Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue approach justification provided in section 13.

Reason / purpose for cross-reference:

read-across source

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

Remarks on result:

other:

Remarks:

Source, key, 68891-38-3, BASF, 2012

Duration:

56 d

Dose descriptor:

EC50

Effect conc.:

> 750 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other:

Remarks:

Source, key, 68891-38-3, BASF, 2012

Reference 2

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

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))

Qualifier:

according to guideline

Guideline:

ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)

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, behavioural abnormalities and pathological symptoms 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: control, 150, 225, 338, 506 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:

56 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
- Total mass of adults at beginning of test:
- 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 %
- Morphological abnormalities: none
- Behavioural abnormalities: none

Results with reference substance (positive control):

in a test conducted from 24 May to 20 Aug 2011 (report no. S11-01755) a statistically significant reduction in reproduction of 68% was observed.

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

Description of key information

NOEC (56 d) = 750 mg a.i./kg soil dw  for Eisenia fetida 

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:

750 mg/kg soil dw

Additional information

According to the REACH Regulation ANNEX VIII tests on the toxicity to soil organisms are not a data requirement for this tonnage band. Furthermore the substance is expected to biodegrade rapidly. Therefore, soil is not expected to be a compartment of concern.

However a read-across study from a comparable AES(C12-14, 2EO)Na (CAS 68891-38-3) is available.

In this test individuals of Eisenia fetida were exposed to different test concentrations of AES(C12-14, 2EO)Na (CAS 68891-38-3). The study was performed according to OECD guideline 222 and GLP. The NOEC (56 d) for body weight change and reproduction was determined as 750 mg a.i./kg soil dry weight. Up to the highest test concentration (750 mg a.i./kg soil dry weight) no mortality was observed (BASF, 2012).