2,4-Dibromo-6-[(cyclohexyl-methyl-amino)-methyl]-phenylamine hydrobromide

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13.01.2003 - 09.04.2003

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide

EC Number:

617-191-7

Cas Number:

81060-07-3

Molecular formula:

C14H20Br2N2 x HBr

IUPAC Name:

2,4-dibromo-6-{[cyclohexyl(methyl)amino]methyl}aniline hydrobromide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Bromhexine Hydrobromide
- Physical state: white powder
- Lot/batch No.: 02070864
- Expiration date of the lot/batch: Retest date: June 2003
- Storage condition of test material: At room temperature, aired rooms

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, adapted

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): wastewater treatment plant
(ARA Ergolz II, Füllinsdorf, Switzerland) treating predominantly domestic wastewater.
- Pretreatment: The sludge was washed twice with tap water by centrifugation and the supernatant liquid phase
was decanted.
- Concentration of sludge: 30 mg dry material per Iiter

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

100 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Reference substance

Reference substance:

benzoic acid, sodium salt

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

ca. 0

Sampling time:

28 d

Remarks on result:

other: The biochemical oxygen demand (800) of the test item Bromhexine Hydrobromide in the test media was within the range of the inoculum controls

BOD5 / COD results

Results with reference substance:

ln the procedure controls, the reference item was degraded by an average of 85% by
exposure Day 14, thus confirming suitability of the activated sludge. At the end of the test
(Day 28), the reference item was degraded by an average of 93%.

Any other information on results incl. tables

Toxicity control: The percent biodegradation in the toxicity control containing both the test item and the reference item was calculated based on the ThOD of the test item (ThOD_NH4 or ThOD_NO3) and the reference item.

The biodegradation rate in the toxicity control showed a similar course of biodegradation over the 28-day exposure period as the two procedure controls containing the reference item, only. Within 14 days of exposure, a biodegradation rate of 48% and 44% was observed based on the ThOD_NH4 and the ThOD_NO3 respectively.

Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms because the biodegradation rate in the toxicity control was >25% within 14 days.

Abiotic control: No degradation of the test item occurred in the abiotic control under the test conditions.

Inoculum controls: The biochemical oxygen demand (800) of the test item Bromhexine Hydrobromide in the test media was within the range of the inoculum controls

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

The biochemical oxygen demand (BOD) of the test item Bromhexine Hydrobromide in the
test media was within the range of the inoculum controls.
Consequently, Bromhexine Hydrobromide was found to be not biodegradable under the test
conditions within 28 days.
ln the toxicity control, containing both Bromhexine Hydrobromide and the reference item
sodium benzoate, no inhibitory effect on the biodegradation of the reference item was
determined. Thus, Bromhexine Hydrobromide had obviously no inhibitory effect on the
activity of activated sludge microorganisms.
ln the procedure controls, the reference item sodium benzoate was biodegraded by an
average of 85% on exposure Oay 14, and reached an average biodegradation rate of 93%
by the end of the test (Oay 28), thus confirming suitability of the activated sludge.