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Endpoint:
activated sludge respiration inhibition testing
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 justification for grouping of substances provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Conclusions:
An activated sludge respiration inhibition 3hr EC50 value of >100 mg/l (loading rate) was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP. This indicates that the test substance was not toxic to waste water (activated sludge) bacteria at a loading rate of 100 mg/l.
Endpoint:
activated sludge respiration inhibition testing
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-09-03 to 2009-09-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
53 µl of the test substance, Milli-RO water, synthetic sewage feed (16 ml) and activated sludge (200 ml) were mixed and made up to 500 ml with Milli-RO water in a 1 litre bottle.
Test organisms (species):
activated sludge of a predominantly domestic sewage
Details on inoculum:
Preparation of inoculum for exposure: The sludge was coarsely sieved to remove large particles. The sludge was then washed by centrifuging at 1000 g for 10 minutes. The supernatant was decanted and replaced with ISO-medium. The washing step was performed three times. The pH was 7.7 on the day of testing. The batch of sludge was used one day after collection; therefore 50 ml of synthetic sewage feed was added per litre of activated sludge at the end of the collection day. The sludge was kept aerated at test temperature until use.

- Initial biomass concentration: 3.8 g/L
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
3 h
Post exposure observation period:
Oxygen consumption was measured and recorded for approximately 10 minutes.
Test temperature:
19.9-20.3°C
pH:
8.2 to 8.3
Nominal and measured concentrations:
100 mg/l (loading rate). Performance of a limit concentration at 100 mg/l is acceptable, because 100 mg/l exceeds the expected concentration in a Sewage Treatment Plant.
Details on test conditions:
Test vessel:
- Material, size, headspace, fill volume: glass, 300ml oxygen bottles, 1L test bottles
Reference substance (positive control):
yes
Remarks:
(3,5-Dichlorophenol)
Duration:
3 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Remarks:
respiration rate
Details on results:
The two controls had a difference in respiration rate of 6%, which is less than the 15% limit required by the guideline for a valid study.
Results with reference substance (positive control):
A positive control test with 3, 5-dichlorophenol yielded an EC50 of 8.7 mg/L, which is within the accepted range of 5 to 30 mg/l required by the guideline for a valid study.

Table 1: Results of the activated sludge respiration inhibition test

Test sample

Loading rate (mg/l)

Oxygen conc. at start (mg O2/l)

Oxygen consumption (mg O2/l/h)

% Inhibition

respiration rate

pH

 

 

Initial control

0

7.3

34

-

8.3

Final control

0

6.5

32

-

8.2

Trimethoxy(methyl)silanereplicate (1)

100

7.1

33

0

8.3

Trimethoxy(methyl)silane replicate (2)

100

7.1

31

6

8.3

 

 

3,5-dichlorophenol

5

-

-

38

-

12

-

-

59

-

30

-

-

72

-

 

 

Validity criteria fulfilled:
yes
Conclusions:
An activated sludge respiration inhibition 3hr EC50 value of >100 mg/l (loading rate) was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP. This indicates that the test substance was not toxic to waste water (activated sludge) bacteria at a loading rate of 100 mg/l.

Description of key information

3hr EC10 value of >100 mg/l (loading rate) (OECD 209, read across from CAS 1185 -55 -3).

Key value for chemical safety assessment

Additional information

There are no microorganism toxicity data available for triethoxypropylsilane, therefore good quality data for the structurally-related substance trimethoxy(methyl) silane (1185-55-3), have been read across.Both substances hydrolyse to structurally-related silanol hydrolysis products, propylsilanetriol and methylsilanetriol.

Both triethoxypropylsilane and trimethoxy(methyl)silane are within an analogue group of substances that exhibit no evidence of significant toxicity to microorganisms.

It is therefore considered valid to read-across the results for trimethoxy(methyl)silane to fill the data gap for the registered substance.

Table 7.4.2 presents microorganism toxicity data available for substances within the sub-class of alkoxysilanes, silanols, acetoxysilanes and chlorosilanes, etc, where the Si part is of low-biological reactivity, once any hydrolysis is accounted for.

Table 7.4.2 Microorganism toxicity data available for substances within the relevant sub-class of chemicals

CAS

Name

Result: E(I)C50 (mg/l)

Result: NOEC (or EC10/ EC20) (mg/l)

Guideline Number

Test method

Species

Duration

Reliability

001000-50-6

Butylchlorodimethylsilane

>340

 

88/302/EC

ASRI

 

3h

1a

001066-40-6

Hydroxytrimethylsilane

6670

 

OECD 209 and ISO 1892

ASRI

 

Uncertain

1a

001185-55-3

Trimethoxy(methyl)silane

>100

 

OECD 209

ASRI

 

3hr

1a

031795-24-1

Potassium methylsilanetriolate

>100

 

OECD 209

ASRI

 

3 h

1a

087135-01-1

1,6-Bis(trimethoxysilyl)hexane

>1000

 

OECD 209

ASRI

 

3h

1a

017980-47-1

Triethoxyisobutylsilane

>1000

≥1000

OECD 209

ASRI

 

3h

1a

005894-60-0

Trichloro(hexadecyl)silane

>1000

 

OECD 209

ASRI

 

3h

1a

016415-12-6

Hexadecyltrimethoxysilane

>1000

 

OECD 209

ASRI

 

3 hr

1a

002943-75-1

Triethoxyoctylsilane

>1000

 

OECD 209

ASRI

 

3 hr

1a

016068-37-4

4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane

>8000

8000

DIN 38 412, Part 8 (Pseudomonas cell multiplication inhibition test)

growth inhibition test

P putida

16 h

1c

035435-21-3

Triethoxy(2,4,4-trimethylpentyl)silane

>100

 

OECD 209

ASRI

 

3hr

1a

018395-30-7

Trimethoxy(2-methylpropyl)silane

 

EC10 1.3 ml/l

Huls AG method

oxygen consumption

P putida

5.8 h

2c -don't use to derive PNEC

142877-45-0

Silane, trimethoxy(1,1,2-trimethylpropyl)-

>1000

1000

OECD 209

ASRI

 

3 hr

1a

013154-25-1

Chlorotri(3-methyl-propyl)silane

>1000

100

OECD 209

ASRI

 

3 hr

2b

126990-35-0

Dicyclopentyldimethoxysilane

>water solubility

 

OECD 209//EU C11/Huls AG method (WOE)

ASRI/ASRI/oxygen consumption P putida

 

3 hr

1a/1a/2c

139147-73-2

Silane, dichlorodicyclopentyl-

>100

 

OECD 209

ASRI

 

3 hr

1a

 

Additional information is given in a supporting report (PFA, 2013j) attached in Section 13 of the IUCLID 5 dossier.

An activated sludge respiration inhibition 3hr EC10value of >100 mg/l (loading rate) was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Desmares-Koopmans M J E,2009). This indicates that the test substance was not toxic to waste water (activated sludge) bacteria at a loading rate of 100 mg/l.

The study is considered to be reliability 1 (reliable without restrictions); the read across of the result is considered to be reliability 2 (reliable with restrictions).