Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to terrestrial arthropods

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
toxicity to terrestrial arthropods: short-term
Type of information:
experimental study
Adequacy of study:
other information
Study period:
11 - 16 Apr 1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 214 (Honeybees, Acute Contact Toxicity Test)
GLP compliance:
no
Application method:
contact
Analytical monitoring:
not required
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of test material application: single topical dose
- Body part: dorsal-thorax
- Volume of test solution applied: 1 µL
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
Test organisms (species):
Apis mellifera
Animal group:
Hymenoptera (honeybees)
Details on test organisms:
TEST ORGANISM
- Common name: Honeybee
- Source: Purchased from Nonogaki Bee Farm in Aichi prefecture, in February 1996
- Age at test initiation (mean and range, SD): Workers after emergence 4 to 7 days were used
- Stage at test initiation: workers
- Cultural background (if honeybees): Hybrid colony for pollination
Study type:
laboratory study
Limit test:
no
Total exposure duration:
48 h
Test temperature:
32 °C
Details on test conditions:
TEST SYSTEM
- Test container / cage (material, size): plastic cups (RISU PACK®, diameter: 101 mm, hight: 45 mm, volume: 238 mL)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 3
- No. of replicates per control / vehicle control: 3
- No. of trials: 2
- Food: fed with honey during exposure

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): After 24 and 48 hours, number of dead bees was counted.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5 to 2
- Test item was dissolved in acetone and diluted to the designed concentrations.
Nominal and measured concentrations:
control, 12.5, 25, 50, 100, and 150 µg/animal (nominal)
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LD50
Effect conc.:
> 150 µg per animal
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 150 µg per animal
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Table 1: Effect of the test substance against honeybee with topical application method; Trial 1

 

Dose [µg/animal]

No. of bees

Number of dead bees

Mortality [%]

24 hrs

48 hrs

Test substance

150

30

0

0

0

100

30

0

0

0

50

30

0

0

0

25

30

0

0

0

12.5

30

0

0

0

Control

-

30

0

0

0

 

Table 2: Effect of the test substance against honeybee with topical application method; Trial 2

 

Dose [µg/animal]

No. of bees

Number of dead bees

Mortality [%]

24 hrs

48 hrs

Test substance

150

30

0

0

0

100

30

0

0

0

50

30

0

0

0

25

30

0

0

0

12.5

30

0

0

0

Control

-

30

0

0

0

 

Endpoint:
toxicity to terrestrial arthropods: short-term
Type of information:
experimental study
Adequacy of study:
other information
Study period:
11 - 16 Apr 1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 214 (Honeybees, Acute Contact Toxicity Test)
GLP compliance:
no
Application method:
contact
Analytical monitoring:
not required
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of test material application: single topical dose
- Body part: dorsal-thorax
- Volume of test solution applied: 1 µL
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
Test organisms (species):
Apis mellifera
Animal group:
Hymenoptera (honeybees)
Details on test organisms:
TEST ORGANISM
- Common name: Honeybee
- Source: Purchased from Nonogaki Bee Farm in Aichi prefecture, in February 1996
- Age at test initiation (mean and range, SD): Workers after emergence 4 to 7 days were used
- Stage at test initiation: workers
- Cultural background (if honeybees): practical hybrid for mating
Study type:
laboratory study
Limit test:
no
Total exposure duration:
48 h
Test temperature:
32 °C
Details on test conditions:
TEST SYSTEM
- Test container / cage (material, size): plastic cups (RISU PACK®, diameter: 101 mm, hight: 45 mm, volume: 238 mL
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 3
- No. of replicates per control / vehicle control: 3
- No. of trials: 2
- Food: fed with honey during exposure (placed in a centrifugal pipe, which was inserted into the cover of the container cup)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): After 24 and 48 hours, number of dead bees was counted

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5 to 2
- Test item was dissolved in acetone and diluted to the designed concentrations.
Nominal and measured concentrations:
control, 12.5, 25, 50, 100, and 150 µg/animal (nominal)
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LD50
Effect conc.:
> 150 µg per animal
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 150 µg per animal
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Table 1: Effect of the test substance against honeybee with topical application method; Trial 1

 

Dose [µg/animal]

No. of bees

Number of dead bees

Mortality [%]

24 hrs

48 hrs

Test substance

150

30

0

0

0

100

30

0

0

0

50

30

0

0

0

25

30

0

0

0

12.5

30

0

0

0

Control

-

30

0

0

0

 

Table 2: Effect of the test substance against honeybee with topical application method; Trial 2

 

Dose [µg/animal]

No. of bees

Number of dead bees

Mortality [%]

24 hrs

48 hrs

Test substance

150

30

0

0

0

100

30

0

0

0

50

30

0

0

0

25

30

0

0

0

12.5

30

0

0

0

Control

-

30

0

0

0

 

Description of key information

Key value for chemical safety assessment

Additional information

In accordance with Regulation (EC) No 1907/2006, Annex IX, column 2, testing of effects on terrestrial organisms is not required since direct and indirect exposure of the soil compartment for the substance 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-tetrazole-1-carboxamide is unlikely. Furthermore, the evaluation of the PEC/PNEC ratio indicates no risk for the terrestrial compartment (RCR << 1). For detailed information, see Chemical Safety Report (CSR) chapter 9 and 10.

Two studies are available (1997a, 1997b) investigating the toxicity of the test substance to terrestrial arthropods. No guideline was given in the study reports, nor were the studies conducted according to GLP, but the study procedure is comparable to OECD 214. Apis mellifera was used as test organism. Thirty bees, 10 per replicate, were exposed for 48 h to a range of test substance doses between 12.5 and 150 µg per animal. The test item was dissolved in acetone. 1 µL test substance dilution was applied by single topical application on the dorsal thorax. Two trials were conducted. No mortalities and no effects were observed in both studies. Thus, a LD50 greater than 150 µg per animal was determined.

Further data from a non-guideline, non-GLP study with silkworm larvae (Bombyx mori) is available. Serial water dilutions of the test substance at 1000 ppm and at 100 ppm with a surfactant 0.1% Neoesterin were prepared. Tested mulberry leaves were dipped in each of them. The leaves for the control group were dipped in water with surfactant. Silkworms were fed on mulberry leaves for 25 days. The living and dead larvae were counted, and the feces were weighed every day until cocoons were formed. The weight of silkworm feces indicated the amount of mulberry leaves ingested. After that, quality of cocoons was investigated. For each dosage, twenty silkworms were used without replication. No mortality and no toxic symptoms were observed in both treatments. However, growth of the silkworm in the group dosed at 1000 ppm was delayed three days compared to the control group. There was no difference in weight of silkworm feces between the 100 ppm and the control group. The weight of the feces at 1000 ppm was less compared to the control group. The quality of cocoons in the 1000 ppm and 100 ppm groups was comparable to the control group.