Registration Dossier

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:
key study
Study period:
01-05-2017 - 13-05-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental result performed using standard methods of analysis
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-methylpiperidin-4-ol
- Molecular formula: C6H13NO
- Molecular weight: 115.175 g/mol
- Substance type: Organic
- Physical state: colourless to pale yellow liquid

SOURCE OF TEST MATERIAL
- Batch No.of test material: CNMHP/RD/17001
- Expiration date of the lot/batch: 20-07-17
- Purity test date: 99.73%(by GC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient Temp (23 to 27 °C) (Keep container tightly closed in a dry & well-ventilated place. Store in cool place. Do not expose to air, light & moisture.)
- Stability under test conditions: Stable in recommended storage conditions
- Solubility in Water: 105579.95 mg/L

Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
Preparation of the test Solutions : The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 400 mg of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous 1 hour stirring for achieving test concentrations of 100mg/L ,respectively.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Fishes, to be used in the study, are kept in the test water for seven days immediately before testing under following conditions:
Photoperiod: 16 hours light and 8 hours dark
Temperature range: 23.3 °C
pH range: 7.62
DO range: 7.7 mg/l
Feeding: Daily once
Aeration: Continuous
Mortality (%) During last 48 hours = 0
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
148.5 mg of CaCO3
Test temperature:
23 °C
pH:
7.02
Dissolved oxygen:
7.7 mg/l
Nominal and measured concentrations:
100mg/L
Details on test conditions:
Photoperiod: 16 hours light and 8 hours dark
Volume of water: 2 liters
No. of animals per vessel: 8 fishes
Test temperature: 23 °C
Adaptation: Test conditions corresponded to housing conditions
Test dates: Test started at : 01-05-2017
Test Exposure date: 09-05-2017
Date of experimental termination : 13-05-2017
Withdrawal of food: 1 day before and during exposure
Aeration: Aeration in test vessels was provided 1 day before the start of experiment
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Mortality and symptoms:

Nominal

Concentration

(mg/l)

Number of

fish

Mortality (cumulated) after

3 h

6 h

24 h

48 h

72 h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

-

-

-

-

-

-

-

-

-

-

-

-

100

4

4

-

-

-

-

-

-

-

-

-

-

-

-

 

Visible Symptoms:

Nominal

Concentration

(mg/l)

Number of

fish

Symptom (cumulated) after

3 h

6 h

24 h

48 h

72 h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

100

4

4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

NS4

 

Explanation of symptoms:

A: apathy

N: Narcotic-like state

C: Swimming near water surface

M: Slow movements compared to control

NS: No abnormal symptoms

S: Surfacing behaviour

L: Loss of equilibrium

SM: Shimming movement

H1: Hyperactivity

H2: Hypo activity

B: Bending behavior

F: Fin rot

IS: Invert Swimming

SB: Swimming behaviour

RF: Respiratory Function

P: Pigmentation

 

pH and oxygen content:

Nominal

Concentration

(mg/l)

Number of

fish

pH readings after

24 h

48 h

72 h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

8.17

8.21

8.17

8.16

7.78

7.81

7.80

7.81

100

4

4

8.21

8.20

8.39

8.38

8.33

8.32

8.30

8.31

 

Nominal

Concentration

(mg/l)

Number of

fish

Oxygen content (mg/L) after

24 h

48 h

72 h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

6.8

6.8

6.7

6.8

6.6

6.6

6.5

6.5

100

4

4

7.0

7.0

7.0

7.0

6.9

6.9

6.8

6.8

 

Test temperature:

Nominal

Concentration

(mg/l)

Number of

fish

Oxygen content (mg/L) after

24 h

48 h

72 h

96 h

V1

V2

V1

V2

V1

V2

V1

V2

Control

4

4

22.9

22.9

23.5

23.5

23.9

23.9

23.5

23.5

100

4

4

22.8

22.8

23.6

23.6

23.9

23.9

23.6

23.6

Validity criteria fulfilled:
yes
Conclusions:
Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for CAS No. 106-52-5 on Zebra fish(Danio rerio)was found to be >100 mg/L.
Executive summary:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for (test item name) 1-methylpiperidin-4-ol. The nominal concentration selected for the experiment were 100mg/Land test fish were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L LC0 (96 hours) (highest loading at which no mortality was observed) = 100 mg/L LC50 (96 hours) Experimental = >100 mg/L LC100 (96 hours) (lowest loading at which 100% mortality was observed) = No mortality was observed. This value indicates that the substance 1-methylpiperidin-4-ol can be considered as not classified under short term toxicity to fish category.

