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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Short term toxicity study to Fathead Minnow (Pimephales promelas) was carried out for 96 hrs.
The objective of this study was to develop procedures that relate modes of acute toxic action in the fathead minnow (Pimephales promelas) to chemical structures and properties. An empirically derived database for diverse chemical structures of acute toxicity and corresponding modes of toxic action was developed through joint toxic action studies, the establishment of toxicodynamic profiles, and behavioral and dose–response interpretation of 96-h LC50 tests.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Nonanone
- Molecular formula (if other than submission substance): C9H18O
- Molecular weight (if other than submission substance): 142.2402 g/mol
- Smiles notation (if other than submission substance): C(CCCCC)CC(C)=O
- InChI: 1S/C9H18O/c1-3-4-5-6-7-8-9(2)10/h3-8H2,1-2H3
- Substance type: Organic
- Physical state: Liquid
Analytical monitoring:
yes
Details on sampling:
No data available
Vehicle:
not specified
Details on test solutions:
No data available
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead Minnow
- Strain: No data available
- Source: No data available
- Age at study initiation (mean and range, SD): 28 – 36 d old juveline test fish was used for the study.
- Length at study initiation (length definition, mean, range and SD): No data available
- Weight at study initiation (mean and range, SD): No data available
- Method of breeding: No data available
- Feeding during test: No data available
- Food type: No data available
- Amount: No data available
- Frequency: No data available

ACCLIMATION
- Acclimation period: No data available
- Acclimation conditions (same as test or not): No data available
- Type and amount of food: No data available
- Feeding frequency: No data available
- Health during acclimation (any mortality observed): No data available

QUARANTINE (wild caught)
- Duration: No data available
- Health/mortality: No data available
Test type:
flow-through
Water media type:
freshwater
Total exposure duration:
96 h
Post exposure observation period:
No data available
Hardness:
No data available
Test temperature:
25 ± 1°C
pH:
No data available
Dissolved oxygen:
No data available
Salinity:
No data available
Nominal and measured concentrations:
Measured concentration
Details on test conditions:
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Lake Superior Water


Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
15.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% confidence interval
Details on results:
- Behavioural abnormalities: The behavior stress syndrome shown by test organism exposed to test chemical was of Type 1 behaviour syndrome. Fish showing type I behavior had depressed locomotor activity with little or no response to outside stimuli. Body coloration became darker with most fish dying within 24 h.
- Observations on body length and weight: No data available
- Other biological observations: No data available
- Mortality of control: No data available
- Other adverse effects control: No data available
- Abnormal responses: No data available
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No data available
- Effect concentrations exceeding solubility of substance in test medium: No data available
Results with reference substance (positive control):
No data available
Reported statistics and error estimates:
No data available
Sublethal observations / clinical signs:

Each mode of action classification was assigned a level of confidence based on the type of data used when making the assessment; confidence levels were high (Level A using FATS and joint toxic action data), moderate (Level B using behavior syndrome, LC50 ratios, Te values, and structural similarity to Level A compounds), and low (Level C using behavioral comments, concentration/response slope, and structural similarity within a chemical class).

 

The mode of action for the test chemical is Narcosis I: Level B confidence.

Validity criteria fulfilled:
not specified
Conclusions:
Short term toxicity study to Fathead Minnow (Pimephales promelas) was carried out for 96 hrs. Based on mortality, the 96 hr LC50 value for Fathead Minnow (Pimephales promelas) was found to be 15.2 mg/l.
Executive summary:

Short term toxicity study of test chemical 2-Nonanone to Fathead Minnow (Pimephales promelas) was carried out for 96 hrs.

 

The objective of this study was to develop procedures that relate modes of acute toxic action in the fathead minnow (Pimephales promelas) to chemical structures and properties. An empirically derived database for diverse chemical structures of acute toxicity and corresponding modes of toxic action was developed through joint toxic action studies, the establishment of toxicodynamic profiles, and behavioral and dose–response interpretation of 96-h LC50 tests.

