL droplet of the appropriate dilution of ziram was placed on the ventral surface of the thorax of each bee.

For the oral test, the appropriate concentration was administered as a single dose of 0.2 mL to each group of 10 bees in a cage.

Results and discussion: Mortalities of 7 % and 6 % after 48 h at the oral and contact tests, respectively, were observed. Because only one concentration of ziram was tested no dose-related response was obtained and no statistical analysis was required.

Ziram technical has a low toxicity to bees with an LD50 greater than 100 µg/bee by oral and contact application.

Reference 2

Endpoint:

toxicity to terrestrial arthropods: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

26 January 1989- 25 January 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EPA OPP 141-1 (Honey Bee Acute Contact Toxicity)

Deviations:

no

GLP compliance:

yes

Application method:

contact

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

Solution of ziram was prepared in dimethylsulphoxide (DMSO). The substance was used because ziram is insoluble in other solvents non-toxic to bees. The solubility of ziram in DMSO was found to be between 130 and 140 mg/L. DMSO does not interfere with absorption, distribution, metabolism or retention of ziram by the honeybees. DMSO does not alter the chemical properties of ziram or enhance, reduce or alter its toxic characteristics. DMSO does not affect the food and water consumption of the honeybees and DMSO does not produce physiological effects or have local or systemic activity to the honeybees.
Administration: bees of one cage at a time were lightly anaesthetised with carbon dioxide and a 1.0 µL droplet of the appropriate dilution of ziram was placed on the ventral surface of the thorax of each bee, using a micrometer syringe. The bees were then replaced in the cage.

Test organisms (species):

Apis mellifera

Animal group:

Hymenoptera (honeybees)

Details on test organisms:

TEST ORGANISM
- Common name: Honey bee
- Source: Mr. R. Baker, 15 Abbots Crescent, St. Ives, Cambridgeshire, England
- Age at test initiation (mean and range, SD):
- Weight at test initiation (mean and range, SD):
- Date of collection:
- Cultural background (if honeybees):
- Disease free: yes / no
- Kept according to standard practices: yes / no


ACCLIMATION
- Acclimation period: Did not take place. Bees were dosed within 3-4 h of removal of the hide.
- Feeding: 20 % sucrose in water ad libitum
- Health during acclimation (any mortality observed): no information

Study type:

laboratory study

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

24 ± 1 ºC

Humidity:

The test room humidity was not controlled with the range 40 - 80 % and was not recorded during the test period. Himidity is not important to bees provided that they have ad libitum fluid to drink.

Photoperiod and lighting:

In order to minimise stress, the tests were conducted in darkness except for essential procedures.

Details on test conditions:

TEST SYSTEM
- Test container / cage (material, size): cylindrical wire mesh cages 11.5 cm long × 4.0 cm diameter
- Details of emergence and fecundity chambers:
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 10
- No. of replicates per per control : 2


VEHICLE CONTROL PERFORMED: no


TEST CONCENTRATIONS
-Final study
- Test concentrations: 100 µg/bee
- Range finding study
- Test concentrations: 0.01, 0.1, 1.0, 10, 100 µg/bee
- Results used to determine the conditions for the definitive study: yes

Nominal and measured concentrations:

Nominal
Range finding test: 0.01, 0.1, 1.0, 10 and 100 µg a.i./bee
Final test: 100 µg/bee

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LD50

Effect conc.:

> 100 µg per animal

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Validity criteria fulfilled:

not specified

Executive summary:

Materials and methods: The acute contact toxicity of ziram technical to honey bees was studied according to the EPA Pesticide Assessment Guidelines for Non-target Insects, Subdivision L, Series 141-1.

10 groups of 10 bees were all dosed at the maximum concentration of 100 µg/bee. 2 untreated control groups were also observed.

Results and discussion: After dosing the bees recovered normally from anaesthesia in 5-10 minutes. No abnormal behaviour was observed after 4, 24 and 48 hours and normal quantities of 20 % sucrose in water were taken during this period. Because only one concentration of ziram was tested no dose-related response was obtained and no statistical analysis was required.

Ziram technical has a low toxicity to bees with an LD50 greater than 100 µg/bee by contact application.

Reference 3

Endpoint:

toxicity to terrestrial arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Oct - 08 Nov 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 226 (Predatory Mite (Hypoaspis (Geolaelaps) Aculeifer) Reproduction Test in Soil)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Application method:

mixed into soil

Analytical monitoring:

no

Vehicle:

no

Details on preparation and application of test substrate:

- Method of test material application: 37.3 g of the stock solution or of the corresponding dilutions were added to artificial soil equivalent to 260 g dry weight to prepare the target concentrations in the soil. The soil for each treatment group was moistened with deionised water and mixed with a laboratory mixer to ensure a homogeneous distribution. Each group was treated in one batch and then split into the replicates.
- Controls: The control was left untreated.

