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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-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 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Version / remarks:
2004
Qualifier:
according to guideline
Guideline:
ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
Version / remarks:
1998
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Details on preparation and application of test substrate:
- Method of mixing into soil: test item was weighed in directly on quartz sand, mixed and moistened. Then the test item was mixed into artifical soil.
- Controls: 4 replicates
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: earthworm
- Source: laboratory rearing stock maintained in the testing facility
- Age at test initiation: at least two months old, but not older than 1 year with a clitellum (age of the worms did not idffer by more than four weeks)
- Weight at test initiation (range): between 350 and 450 mg

ACCLIMATION
- Acclimation period: 1day
- Acclimation conditions: same as test
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
56 d
Test temperature:
20.1 - 23.9 °C
pH:
study inititation: 6.4 - 6.5
study end: 6.7 - 6.9
Moisture:
water content at study initiation: 24.2 - 25.4 %
water content at study end: 24.1 - 26.6 %
Details on test conditions:
TEST SYSTEM
- Test container (material, size): BELLAPLAST, 17 cm x 12.5 cm x 6 cm
- Amount of soil or substrate: 749 g moistened substrate ( corresponding to 600 g dry substrate)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate):
- 10 % sphagnum peat (close to pH 5.5-6.0; no visible plant remains, finely ground, air dry)
- 20 % kaolin clay (kaolinite content above 30%)
- 70 % industrial sand (fine sand dominant with more than 50% of the particles between 50 and 200 microns)
- Maximum water holding capacity (in % dry weight): 40.36%
- Pretreatment of soil: after mixing the components, i.e. before pre-moistening, 10 g air-dried finely ground cow manure per 1 kg substrate were added
- Storage (condition, duration): in a closed container

OTHER TEST CONDITIONS
- Photoperiod: 16 h light, 8 h darkness
- Light intensity: 500 - 650 lux

EFFECT PARAMETERS MEASURED: Mortality, and body weight change were recorded after 28 days; number of offspring were determined after 56 days

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: yes
- Test concentrations: control, 150, 225, 338, 506 mg a.i./kg soil dry weight
- Results used to determine the conditions for the definitive study: no mortality after 28 days, mean weight change between 14.3 and 31.2%
Nominal and measured concentrations:
nominal test concentrations: 72, 129, 232, 417, 750 mg i.a/kg soil dry weight
Reference substance (positive control):
yes
Remarks:
Carbendazim
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 750 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
other: reproduction and body weight
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
> 750 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: none
- Changes in body weight of live adults (% of initial weight) at end of exposure period: 49.1, 44.4, 43.2, 52.3 and 58.5 % in the test item treatment groups at 72, 129, 232, 417 and 750 mg a.i./kg soil dry weight; in the control the average body weight change was 49.7 %. The body weight change was not statistically significantly different from the control in any of the test item treatment groups.
- Morphological abnormalities: none
- Behavioural abnormalities: none
Results with reference substance (positive control):
In a test conducted from 24 May to 20 Aug 2011 a statistically significant reduction in reproduction of 68% was observed.

Table 1 Effect on mortality, body weight change and reproduction

Test concentration[mg a.i./kgdw]

Contro1

72

129

232

417

750

Mortality [%]

0

0

0

0

0

0

Mean weight change [%]

49.7

49.1

44.4

43.2

52.3

58.5

Juveniles/replicate [mean]

124.4

103.8

97.0

138.5

117.3

111.3

Reproduction[%]

( deviationfrom control)

-

-16.6

-22.0

+11.3

-5.71

-10.5

Table 2: Number of juvenile worms per vessel after 56 days of exposure to the test item

Texapon N 70
[mg a.i./kg sdw]

Number of juvenile worms
per replicate (n=10)

Mean value

±SD

CV
[%]

Difference to control
[%]

1

2

3

4

5

6

7

8

Control

107

108

110

118

168

124

113

147

124.4

21.9

17.6

 -

72

103

118

92

102

 -

 -

103.8

10.7

10.3

-16.6

129

85

128

104

71

 -

 -

97.0

24.7

25.5

-22.0

232

152

156

144

102

 -

 -

138.5

24.8

17.9

+11.3

417

102

105

124

138

 -

 -

117.3

16.9

14.4

-5.71

750

105

128

123

89

 -

 -

111.3

17.8

16.0

-10.5

SD = Standard Deviation                            sdw = soil dry weight         
CV = Coefficient of Variation

Table 3: Validity criteria for OECD 222 (2016)

Criterion from the guideline to be satisfied in the controls

Outcome

Validity criterion fulfilled

Adult mortality over the initial 4 weeks of the test is ≤ 10%.

0%

yes

Each replicate (containing 10 adults) to have produced ≥ 30 juveniles by the end of the test.

107-168

yes

The coefficient of variation of reproduction is ≤ 30%.

17.6%

yes

Description of key information

NOEC (56 d)≥750 mg a.i./kg soil dw (OECD 222)

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
750 mg/kg soil dw

Additional information

The toxicity of Alcohols, C12-14, ethoxylated, sulfates, sodium salts to earthworms was investigated in a GLP guideline study conducted according to OECD 222. Eisenia fetida were exposed to nominal test concentrations of 72, 129, 232, 417, and 750 mg i.a/kg soil dry weight in artificial soil. The total study duration was 56 days. After 28 days mortality and body weight change of adult worms was recorded. After 56 days the number of offspring was determined. No mortality and no significant changes in body weight change and reproduction rate were overserved. The determined NOEC (56 d) was≥750 mg a.i./kg soil dw.