 

Chemicals in the fathead minnow database were evaluated through analyses of dose–response relationships and behavioral responses associated with 96-h LC50 bioassays. Based on the amount of available information for a test compound, a level of confidence was assigned to a mode of action determination.

 

28 - 30 d old juveline test organisms were used for the study. The test was performed under flowthrough condition with temp. of 25 ± 1°C.

 

Test was conducted using Lake Superior water at 25±1°C.Aqueous toxicant concentrations were measured in tests with quality assurance criteria requiring 80% agreement between duplicate samples and 90 to 110% spike recovery. Flow-through exposures were conducted using cycling proportional, modified Benoit, or electronic diluters. Tests conducted which were conducted on the Benoit and electronic diluters did not have replicate tank exposures.

Median lethal concentration (LC50) was calculated using the Trimmed Spearman–Karber Method, with 95% confidence intervals being calculated when possible.

 

The change of LC50 values over time (LC50 ratio) and the ratio of measured 96-h LC50 values to those predicted from a baseline narcosis (narcosis I) QSAR were used as supportive data for assessing potential modes of action. Each mode of action classification was assigned a level of confidence based on the type of data used when making the assessment; confidence levels were high (Level A using FATS and joint toxic action data), moderate (Level B using behavior syndrome, LC50 ratios, Te values, and structural similarity to Level A compounds), and low (Level C using behavioral comments, concentration/response slope, and structural similarity within a chemical class).

 

Thus, the mode of action for the test chemical was Narcosis I: Level B confidence alongwithtype 1 behaviour syndrome. Test organism had showed depressed locomotor activity with little or no response to outside stimuli. Body coloration became darker with most fish dying within 24 h.

 

Based on mortality, the 96 hr LC50 value for Fathead Minnow (Pimephales promelas) was found to be 15.2 mg/l.These experimental lethal concentration suggest that test chemical 2-Nonanone is toxic to fish and thus classified in aquatic category 3 as per the CLP criteria.

Description of key information

Short term toxicity study of test chemical2-Nonanoneto Fathead Minnow (Pimephales promelas) was carried out for 96 hrs.

 

The objective of this study was to develop procedures that relate modes of acute toxic action in the fathead minnow (Pimephales promelas) to chemical structures and properties. An empirically derived database for diverse chemical structures of acute toxicity and corresponding modes of toxic action was developed through joint toxic action studies, the establishment of toxicodynamic profiles, and behavioral and dose–response interpretation of 96-h LC50 tests.

 

Chemicals in the fathead minnow database were evaluated through analyses of dose–response relationships and behavioral responses associated with 96-h LC50 bioassays. Based on the amount of available information for a test compound, a level of confidence was assigned to a mode of action determination.

 

28 - 30 d old juveline test organisms were used for the study. The test was performed under flowthrough condition with temp. of 25 ± 1°C.

 

Test was conducted using Lake Superior water at 25±1°C.Aqueous toxicant concentrations were measured in tests with quality assurance criteria requiring 80% agreement between duplicate samples and 90 to 110% spike recovery. Flow-through exposures were conducted using cycling proportional, modified Benoit, or electronic diluters. Tests conducted which were conducted on the Benoit and electronic diluters did not have replicate tank exposures.

Median lethal concentration (LC50) was calculated using the Trimmed Spearman–Karber Method, with 95% confidence intervals being calculated when possible.

 

The change of LC50 values over time (LC50 ratio) and the ratio of measured 96-h LC50 values to those predicted from a baseline narcosis (narcosis I) QSAR were used as supportive data for assessing potential modes of action. Each mode of action classification was assigned a level of confidence based on the type of data used when making the assessment; confidence levels were high (Level A using FATS and joint toxic action data), moderate (Level B using behavior syndrome, LC50 ratios, Te values, and structural similarity to Level A compounds), and low (Level C using behavioral comments, concentration/response slope, and structural similarity within a chemical class).

 

Thus, the mode of action for the test chemical was Narcosis I: Level B confidence alongwithtype 1 behaviour syndrome. Test organism had showed depressed locomotor activity with little or no response to outside stimuli. Body coloration became darker with most fish dying within 24 h.