Test organisms (species):

Hypoaspis aculeifer

Animal group:

Acari (soil-dwelling predatory mite)

Details on test organisms:

TEST ORGANISM
- Source: cultured in laboratory
- Age at test initiation: approx. 12 days after reaching the adult stage (33 days after placing adult females in clean rearing vessels)
- Stage at test initiation: adult female
- Disease free: yes
- Introduction of individuals: Collected with a fine brush, put into a small glass tube, counted to ensure that 10 adult females are introduced and placed onto the surface of the treated artificial soil.
- Feeding: Two spatulas of cheese mites (Tyrophagus putrescentiae cultured by laboratory) at experimental start and 1-2 spatulas on day 2, 5, 7, 9 and 12.

Study type:

laboratory study

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18°C - 22°C

pH (if soil or dung study):

Experimental start: 5.8
Experimental end: 5.8 to 5.9

Humidity:

Experimental start: 22.5% to 22.9% (54.9% to 55.8% of the maximum water holding capacity)
Experimental end: 21.5% to 22.5% (52.5% to 54.8% of the maximum water holding capacity)

Photoperiod and lighting:

Photoperiod: 16 h light / 8 h dark
Light intensity: 400 - 800 lux

Details on test conditions:

TEST SYSTEM
- Test container (material, size): glass containers (100 mL, 5 cm), tight screw top closure to avoid water evaporation
- Amount of soil or dung or substrate: filled with approx. 20 g ± 1.0 g artificial soil dry weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8

SOURCE AND PROPERTIES OF SUBSTRATE
- Artificial soil based on OECD 226 was used.
- % sand: 5% Sphagnum-peat, air-dried and finely ground (with no visible plant remains) (Floragard, Vertriebs GmbH für Gartenbau, 26138 Oldenburg, Germany)
- % Sphagnum-peat: 5%, air-dried and finely ground (with no visible plant remains) (Floragard, Vertriebs GmbH für Gartenbau, 26138 Oldenburg, Germany)
- % clay: 20% Kaolin clay (Kaolinite content > 30%; Erbslöh, 65558 Lohrheim, Germany)
- Maximum water holding capacity: 41% of the dry weight
- Pretreatment of soil: The artificial soil was moistened to approximately half of the final water content 2 days before the application. The additional water required to achieve the final water content was added when applying the test item.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: within the range of 400 to 800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Assessment of adult mortality and reproduction performed after 14 d.

Nominal and measured concentrations:

Nominal concentrations: Control, 3.38, 5.07, 7.60, 11.4 and 17.1 mg a.s./kg soil dw

Reference substance (positive control):

yes

Remarks:

Perfekthion (a.s. dimethoate, 400 g/L, nominal)

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 17.1 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 17.1 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: No statistically significant mortalities compared to control.
- No. of offspring produced: The number of juvenile mites per replicate was 197 to 240.
- Morphological abnormalities: No differences in morphology of the mites between the test item treated groups and the control were observed.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels:
- Mortality: NOEC (14 d) = 2 mg/kg soil, LC50 (14 d) = 3.4 mg/kg soil
- Reproduction: NOEC (14 d) = 2 mg/kg soil, EC50 (14 d) = 4.2 mg/kg soil

Mortality of Hypoaspis aculeifer in the test item treated groups ranged from 3% to 13%, which was not statistically significantly different compared to the control, where a mortality of 6% was observed (Fisher's Exact Test, α = 0.05, one-sided greater).

There were no statistically significant effects on reproduction of Hypoaspis aculeifer up to and including the highest concentration of 22.5 mg test item/kg soil (Williams t-test,α= 0.05, one-sided smaller).

For more details on survival and reproduction results see attachment.

