Guanidine, N-phenyl-, compd. with carbonic acid, hydrate (2:1:2)

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - August 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

reliable with restrictions: GLP Guideline study according to OECD 301B; in deviation from the Guideline the volume of the test solution was reduced from 3.0l to 1.5l. The CO2 formed by biodegradation was absorbed with NaOH and determined on a carbon analyzer. The test was conducted without abiotic steril control and toxicity control. These restrictions are acceptable and do not impair the overall conclusion from the data.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

The volume of the test solution was reduced from 3.0l to 1.5l. The CO2 formed by biodegradation was absorbed with NaOH and determined on a carbon analyzer.

GLP compliance:

yes

Remarks:

This study has been performed in compliance with GLP in Switzerland, Procedures and Pronciples, March 1986, issued by the Swiss federal Department of the Interior and the Intercantonal Office for the Control of Medicaments.

Oxygen conditions:

aerobic

Inoculum or test system:

other: bacteria collected from sewage treatment plant

Duration of test (contact time):

28 d

Initial conc.:

11.1 mg/L

Based on:

test mat.

Initial conc.:

20 mg/L

Based on:

test mat.

Key result

Parameter:

% degradation (CO2 evolution)

Value:

8

Sampling time:

28 d

Remarks on result:

other: test with 11.1 mg/L test substance

Parameter:

% degradation (CO2 evolution)

Value:

7

Sampling time:

28 d

Remarks on result:

other: test with 20 mg/L test substance

Details on results:

Reference substance (Aniline MERCK No.: 1261) showed ready biodegradability.

Validity criteria fulfilled:

yes

Remarks:

criteria: aniline degradation (positive control) at day 28: 96 %; percentage degradation of positive control has reached pass level by day 14; difference between replicates < 20%; CO2 evolution in inoculum blanks does not exceed 40 mg/L

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

CA 1139 A is not biodegradable under the conditions of this test.

Executive summary:

The ready biodegradabilty of CA 1139 A was determined in a 28 day CO₂Evolution Test, according to GLP Guideline OECD 301B, under aerobic conditions in dark brown glass vessels at room temperature (22 ± 2 ºC). The experiment was conducted in compliance with Good Laboratory Pratice (GLP) in, Procedures and Principles, March 1986, issued by the Federal Department of the interior and the Intercantonal Office for the Control of Medicaments,.

The test substance was tested in concentrations of 11.1 and 20.0 mg/l test substance. The reference substance was tested at a concentration of 20.0 mg/l.

The test system consisted of bacteria collected from a sewage treatment plant. The preparation was carried out according to guideline.

The degradation was followed by analysis of CO₂evolution at frequent intervals over a period of 28 days. Aniline served as positive control. The degree of biodegradation was calculated on the basis of the theoretical carbon content of the test substance and the cumulative quantities of CO2 determined on the days of measurements. 

The mean value of the biodegradation of CA 1139 A after 28 days was 7.5 %. The Biodegradation of the reference substance after 28 days was 96 %.

On the basis of the present study CA 1139 A is not readily biodegradable.

Description of key information

The ready biodegradabilty of CA 1139 A was determined in a 28 day CO2Evolution Test,

according to GLP Guideline OECD 301B, under aerobic conditions in dark brown glass vessels at room temperature (22 ± 2 ºC). The experiment was conducted in compliance with Good Laboratory Pratice (GLP) in, Procedures and Principles, March 1986, issued by the Federal Department of the interior and the Intercantonal Office for the Control of Medicaments,.
The test substance was tested in concentrations of 11.1 and 20.0 mg/l test substance. The reference substance was tested at a concentration of 20.0 mg/l.
The test system consisted of bacteria collected from a sewage treatment plant. The preparation was carried out according to guideline.
The degradation was followed by analysis of CO2evolution at frequent intervals over a period of 28 days. Aniline served as positive control. The degree of biodegradation was calculated on the basis of the theoretical carbon content of the test substance and the cumulative quantities of CO2 determined on the days of measurements. 
The mean value of the biodegradation of CA 1139 A after 28 days was 7.5 %. The Biodegradation of the reference substance after 28 days was 96 %.
On the basis of the present study CA 1139 A is not readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed

Additional information

 

Guideline Test Type	Species	Ready Biodegradability	Reference	Reliability
OECD 301B	bacteria collected from sewage treatment plant	no	Baumann, W., Ciba-Geigy, 1992	Reliable with restrictions