Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Toxicity to microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Neither the results nor the methods were clearly presented or explained. Concentrations greater than 320 mg/L could not be tested.
Qualifier:
equivalent or similar to guideline
Guideline:
DIN 38412-8 (Pseudomonas Zellvermehrungshemmtest)
Deviations:
not specified
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Pseudomonas putida
Test type:
static
Water media type:
not specified
Limit test:
no
Total exposure duration:
18 h
Details on test conditions:
Type: other: liquid broth cultures
Reference substance (positive control):
no
Key result
Duration:
18 h
Dose descriptor:
EC10
Effect conc.:
> 320 mg/L

Nominal Test Concentrations: 0.23, 0.46, 0.93, 1.87, 3.75, 7.50, 15.00, 30.00, 60.00, 120.00, 240.00, 320.00 mg/L. The inhibition concentration was >320 mg C/L. Higher concentrations appeared to stimulate bacterial growth indicating it was an energy source. Bisphenol A had a low solubility and as a result an exact inhibitory concentration could not be determined. Researchers attempted to increase BPA concentrations by dissolving the compound in dimethyl formamide but it precipitated out again when the BPA solution was mixed with the culture medium preventing a turbidimetric determination from being made.

Validity criteria fulfilled:
not specified
Conclusions:
The biodegradability of Bisphenol A in liquid broth culture to Pseudomonas putida was studied. In this study, an EC10 of >320 mg/L was reported. While this study is not the same as the activated sludge respiration test that would typically be performed to satisfy this data need, Bisphenol A is readily biodegradable and does not show high toxicity to microbial populations. The Weight of Evidence suggests that no additional studies are necessary for the assessment of microbial populations exposed to Bisphenol A.
Executive summary:

The biodegradability of Bisphenol A in liquid broth culture to Pseudomonas putida was studied. In this study, an EC10 of >320 mg/L was reported. While this study is not the same as the activated sludge respiration test that would typically be performed to satisfy this data need, Bisphenol A is readily biodegradable and does not show high toxicity to microbial populations. The Weight of Evidence suggests that no additional studies are necessary for the assessment of microbial populations exposed to Bisphenol A.

Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study method details are lacking.
Principles of method if other than guideline:
Method: 79/931/EEC, Annex V of the 6th Amendment
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Pseudomonas fluorescens
Test type:
not specified
Water media type:
not specified
Limit test:
no
Total exposure duration:
16 h
Details on test conditions:
Type: aquatic
Reference substance (positive control):
not specified
Key result
Duration:
16 h
Dose descriptor:
IC50
Effect conc.:
54.5 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
growth inhibition

The IC50 of the control was 7 mg/L. The IC50 for inhibition with BPA was 54.5 mg/L.

Validity criteria fulfilled:
not specified
Conclusions:
The biodegradability of Bisphenol A was studied in a number of tests. One of them evaluated the inhibition of growth of the bacteria, Pseudomonas fluorescens. In this microbial inhibition test, the IC50 for the inhibition of growth of Pseudomonas by Bisphenol A was 54.5 mg/L.
Executive summary:

The biodegradability of Bisphenol A was studied in a number of tests. One of them evaluated the inhibition of growth of the bacteria, Pseudomonas fluorescens. In this microbial inhibition test, the IC50 for the inhibition of growth of Pseudomonas by Bisphenol A was 54.5 mg/L. While this study is not the same as the activated sludge respiration test that would typically be performed to satisfy this data need, Bisphenol A is readily biodegradable and does not show high toxicity to microbial populations. The Weight of Evidence suggests that no additional studies are necessary for the assessment of microbial populations exposed to Bisphenol A.

Description of key information

Two studies are available which were rated with Klimisch 2 (reliable, with restrictions) were used in a weight-of-evidence (WoE) approach to derive PNEC STP. Fabig (1988) reported an 18 h-EC10 of > 320 mg/L (highest test concentration) with Pseudomonas putida. This study is not the same as an activated sludge respiration test according to OECD 209 but there is indication of no toxicity towards P. putida as a microorganism.

Stone and Watkinson (1983) as well is not an OECD 209 study but investigated biodegradation with a bacteria growth inhibition test with Pseudomonas fluorescens. The IC50 was reported as 54.4 mg/L.

Both studies were used in a WoE approach. The REACH guidance document R.10 specifies that studies with P. fluorescens are of limited relevance for STP as this species uses glucose as substrate. However, a growth inhibition test with P. putida may be used for PNEC STP derivation. The study of Fabig (1988) was conducted in accordance with DIN 38412-8 while the recent REACH guidance document R.10 asks for ISO-10712 (1996). Despite the fact that it is not totally certain if the DIN translated directly into the ISO the study is considered sufficiently reliable to be used in a WoE approach. Thus, the EC10 > 320 mg/L was used for PNEC derivation. This approach was also taken in the European Risk Assessment report (2010).

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:
320 mg/L

Additional information