Table 1: Validity criteria for OECD 226 (2016)

Criterion from the guideline to be satisfied in the controls	Outcome	Validity criterion fulfilled
Mean adult female mortality is ≤ 20% at the end of the test.	Mean adult mortality was 6%	yes
The mean number of juveniles per replicate (with 10 adult females introduced) should be≥50 at the end of the test	The number of juvenile mites per replicate was 197 to 240	yes
The coefficient of variation calculated for the number of juveniles per replicate is ≤ 30%.	Was 6.6%	yes

Validity criteria fulfilled:

yes

Remarks:

For more details refer to field "any other information on results incl. tables"

Reference 4

Endpoint:

toxicity to terrestrial arthropods: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Oct - 21 Nov 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 232 (Collembolan Reproduction Test in Soil)

Version / remarks:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 11267 (Inhibition of Reproduction of Collembola by Soil Pollutants)

Version / remarks:

1999

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Application method:

mixed into soil

Analytical monitoring:

no

Vehicle:

no

Details on preparation and application of test substrate:

- Method of test material application: 37.3 g of the stock solution or of the corresponding dilutions were added to artificial soil equivalent to 260 g dry weight to prepare the target concentrations in the soil. Each group was treated in one batch and then split into the replicates.
- Introduction of Individuals: Collected with an aspirator, put into a small glass tube, counted to ensure that 10 individuals are introduced and placed onto the surface of the treated artificial soil.
- Controls: The control was left untreated and was moistened with deionised water.

Test organisms (species):

Folsomia candida

Animal group:

Collembola (soil-dwelling springtail)

Details on test organisms:

TEST ORGANISM
- Common name: springtails
- Source: laboratory culture
- Age at test initiation: 10 - 12 days old
- Stage at test initiation: female juveniles
- Disease free: yes
- Kept according to standard practices: yes

Study type:

laboratory study

Limit test:

no

Total exposure duration:

28 d

Test temperature:

18 - 22 °C

pH (if soil or dung study):

Experimental start: 5.8
Experimental end: 5.8 - 6

Humidity:

Experimental start: 22.5% - 22.9% (54.9% to 55.8% of the maximum water holding capacity)
Experimental end: 20.4% - 22.2% (49.6% to 54.3% of the maximum water holding capacity)

Photoperiod and lighting:

Photoperiod: 16 h light / 8 h dark
Light intensity: 400 to 800 lux

Details on test conditions:

TEST SYSTEM
- Test container: 100 mL glass containers (5 cm)
- Amount of soil: 30 g ± 1.0 g artificial soil
- No. of organisms per container (treatment): 10 female collembola
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- Feeding: 2 mg dry yeast for each test vessel at the beginning of the test and on day 14

SOURCE AND PROPERTIES OF SUBSTRATE (if soil or dung)
- Artificial soil according to OECD 232: 5% Sphagnum-peat, air-dried and finely ground (2 mm) (Floragard, Vertriebs GmbH für Gartenbau, 26138 Oldenburg, Germany)
- % sand: 74.8% fine quartz-sand (F34) containing more than 50% by mass of particle size 0.05 mm to 0.2 mm; (Quarzwerke Frechen, Postfach 1780, 50207 Frechen, Germany)
- % clay: 20% Kaolin clay (Erbslöh, 65558 Lohrheim, Germany)
- 0.2% calcium carbonate (CaCO3) was added to adjust pH to 6.0 ± 0.5
- Maximum water holding capacity: 41% of the dry weight
- Pretreatment of soil: The artificial soil was moistened to approximately half of the final water content 2 days before the application. The additional water required to achieve the final water content was added when applying the test substance.
- Stability and homogeneity of test material in the medium: Water content was checked on day 14 after the application by reweighing the additional test containers. It was not necessary to compensate for loss of water as deviation did not exceed 2% of the initial water content.


EFFECT PARAMETERS MEASURED :
Assessment of adult mortality, behavioural effects and reproduction (number of juveniles) was performed after 28 d.

TEST CONCENTRATIONS
- Range finding study : not specified

Nominal and measured concentrations:

Control, 3.38, 5.07, 7.60, 11.4 and 17.1 mg a.s./kg soil dry weight

Reference substance (positive control):

yes

Remarks:

Boric acid

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 17.1 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 17.1 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: No statistically significant mortalities compared to control.
- No. of offspring produced: Mean number of juvenile Collembola per replicate was 934 to 1302
- Other biological observations: For further details refer to attachments.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels:
- Mortality: NOEC (28 d) = 85.9 mg/kg dw, LC50 (28 d) = 207 mg/kg dw
- Reproduction: NOEC (28 d) < 33.6 mg/kg dw, EC10 (28 d) = 48.6 mg/kg dw, EC20 (28 d) = 62.2 mg/kg dw, EC50 (28 d) = 99.6 mg/kg dw

There were no statistically significant effects on reproduction of Folsomia candida up to and including the concentration of 22.5 mg Ziram 76 WG/kg soil (Williams t-test, α = 0.05, onesided smaller).

Mortality of Folsomia candida was not statistically significantly different compared to the control up to and including the test concentration of 22.5 mg Ziram 76 WG/kg soil (Fisher’s Exact Test, α = 0.05, one-sided greater).

