Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

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 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

yes

Specific details on test material used for the study:

- Storage condition of test material: at room temperature at abput 20 °C, away from direct sunlight

Analytical monitoring:

no

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil: the test substance was mixed directly with a portion of sand prior to addition to the artificial soil. For the preparation of the sand/test item mixtures, the amounts of 34.8, 69.5, 139, 278 and 556 mg of the test were weighed by an analytical balance and mixed into 10 g of sand each by means of a roller mixer. The sand/test item mixtures were prepared immediately before the start of the test. Each replicate was quantitatively incorporated into 556 g of artificial soil (dry weight) by intensely mixing.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Source: obtained from a breeding stock maintained at RCC
- Age at test initiation: adults with clitellum approx. 4 months old
- Weight at test initiation (mean range): 350 - 432 mg

HOUSING
- Feeding: horse manure, potatoes

ACCLIMATION
- Acclimation period: one day
- Acclimation conditions: artificial soil and test temperature

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18 - 21 °C

pH:

- Initial pH = 5.8
- pH at test end: 5.9 - 6.2

Moisture:

- Initail moisture content: 35%
- Moisture at test end: 33-34%

Details on test conditions:

TEST SYSTEM
- Test container: cylindrical glass vessels (diameter 10 cm, height 14 cm) covered with glass lids
- Amount of soil or substrate: 556 g artificial soil dry weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 5
- No. of replicates per control: 5

OTHER TEST CONDITIONS
- Photoperiod: coninuous illumination
- Light intensity: 526 - 631 lux

EFFECT PARAMETERS MEASURED:
- Mortality and symptoms of toxicity: after 7 and 14 days
- Body weight after: 0 and 14 days
- Soil moisture after: 0 and 14 days
- pH: after 0 and 14 days
- Temperature: continuously

TEST CONCENTRATIONS
- Range finding study: yes

Nominal and measured concentrations:

Nominal test concentrations: control, 62.5, 125, 250, 500, 1000 mg/kg dry soil (based on range-finding study)

Reference substance (positive control):

yes

Remarks:

2-chloroacetamide (test is performed once a year)

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC100

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: none
- Abnormal behaviour: none
- Symptoms of toxicity: none
- Body weight: not affected

Validity criteria fulfilled:

yes

Conclusions:

No toxic effects have been observed in studies with soil living organisms.

Reference 2

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

yes

Specific details on test material used for the study:

- Storage condition of test material: ambient 22 °C, protected from sunlight, humidity 50%

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil: the test item was mixed with fine quartz sand and then this mixture was applied to artificial soil. In order to obtain a better distribution of the test item the amount of treated artificial soil for two replicates was prepared in one step.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Source: BASF Agricultural Centre, Limburgerhof, Germany. Bred under standardised conditions in the Laboratory of LAB research Ltd. Veszprém-Szabadságpuszta
- Age at test initiation: adults, 6 months (not differing in age by more than 4 weeks) with clitellum

HOUSING
- Culture vessel: glass conatiners of approx. 1 L covered with transparent punctured lids
- Illumination: continueously at about 720 lux

ACCLIMATION
- Acclimation period: 1 day
- Acclimation conditions: same as test

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18.4 - 20.8 °C

Moisture:

30.9% dw

Details on test conditions:

TEST SYSTEM
- Test container: glass containers covered with transparent punctured lid
- Amount of soil or substrate: 750 g wet weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity: 720 lux

EFFECT PARAMETERS MEASURED:
- Mortality after 7 and 14 days
- Worm biomass after 0 and 14 days

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: control, 3.33, 10, 33.3, 100, 333, 1000 mg/kg dw

Nominal and measured concentrations:

Nominal test concentrations: control, 62.5, 125, 250, 500, 1000 mg/kg (based on range-finding study)

Reference substance (positive control):

yes

Remarks:

2-chloroacetamide

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

250 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and biomass

Results with reference substance (positive control):

14-d LC50 = 30.29 mg/kg dw

Validity criteria fulfilled:

yes

Description of key information

No toxic effects have been observed in studies with soil living organisms.

Additional information

Due to the structural characteristics and the low solubility in water and octanol toxic effects on terrestrial organisms are not expected.

This assumption is supported by two guideline studies on Eisenia fetida following OECD guideline 207. The animals were exposed to the test substance for 14 days. The test substance was mixed with artificial soil. In the key study a NOEC of >= 1000 mg/kg dry soil and a LC50 of > 1000 mg/kg dry soil was determined. These results are supported by the supporting study reporting a LC50 >1000 mg/kg dw.

Furthermore, to address the chronic toxicity to soil macroorganisms, an Earthworm, reproduction test has been ordered.