Description of key information

Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for CAS No. 106-52-5 on Zebra fish (Danio rerio)was found to be >100 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

Experimental study result and predicted model data for the test chemical 1-methylpiperidin-4-ol (CAS No. 106-52-5) with respective read across were reviewed to summarize the following information:

In key study, Fish Acute Toxicity test according to OECD Guideline 203 was conducted for (test item name) 1-methylpiperidin-4-ol. The nominal concentration selected for the experiment were 100mg/Land test fish were exposed to these concentration for 96 hours. The lethal concentrations LC50 was found to be >100 mg/L LC0 (96 hours) (highest loading at which no mortality was observed) = 100 mg/L LC50 (96 hours) Experimental = >100 mg/L LC100 (96 hours) (lowest loading at which 100% mortality was observed) = No mortality was observed. This value indicates that the substance 1-methylpiperidin-4-ol can be considered as not classified under short term toxicity to fish category.

In Supporting study, the 96 hrs aquatic toxicity study was predicted to assess toxic effects of the test compound 1-methylpiperidin-4-ol (CAS no. 106-52-5) and the result were predicted (SSS QSAR Prediction model, 2016). The study was based on the effects of the test compound on Danio rerio fish in a static fresh water system. The predicted data suggests the lethal concentration (LC50) for the test compound was estimated to be 455.921020508 mg/l on the basis of mortality effect.

Whereas supporting model which is based on the QSAR prediction done using the EPI Suite ECOSAR version 1.10 (EPI Suite, 2016), the 96 hours LC50 was estimated to be 7885.35 mg/l on fish for substance 1-methylpiperidin-4-ol (CAS no. 106-52-5) with mortality effects.

Similarly 96 hrs LC50 value (Danish QSAR database, 2016) of test substance Methyl N-methylanthranilate onPimephales promelasfish was determined by three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database. Based on mortality effect of test organismPimephales promelas, the estimated 96 hrs LC50 value was evaluated to be 831.2391mg/l.

Above predicted lethal concentrations supported by experimental study for read across chemical 1-Methylpiperazine (Cas no. 109-01-3) which is indicates that in Preliminary assessment of acute fish toxicity of test substance 1-Methylpiperazine at test concentrations 0,683,1050,1620,2500 and 3850 mg/l was used with study condition 24.7 deg.C study temp., 39.8 mg/L CaCO3 hardness, 7.74 PH, 48.8 mg/L CaCO3 Alkalinity and 7.2 mg/L dissolved oxygen in static freshwater for 96 hrs. on fish species Pimephales promelas of 31 days age with 18.0 MM length and 0.081 G weight. During experiment the gas liquid chromatography was used for analytical detection. For data analysis the LC50 with corresponding 95% confidence intervals were calculated using the corrected average of analyzed tank concentration and the Trimmed Spearman-Karber Method used. On the basis of mortality effect the lethal concentration for test substance 1-Methylpiperazine was found to be 2300 mg/l. (Geiger,D.L.,et al; Centre for Lake Superior Environmental Studies, University of Wisconsin, Superior, WI:328 p;1986)

Another experimental data (SIDS INITIAL ASSESSMENT PROFILE, CoCAM2, Pg. no. 1-3, 17-19 April 2012) for read across N-Methyldiethanolamine (Cas no. 105-59-9) indicates the 96 h 50% lethal concentrations for fish species Leuciscus idus as LC50= 1466 mg/L (nominal; static).

Thus, based on above experimental and predicted value from SSS QSAR, ECOSAR and Danish QSAR, and read across values it can be concluded that the substance 1-methylpiperidin-4-ol (CAS 106-52-5) can be considered as non toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP criteria.