Amines, C14-16 (even numbered)-alkyldimethyl, N-oxides

Toxicity to microorganisms

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

toxicity to microorganisms

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

01-03-1990 to 20-03-1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
Please refer to the Amine Oxide Category justification attached in Section 13

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
Study summaries of the available data for category members are provided in IUCLID Section 6.1.7. These data demonstrate no real difference in toxicity to Pseudomonas putida between C12-14 AO and C12-18 AO.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: No data

Deviations:

not specified

Principles of method if other than guideline:

The quantitative reduction in the proliferation of bacteria caused by the test substance was assessed, measured as a comparison to the control in duplicate. The optical density was used.

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
No data

Analytical monitoring:

not specified

Details on sampling:

No data

Vehicle:

not specified

Details on test solutions:

No data

Test organisms (species):

Pseudomonas putida

Details on inoculum:

- Laboratory culture.

Test type:

static

Water media type:

not specified

Limit test:

no

Total exposure duration:

18 h

Post exposure observation period:

No data

Hardness:

No data

Test temperature:

No data

pH:

No data

Dissolved oxygen:

No data

Salinity:

No data

Nominal and measured concentrations:

Nominal: 0, 50, 100, 600, 10000 and 100000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 300 mL Erlenmeyer flasks
- Type: Closed
- Material, size, headspace, fill volume: 80 mL
- Aeration: Sealed
- No. of vessels per concentration: Duplicate
- No. of vessels per control: Duplicate

Reference substance (positive control):

no

Duration:

18 h

Dose descriptor:

EC10

Effect conc.:

80 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth inhibition

Duration:

18 h

Dose descriptor:

EC10

Effect conc.:

24 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth inhibition

Details on results:

No data

Results with reference substance (positive control):

No data

Reported statistics and error estimates:

No data

Bacterial toxicity of Aromox DMMCD-W by the Bringmann-Kuhn method:

Concentration Aromox DMMCD-W (mg/L)	Cell proliferation Absorbance at 420 nm
	Test series 1	Test series 2
0	0.185	0.187
50		0.155
100	0.146	0.156
600		0.079
1000	0.056	0.056
10000	0.040
100000	0.020

Validity criteria fulfilled:

not specified

Conclusions:

The EC10 of AROMOX DMMCD-W was determined to be 80 mg/L.

Reference 2

Endpoint:

toxicity to microorganisms

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25-03-1992 to 26-03-1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: German Standard Method DIN 38 412

Deviations:

not specified

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 126 deg C
- Boiling point: n/a
- Vapour pressure: 1.7E-06 and 7.5E-05 Pa
- Water solubility: 409 g/L
- Henry's law constant: 3.7E-09-1.2E-08 Pa m³/mol
- log Pow: <2.7
- pKa: 4.01
- Stability in water: stable
- Stability in light: stable
- pH dependance on stability: n/a

OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: readily biodegradable

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

Pseudomonas putida

Test type:

static

Water media type:

not specified

Limit test:

no

Total exposure duration:

16 h

Duration:

16 h

Dose descriptor:

EC10

Effect conc.:

76 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth inhibition

Duration:

16 h

Dose descriptor:

EC50

Effect conc.:

188.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth inhibition

Duration:

16 h

Dose descriptor:

EC100

Effect conc.:

588 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth inhibition

Duration:

16 h

Dose descriptor:

EC10

Effect conc.:

22.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth inhibition

Validity criteria fulfilled:

yes

Remarks:

the test substance and the contol were in the prescribed ranges.

Conclusions:

The toxicity of the test substance was assessed in a cell multiplication inhibition test using Pseudomonas putida according to the German Standard Method DIN 38 412. The EC50 after 16 h was 188.7 mg/L.

Reference 3

Endpoint:

toxicity to microorganisms

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

The quantitative reduction in the proliferation of bacteria caused by the test substance was assessed, measured as a comparison to the control in duplicate. The optical density was used.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Pseudomonas putida

Details on inoculum:

laboratory culture

Test type:

static

Water media type:

not specified

Limit test:

no

Total exposure duration:

18 h

Nominal and measured concentrations:

0, 50, 100, 1000, 10000, 100000 mg/L based on test substance

Duration:

18 h

Dose descriptor:

EC10

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth inhibition

Duration:

18 h

Dose descriptor:

EC10

Effect conc.:

29.8 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth inhibition

Details on results:

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: none

Description of key information

No studies investigating the toxicity to micro-organisms have been performed using C14-16 AO. Data are available for category members C12 -14 AO and C12 -18 AO.

C12-14 AO and C12-18 AO exhibit similar toxicity to Pseudomonas putida. The value of 24 mg AO/L from a study with C12-14 AO is used for the chemical safety assessment for C14-16 AO.

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:

24 mg/L

Additional information

No studies investigating the toxicity to micro-organisms have been performed using C14-16 AO. Data are available for category members C12-14 and C12-18 AO.

Two reliable studies are available for C12 -14 AO. In the key study, Pseudomonas putida were exposed to nominal concentrations of 0, 50, 100, 600, 1000, 10000 or 100000 mg/L of C12 -14 AO for 18 hours in a Bringmann-Kohn test [Kolvenbach M (1990)]. The EC10, based on reduction in growth rate, was 24 mg AO/L.

In a study performed using C12 -18 AO Pseudomonas putida were exposed to nominal concentrations of 0, 50, 100, 1000, 10000 or 100000 mg/L test substance for18 hours in a Bringmann-Kohn test [Kolvenbach M (1990)]. The EC10, based on reduction in growth rate, was 29.8 mg/L.