For more details on survival and reproduction results see attachment.

Table 1: Validity criteria for OECD 232 (2016)

Criterion from the guideline to be satisfied in the controls	Outcome	Validity criterion fulfilled
Mean adult mortality over the 4 weeks of the test is ≤ 20%.	Mean adult mortality was 11%	yes
The mean number of juveniles per vessel (with 10 collembolans introduced) should be ≥ 100 juveniles by the end of the test.	Mean number of juvenile Collembola per replicate was 934 to 1302	yes
The coefficient of variation calculated for the number of juveniles per replicate is ≤ 30%.	Was 10.7%	yes

Validity criteria fulfilled:

yes

Remarks:

For more details refer to field "any other information on results incl. tables"

Reference 5

Endpoint:

toxicity to terrestrial arthropods: short-term

Remarks:

toxicity to bees: acute oral and acute contact

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 26 Jul 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 213 (Honeybees, Acute Oral Toxicity Test)

Version / remarks:

1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 214 (Honeybees, Acute Contact Toxicity Test)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Application method:

other: contact and oral

Analytical monitoring:

no

Vehicle:

yes

Remarks:

DMSO

Details on preparation and application of test substrate:

- Method of test material application:
- Contact test: One single 5 µL droplet of test substance in an appropr. carrier was placed on the dorsal bee thorax using a Burkard –Applicator. A 5 µL droplet was chosen in deviation to the guideline
recommendation of a 1 µL droplet, since a higher volume ensured a more reliable dispersion of the test item; The laboratory experience has proven that higher volumes are suitable and no adverse effects on the outcome of the study are to be expected.
- Oral test: The test item was dissolved in DMSO and mixed with tap water and sugar syrup solution. The final concentrations in the feeding solution were 2.5 % DMSO, 47.5 % tap water and 50 % sugar syrup solution.The treated food was offered in syringes, (duration of uptake was 45 minutes for the test item treatments). After a maximum of 45 minutes, the food consumption was completed and the syringes were removed, weighed and replaced by ones containing fresh, untreated food.
- Body part:
- Contact test: thorax
- Oral test: oral uptake
- Volume of test solution applied: 5 µL
- Controls:
- Contact test: For the water control and a solvent control (10 % DMSO + 90 % tap water with 0.5 % Adhäsit)one 5 µL droplet of tap water containing 0.5 % Adhäsit was used.
- Oral test: A water control (50 % tap water and 50 % sugar syrup solution) and a solvent control (2.5 % DMSO, 47.5 % tap water and 50 % sugar syrup solution) were used.
- Chemical name of vehicle: DMSO
- Starvation Time: 15 minutes for all treatment groups in the oral test, prior to application

Test organisms (species):

Apis mellifera

Animal group:

Hymenoptera (honeybees)

Details on test organisms:

TEST ORGANISM
- Common name: honeybees
- Source: bred in laboratory
- Age at test initiation: ca. 2 – 3 weeks old
- Cultural background: female worker bees
- Disease free: yes
- Health condition of the hive: disease-free and queen-right

Study type:

laboratory study

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

24 - 25 °C

Humidity:

62 % - 84 %

Photoperiod and lighting:

24 h darkness

Details on test conditions:

TEST SYSTEM
- Test container (material, size): stainless steel cages, 10 cm x 8.5 cm x 5.5 cm (length x height x width)
- No. of organisms per treatment: 10
- No. of replicates per treatment group: 5
- No. of replicates per control:
- Oral test: 5 (50% aqueous sugar syrup solution in tap water)
- Contact test: 5 (water + 0.5 % Adhäsit)
- No. of replicates per solvent control:
- Oral test: 5 (2.5 % DMSO, 47.5 % tap water, 50 % sugar syrup solution)
- Contact test: 5 (10 % DMSO + 90 % Tap water with 0.5 % Adhäsit)

OTHER TEST CONDITIONS
- Photoperiod: 24 h darkness
- Ventilation: Ventilation to avoid possible accumulation of pesticide vapour.

