Octadecanoic acid, 12-hydroxy-, reaction products with decanoic acid and ethylenediamine

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 December 2013

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

1984

GLP compliance:

yes

Remarks:

According to “The guidelines for the testing of chemical (HJfT 153-2004)" and "The guidelines of chemical testing good laboratory practices (HJT 155)" issued by State Environmental Protection Administration (SEPA) of the People's Republic of China.

Analytical monitoring:

not required

Vehicle:

no

Remarks:

The test item was directly added into the soil.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Source: the worms were obtained from an earthworm nursery of Nanjing in China.
- Age at test initiation (mean and range, SD): adult (two months old with clitellium).
- Weight at test initiation (mean and range, SD): adult with average weight of 388 mg.

ACCLIMATION
- Acclimation period: before the test, the worms were aclimated in no polluted soil for 24 days.
- Acclimation conditions (same as test or not): the worms were then pre-cultured in test soils another 24 hours. The worms were washed quickly with distilled water and surplus water absorded on filter paper before use.
- Health during acclimation (any mortality observed): not reported.

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

20°C - 22°C

pH:

pH 6 - 6,3

Moisture:

31% - 36%

Details on test conditions:

TEST SYSTEM
- Amount of soil or substrate: 740 g dry weight of soil for each container.
- No. of organisms per container (treatment): 10 individuals.
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

OTHER TEST CONDITIONS
- Photoperiod: continuous light
- Light intensity: 400 - 800 Lux /

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Range finding study : a pre-test was performed with test substance concentrations of 10, 100 and 1000 mg/kg artificial soil (dry weight).
- Results used to determine the conditions for the definitive study: no effects were observed in the range finder.

Nominal and measured concentrations:

BAsed on the result of the range-finding test, a limit test was undertaken with test substance concentration of 1000 mg/kg dw of soil and a blank control.

Reference substance (positive control):

yes

Remarks:

2-Chloracetamide (CAS 79-07-2), Purity > 98.5% Lot 20070329.

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Basis for effect:

mortality

Details on results:

- Behavioural abnormalities: None. During the test, all earthworms remained in the soil.

Results with reference substance (positive control):

The LC50 of a reference substance (2-chloracetamide) were determined to assure that the laboratory test conditions were adequate and had not changed significantly. For more details, please see the attached document containing all the biological results of this study.

Reported statistics and error estimates:

The LC50 and 95% confidence limits can be used to calculate by Trimmed Spearman-Karber Method (version 1.5 USEPA).

pH and Moisture content of the artificial soil :

Concentration applied to soil (mg/kg (dry soi!))	pH		Moisture content CD(%)
	0 d	14 d	0 d	14 d
0	6.0	6.2	36	32
0	6.1	6.3	32	36
0	6.2	6.0	32	34
0	6.3	6.0	36	32
1000	6.0	6.3	33	34
1000	6.1	6.2	35	33
1000	6.3	6.3	36	36
1000	6.1	6.2	35	31
Min	6	6	32	31
Max	6.3	6.3	36	36

Validity criteria fulfilled:

yes

Conclusions:

During this test, artificial soils was used with the moisture content of the test medium controlled in range of 31 % to 36% with pH from 6.0 to 6.3. The test conditions were maintained as follows: temperature of 20°C to 22°C humidity of 80% to 85% and continuous light with intensity of 400 lux to 800 lux.
The result indicated that the 14 d-LC50 of the test substance in the artificial soil was greater than 1000 mg/kg dry weight soil. According to the test result, no effect was observed at the highest dose tested (1000 mg/kg dry weight).

Executive summary:

The test was conducted to determine the acute toxicity of test substances (99422018) to earthworm according to "The guidelines for the testing of chemicals" (HJ/f 153-2004) and "The guidelines for the testing of chemicals" (SEPA. Beijing: China Environmental Sciences Press. 2004); while with reference to Procedure 207 of the 'Guidelines for Testing of Chemicals' of the OECD: "Earthwonn, Acute Toxicity Tests" (1984) etc.

During this test, the artificial soils was used with the moisture content of the test medium controlled in range of 31 % to 36% and pH from 6.0 to 6.3 The test conditions were maintained as follows: temperature of 20°C to 22°C, humidity of 80% to 85% and continuous light with intensity of 400 lux to 800 lux.

Based on the result of range-finding test and the Limit Test, the 14 d-LC50 of the test substance in the artificial soil was determined to be greater than 1000 mg/kg dry weight soil. According to the test result, no effect was observed at the highest dose tested (1000 mg/kg dry weight).

Description of key information

A key study according to the TG OECD 207 is available on terrestrial earthworms, no acute effect was observed at the highest dose tested (14 d - LC50 > 1000 mg/kg dw).

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Additional information

According to the REACH guidance document R7c page 158, the registered substance has a log Kow > 5 and is not toxic according to the terrestrial ITS. Therefore it falls into the Soil Hasard Category 3 and a TG OECD 216 should be performed. Actually no toxicity on terrestrial macroorganisms is needed. However a study is available according to a TG OECD 207 and China GLP. No acute effects on terrestrial earthworms were observed, the endpoint is LC50 > 1000 mg/kg dw.