 

Based on mortality, the 96 hr LC50 value for Fathead Minnow (Pimephales promelas) was found to be 15.2 mg/l.These experimental lethal concentration suggest that test chemical2-Nonanone is toxic to fish and thus classified in aquatic category 3 as per the CLP criteria.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
15.2 mg/L

Additional information

Four different studies which includes two experimental from peer reviewed journal and study report and remaining two from validated predicted model for short term fish toxicity endpoint for target chemical 2-Nonanone (Cas no. 821-55-6) are summarized as followed:

First experimental study suggest Short term toxicity study of test chemical 2-Nonanone to Fathead Minnow (Pimephales promelas) was carried out for 96 hrs. The objective of this study was to develop procedures that relate modes of acute toxic action in the fathead minnow (Pimephales promelas) to chemical structures and properties. An empirically derived database for diverse chemical structures of acute toxicity and corresponding modes of toxic action was developed through joint toxic action studies, the establishment of toxicodynamic profiles, and behavioral and dose–response interpretation of 96-h LC50 tests.Chemicals in the fathead minnow database were evaluated through analyses of dose–response relationships and behavioral responses associated with 96-h LC50 bioassays. Based on the amount of available information for a test compound, a level of confidence was assigned to a mode of action determination.28 - 30 d old juveline test organisms were used for the study. The test was performed under flowthrough condition with temp. of 25 ± 1°C.

Median lethal concentration (LC50) was calculated using the Trimmed Spearman–Karber Method, with 95% confidence intervals being calculated when possible. The change of LC50 values over time (LC50 ratio) and the ratio of measured 96-h LC50 values to those predicted from a baseline narcosis (narcosis I) QSAR were used as supportive data for assessing potential modes of action. Each mode of action classification was assigned a level of confidence based on the type of data used when making the assessment; confidence levels were high (Level A using FATS and joint toxic action data), moderate (Level B using behavior syndrome, LC50 ratios, Te values, and structural similarity to Level A compounds), and low (Level C using behavioral comments, concentration/response slope, and structural similarity within a chemical class). Thus, the mode of action for the test chemical was Narcosis I: Level B confidence alongwithtype 1 behaviour syndrome. Test organism had showed depressed locomotor activity with little or no response to outside stimuli. Body coloration became darker with most fish dying within 24 h. Based on mortality, the 96 hr LC50 value for Fathead Minnow (Pimephales promelas) was found to be 15.2 mg/l.This experimental lethal concentration suggest that test chemical 2-Nonanone is toxic to fish and thus classified in aquatic category 3 as per the CLP criteria.

Other Experimental study give assistance to above experimental result i.e the short term toxicity study was conducted to test the effect of 2 - nonanone on fathead minnows in a flow through conditions. The nominal concentration used were 0, 7.67, 11.8, 18.1, 27.8, or 42.8 mg/L.Affected fish lost schooling behaviour, swam near tank bottom, and were hypoactive. Fish were darkly colored, had increased respiration, and lost equilibrium prior to death. Mortalities at 96 hrs: 27.8 mg/L 20/20; 42.8 mg/L, 20/20. No mortalities at lower concentrations.

Therefore LC50 of 2-nonanone in fathead minnows in a flow-through system was found to be 15.2 mg/L for 96 hour.

Lethal concentration by Predicted database Danish QSAR (Database developed by National Food Institute, Technical University of Denmark, with support from the Danish Environmental Protection Agency, the Nordic Council of Ministers and the European Chemicals Agency, 2017) indicate based on mortality, the estimated 96 hrs LC50 value by three different model i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database was found to be 13.194 mg/l.

And another predicted model by EPI Suite ECOSAR version 1.10 indicate the 96 hours LC50 was estimated to be 26.825 mg/l on Fish for substance 2-Nonanone (CAS no.821-55-6) on the basis of mortality effects. 

Above all experimental and predicted values for median lethal dose concentration(LC50) is in the range of 13.194 -26.825 mg/l conclude the target chemical 2-Nonanone (Cas no. 821-55-6) is is toxic to fish and thus classified in aquatic category 3 as per the CLP criteria.