EFFECT PARAMETERS MEASURED:
- Oral and contact toxicity after 4, 24 and 48 h
- Behavioural abnormalities (e.g. vomiting, apathy, intensive cleaning) after 4 h (first day); 24 and 48 h

VEHICLE CONTROL PERFORMED: yes (DMSO)

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Range finding study : no

Nominal and measured concentrations:

Nominal: 100 µg Ziram technical/bee
Measured: 105.1 µg Ziram technical/bee

Reference substance (positive control):

yes

Remarks:

dimethoate

Key result

Duration:

48 h

Dose descriptor:

LD50

Effect conc.:

> 105.1 µg per animal

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

LD50

Effect conc.:

> 100 µg per animal

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: contact

Details on results:

- Mortality at end of exposure period: neither in treatments with test material nor in the controls
- Behavioural abnormalities: no
- Other biological observations: No test item induced behavioural effects were observed at any time.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Relevant effect levels: LD50 (24 h, contact) = 0.22 µg/bee, LD50 (24 h, oral) = 0.13 µg/bee

Table 1: Validity criteria for OECD 213 and 214 (1998)

Criterion from the guideline	Outcome	Validity criterion fulfilled
The average mortality for the total number of controls must not exceed 10% at the end of the test.	0% in both negative and solvent controls in contact and oral tests.	yes
The LD50 of the toxic standard meets the specified range (0.10 – 0.35 µg a.i./bee, 24 h).	Contact test: 0.22 µg a.i./bee Oral test: 0.13 µg a.i./bee	yes

Validity criteria fulfilled:

yes

Remarks:

For details refer to field "Any other information on results incl. tables"

Description of key information

NOEC ≥ 17.1 mg a.i./kg soil dw (mortality and reproduction, Folsomia candida and Hypoaspis aculeifer, OECD 232 and 226)

LD50 (48 h) > 100 µg/bee (Apis mellifera, OECD 213, 214)

Additional information

Three studies are available assessing the short-term toxicity of zinc bis dimethyldithiocarbamate (CAS No. 137-30-4) to terrestrial arthropods and two studies assessing its long-term effects.

The first key study (2014) investigated the long-term effects of Ziram 76 WG to terrestrial arthropods and was conducted according to the OECD Guideline No. 232 and GLP. The Collembola Folsomia candida were exposed in artificial soil for 28 d to test item concentrations of 3.38, 5.07, 7.60, 11.4 and 17.1 mg a.i./kg soil. Mortality of adult Collembola, behavioural effects and number of juveniles were observed. Boric acid was used as a reference substance. Ziram 76 WG caused no statistically significant effects on mortality or reproduction of Folsomia candida up to and including the highest tested concentration resulting into a NOEC (mortality and reproduction, 28 d) of≥17.1 mg a.i./kg soil dw.

The second key study (2014) investigated the long-term effects of Ziram 76 WG to terrestrial arthropods and was performed according to the OECD Guideline No. 226 and GLP. Predatory mite Hypoaspis aculeifer were exposed in artificial soil for 14 d to test item concentrations of 3.38, 5.07, 7.60, 11.4 and 17.1 mg a.i./kg soil dw. Adult mortality and number of juveniles were observed. Perfekthion (a.i. dimethoate) was used a reference substance. Ziram 76 WG caused no statistically significant effects on mortality or reproduction ofHypoaspis aculeiferup to and including the highest tested concentration resulting into a NOEC (mortality, reproduction, 14 d) of≥17.1 mg a.i./kg soil dw. The results of both long-term studies are therefore consistent to each other.In the key study the acute toxicity of zinc bis dimethyldithiocarbamate (CAS No. 137-30-4) to honey bees was tested according to the OECD Guidelines No. 213 and 214. The study was performed under GLP. Honeybees were exposed for 48 h to 100 µg test item/bee (nominal) in an acute contact test and 105.1 µg/bee (meas.) in an acute oral toxicity test. DMSO was used as a vehicle. No mortalities were observed in any case, leading to LD50 (48 h) values of > 100 and 105.1 µg/bee for the contact and oral toxicity, respectively.

Three further studies investigated the short-term effects of zinc bis dimethyldithiocarbamate (CAS No. 137-30-4) to honey bees.

In the key study the acute toxicity of the substance to honey bees was tested according to the OECD Guidelines No. 213 and 214. The study was performed under GLP. Honeybees were exposed for 48 h to 100 µg test item/bee (nominal) in an acute contact test and 105.1 µg/bee (meas.) in an acute oral toxicity test. DMSO was used as a vehicle. No mortalities were observed in any case, leading to LD50 (48 h) values of > 100 and 105.1 µg/bee for the contact and oral toxicity, respectively.

Two further supporting studies (1990) are available testing the acute toxicity of the substance to honey bees. These studies were conducted according to EPA OPP Guideline 141-1 (Honey Bee Acute Contact Toxicity) and Working Document 7/3 of the United Kingdom Control of Pesticides Regulations (1986), under GLP conditions. After 48 hours, no significant effects on survival were reported in honeybees exposed via oral or contact route to the test material. Therefore, the resulting LD50 for both tests was greater than 100 µg/animal and results are consistent compared to the key study.