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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

This endpoint study is waived.

The registered substance is used in cosmetic products and for fuel. The latter is not expected lead to direct exposure of the registered substance to soil (or water). The use of the registered substance in cosmetic products will lead to a discharge to waste water. Also, the manufacture and formulation life cycle stages will lead to discharges to waste water. The registered substance may reach agricultural soil due to sludge application.

As no effects are observed in the short-term tests and the long-term test at concentrations below the water solubility (algae, crustacean), then a conservatively calculated PNEC for surface water (fresh) would be: SW/AF, where AF is the assessment factor: 50.

Conservative EUSES calculations have then been carried out, where the concentration in the waste water (before any treatment)of each identified component in the registered substance has been set equal to its water solubility multiplied with the mole fraction of the component in the registered substance. This is done both at the regional and at the local scale. Then the concentration in both agricultural soil and agricultural soil pore water has been calculated. The latter was then compared with the PNEC for fresh water (equilibrium partition method).

The below table shows the results. It is seen that the calculated concentration in soil is very low with a total concentration of approximately 0.02 mg/kg dm. The overall RCR for soil pore water is very conservatively calculated at 0.45, i.e. well below 1.

Substance

CAS-RN

logKOW

SW(mg/L)

MW(g/mole)

Weight percent-tage

Mole fraction

PEC(soil) (mg/kg dm)

PEC(Soil pore water)

RCR(soil pore water)

9-Octadecenoic acid (Z)-, ethyl ester

111-62-6

8.5

0.0008

310.52

45.1

0.50

9.0E-03

3.6E-06

2.3E-01

Octadecanoic acid, ethyl ester

111-61-5

8.72

0.0004

312.54

23.1

0.26

2.4E-03

7.5E-07

9.4E-02

9,12-Octadecadienoic acid (Z,Z)-, ethyl ester

544-35-4

8.29

0.0009

308.51

1.8

0.02

3.9E-04

2.0E-07

1.1E-02

Ethyl (Z)-docos-13-enoate

37910-77-3

10.47

0.000006

366.63

3.2

0.03

6.5E-06

3.2E-10

2.7E-03

Hexadecanoic acid, ethyl ester

628-97-7

7.74

0.004

284.49

7.2

0.09

6.9E-03

6.4E-06

8.0E-02

Tetradecanoic acid, ethyl ester

124-06-1

6.76

0.04

256.42

0.1

0.001

2.0E-04

4.6E-07

5.7E-04

9-Octadecenoic acid (Z)-, methyl ester

112-62-9

7.45

0.006

296.5

4.1

0.05

1.3E-03

1.4E-06

1.2E-02

Octadecanoic acid, methyl ester

112-61-8

8.35

0.001

298.51

1.9

0.02

4.8E-04

2.3E-07

1.1E-02

9,12-Octadecadienoic acid (Z,Z)-, methyl ester

112-63-0

6.82

0.02

294.48

0.4

0.005

3.6E-04

7.6E-07

1.9E-03

Hexadecanoic acid, methyl ester

112-39-0

7.38

0.01

270.46

0.3

0.004

1.7E-04

2.0E-07

9.9E-04

C16-C18 free acids

 

7.17

0.04

256.43

0.8

0.01

1.8E-03

2.7E-06

3.3E-03

C18 propyl esters

 

9.2

0.0001

326

0.9

0.01

2.3E-05

4.4E-09

2.2E-03

Sum

1.00

2.3E-02

0.45

 

As the RCR based on very conservative calculations for soil pore water is well below 1, then the registered substance is not expected to exhibit a risk the soil organism. Therefore, studies on toxicity to soil organisms are waived.