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Toxicity to microorganisms

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Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to
Guideline:
other: CIBA Method B-10
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
None
Analytical monitoring:
yes
Details on sampling:
None
Vehicle:
not specified
Details on test solutions:
None
Test organisms (species):
activated sludge
Details on inoculum:
None
Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
None
Test temperature:
None
pH:
None
Dissolved oxygen:
None
Salinity:
None
Conductivity:
None
Nominal and measured concentrations:
None
Details on test conditions:
None
Reference substance (positive control):
not specified
Key result
Duration:
21 d
Dose descriptor:
IC50
Effect conc.:
> 300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Details on results:
None
Results with reference substance (positive control):
None
Reported statistics and error estimates:
None

None

Validity criteria fulfilled:
not specified
Conclusions:
The IC50 for FAT 40000/D was found to be greater than 300 mg/l.
Executive summary:

The toxicity of FAT 40000/D to activated sludge was determined in a 3-hours respiration inhibition test according to CIBA Method B-10. Based on the findings of the study, the IC50 of the test substance FAT 40000/D is greater than 300 mg/l.

Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to
Guideline:
other: CIBA Method B-10
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
None
Analytical monitoring:
yes
Details on sampling:
None
Vehicle:
not specified
Details on test solutions:
None
Test organisms (species):
activated sludge
Details on inoculum:
None
Test type:
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
None
Test temperature:
None
pH:
None
Dissolved oxygen:
None
Salinity:
None
Conductivity:
None
Nominal and measured concentrations:
None
Details on test conditions:
None
Reference substance (positive control):
not specified
Key result
Duration:
21 d
Dose descriptor:
IC50
Effect conc.:
> 300 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Details on results:
None
Results with reference substance (positive control):
None
Reported statistics and error estimates:
None

None

Validity criteria fulfilled:
not specified
Conclusions:
The IC50 for FAT 40000/E was found to be greater than 300 mg/l.
Executive summary:

The toxicity of FAT 40000/E to activated sludge was determined in a 21 days respiration inhibition test according to CIBA Method B-10. Based on the findings of the study, the IC50 of the test substance FAT 40000/E is greater than 300 mg/l.

Endpoint:
toxicity to microorganisms, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test
Deviations:
yes
Remarks:
1. Deion. water instead of dest. water for the stocksolution 2. Preparation of the inoculum :higher sludge weight after the washing procedure (Sludge concentrations in the test according to the guidelines) 3. 4 instead of 5 test concentrations
Principles of method if other than guideline:
None
GLP compliance:
yes
Specific details on test material used for the study:
None
Analytical monitoring:
yes
Details on sampling:
None
Vehicle:
not specified
Details on test solutions:
None
Test organisms (species):
other: Activated sludge of a communal sewage treatment plant
Details on inoculum:
3 times washing with tap water and addition of synthetic sewage (a day before the main test)
Test type:
other:
Water media type:
freshwater
Limit test:
no
Total exposure duration:
3 h
Remarks on exposure duration:
None
Post exposure observation period:
None
Hardness:
None
Test temperature:
20.6 °C
pH:
7.8 before the test beginning
Dissolved oxygen:
None
Salinity:
None
Conductivity:
None
Details on test conditions:
320,100, 32 and 10 mg/l of the test substance
32,10 and 3.2 mg/l of the reference substance
Reference substance (positive control):
yes
Remarks:
3,5-Dichlorophenol
Key result
Duration:
3 h
Dose descriptor:
IC50
Effect conc.:
> 320 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Details on results:
None
Results with reference substance (positive control):
The IC50 for3,5- dichlorophenol was found to be 13.5 mg/L.
Reported statistics and error estimates:
None

None

Validity criteria fulfilled:
yes
Conclusions:
The IC50 for FAT 40000/G was found to be greater than 320 mg/L.
Executive summary:

The toxicity of FAT 40000/G to activated sludge was determined in a 3-hours respiration inhibition test according to the OECD Guideline No. 209, and to the EG Method Nr.L 133/118. The test substance concentrations tested were 320,100, 32 and 10 mg/l. The reference substance 3,5-Dichlorophenol was tested in concentrations of 32,10 and 3.2 mg/l. The IC50 for reference substance was found to be 13.5 mg/L. Based on the findings, the IC50 for FAT 40000/G was found to be greater than 320 mg/L

Endpoint:
activated sludge respiration inhibition testing
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the source and the target substance have very similar physicochemical and (eco)toxicological properties because their chemical structures are nearly identical. An analogue approach has thus been employed. The target substance is the meta-isomer of the dye Reactive Yellow 095, where the sulphonate group is bound at the meta-position of the amino benzene moiety. The source chemical is the reaction mass of both the meta-isomer and the para-isomer of Reactive Yellow 095.
The presence of sulphonate groups make both dyes highly water soluble and therefore less critical for human health and environmental issues. Based on their chemical similarity, similar properties are expected in both humans and the environment.
2. SOURCE AND TARGET CHEMICAL(S)
Source: Reactive Yellow 095 meta/para (CAS# --- / EC# 944-218-2)
Target: Reactive Yellow 095 meta (CAS# 84045-63-6 / EC# 281-865-3)
3. ANALOGUE APPROACH JUSTIFICATION
see attachment under 4.12 Auto flammability
Reason / purpose:
read-across source
Duration:
3 h
Dose descriptor:
IC50
Effect conc.:
> 320 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth inhibition
Validity criteria fulfilled:
yes
Conclusions:
The 3h-IC50 in microorganisms (activated sludge) was determined to be >320 mg/L.
Executive summary:

The toxicity of the source substance to activated sludge was determined in a 3-hours respiration inhibition test according to the OECD Guideline No. 209. The test substance concentrations tested were 320,100, 32 and 10 mg/l. The reference substance 3,5-Dichlorophenol was tested in concentrations of 32,10 and 3.2 mg/l. The IC50 for the reference substance was found to be 13.5 mg/L. Based on the findings, the IC50 for the source substance was found to be greater than 320 mg/L

The structurally related target substance will show the same behaviour and therefore it is anticipated that the 3h-IC50 will also be >320 mg/L.

Description of key information

The 3h-IC50 in microorganisms (activated sludge) was determined to be greater than 320 mg/L.

Key value for chemical safety assessment

EC50 for microorganisms:
320 mg/L
EC10 or NOEC for microorganisms:
320 mg/L

Additional information

The toxicity of the source substance to activated sludge was determined in a 3-hour respiration inhibition test according to OECD Guideline 209. Based on the findings of the study, the IC50 of the source substance is greater than 320 mg/L. Two supporting studies involving different batches of the source substance have been conducted. Similar results were achieved.

The structurally related target substance will show the same behaviour and therefore it is anticipated that the 3h-IC50 will also be >320 mg/L.