Salbutamol

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:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Salbutamol

EC Number:

242-424-0

EC Name:

Salbutamol

Cas Number:

18559-94-9

Molecular formula:

C13H21NO3

IUPAC Name:

4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol

Test material form:

solid: particulate/powder

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge (adaptation not specified)

Duration of test (contact time):

28 d

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

CO2 evolution

Reference substance

Reference substance:

acetic acid, sodium salt

Results and discussion

% Degradation

% Degradation 1

Parameter:

% degradation (CO2 evolution)

Remarks:

bottle A

Value:

ca. 1.9

Sampling time:

29 d

% Degradation 2

Parameter:

% degradation (CO2 evolution)

Remarks:

bottle B

Value:

ca. 1

Sampling time:

29 d

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

Salbutamol Base was not readily biodegradable under the conditions of the modified Sturm test presently performed. However, it should be noted that in the toxicity control Salbutamol Base was found to have an inhibiting effect on microbial activity.

Executive summary:

SALBUTAMOL BASE was tested for its ready biodegradability in the carbon dioxide (C02) evolution test (modified Sturm test).

The study procedure was based on EEC directive 92/69, C.4-C, December 1992, and OECD guideline No. 301 B July 17, 1992.

Since the purity of SALBUTAMOL BASE was unknown, calculation of the theoretical TOC value was not possible. Therefore, this value was determined by analysis.

Prior to the biodegradation study the TOC concentration of a SALBUTAMOL BASE solution in milli-Q water, prepared at 1000 mg/I, was determined.

The TOC concentration of the 1000 mg/I SALBUTAMOL BASE solution was 617.5 ± 51.02 ppm.

Based on the TOC concentration the Theoretical CO2 production (ThC02) of the SALBUTAMOL BASE solution was calculated to be 2.26 mg CO2/ml.

In the modified Sturm test 39 ml of the SALBUTAMOL BASE solution was tested in 2 litres test medium, corresponding to 12 mg TOC/I.

The relative degradation values calculated from the measurements performed during the test period revealed no significant degradation of SALBUTAMOL BASE.

In the toxicity control no degradation occurred within 14 days, as well as in the whole test period (based on ThC02). Therefore, the test substance was found to have an inhibiting effect on microbial activity.

Since all acceptability criteria prescribed by the protocol were met, this study was considered to be valid.

In conclusion, SALBUTAMOL BASE was not readily biodegradable under the conditions of the modified Sturm test presently performed.

However, it should be noted that in the toxicity contral SALBUTAMOL BASE was found to have an inhibiting effect on microbial activity.