Reaction mass of pentadecylamine and tridecylamine and 2-Methyldodecylamine and 2-Methyltetradecylamine

Short-term toxicity to fish

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:

19.05.1997 - 23.06.1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Cited as Directive 92/69/EEC, C.1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

Adopted: July 17, 1992

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 1 mg/l in first part of the study and 0, 0.22, 0.5, and 2.2 mg/L in the second part of the study based on the results of the range-finding tests.
- Preparation of test concentrations: The test substance was weighed into a beaker. To improve the dissolvation process the pH-value of the test water was adjusted with concentrated HCl to approx. pH 6 before insertion of the test substance. A mixture of the test substance and test water was homogenized using an Ultra-Turrax and introduced into the test chambers. The chamber contents were stirred for approximately 1 hour at pH 6 with a KPG-stirrer and a glass rod to ensure that the limit of solubility was reached. The pH was then adjusted to the pH of the test water with 10molar NaOH. In order to determine the substance concentration, water samples were taken from the middle of the test chamber by pipetting approx. 20 mL into a screw-neck glass bottle at study start, and after 48 and 96 hours.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: direct dissolution in test water, adjustment of pH to improve dissolution, homogenisation by using an Ultra-Turrax

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Brachnydanio rerio (Hamilton-Buchanan)
- Source: Charles River Aquatics, Broekman Institut, 5711 CP Someren, Netherlands
- Age at study initiation (mean and range, SD): approx. 14 w
- Length at study initiation: 1 part of study: 2.5 -2.8 cm, 2 part of study:2.6 - 2.9 cm (total sample: 2.5 - 2.9)cm
- Weight at study initiation (mean and range, SD): no data


ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Tetra Min, Tetra Werke, Melle (Germany)
- Feeding frequency: twice daily ad libitum
- Health during acclimation (any mortality observed): no data


FEEDING DURING TEST
- Food type: no feed for the entire study period

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

2.1 mmol Ca2+ + Mg 2+ / L

Test temperature:

22 +/- 1°C

pH:

The pH was measured before the use of each study batch. It was in a range of 7.9 - 8.1.

Dissolved oxygen:

The dilution water was prepared as described and aerated until oxygen saturation with an oxygen content of ≥ 80% of the saturation value.

Nominal and measured concentrations:

0, 0.22, 0.5, 1.0 and 2.2 mg/L (nominal)
Analysis: at 0.5, 1.0 and 2.2 mg/L. All measurements were -+10 % of the theoretical value.

Details on test conditions:

TEST SYSTEM
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: The test chambers, which were calibrated to 4 liters, were made of glass (length 20 cm, width 15 cm, height 20 cm) and stood in a water bath made of Hostalit Z® with a Plexiglas viewing panel.
- Aeration: The test chambers were not aerated during the course of the study, except in the case of the 1.0 mg/L group, which was aerated from 48 hours after study start on, because from then on the maintenance of an oxygen conten of at least 60% of the saturation value was not ensured. Aeration was carried out using a glass capillary with a bubble-frequency of 1-3 per second.
- No. of organisms per vessel: 7 fish in each test and control chamber
- Biomass loading rate: < 1g fish/ L water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water, composition according to ISO/DIS 7346-1 was used as water for dilution.
- Water Quality parameters temperature, pH, Oxygen content were observed throughout the investigation

OTHER TEST CONDITIONS
- Adjustment of pH: yes, due to TS at study start
- Photoperiod: The chambers were illuminated from above 6.00 a.m. to 6.00 p.m.
- Light intensity: The light intensity directly over the chambers was approximately 700 lux.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.5 - < 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 0.5 - < 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

MORTALITY (96 h)

0.22 mg/L 0/7
0.5 mg/L 0/7
1.0 mg/L 5/7
2.2 mg/L 7/7

CLINICAL SIGNS
noted in all groups: hyper- and hypoactivity, projecting operculae,swimming at bottom, decreased reflexes, twitching, irregular respiration.

Dead fish showed a metallic-like sheen and coloured integument.

Validity criteria fulfilled:

yes

Remarks:

Mortality 0 % in controls; test conditions fulfilled; test concentration > 80 % of nominal

Conclusions:

The LC50 of n/i-C13/C15-Amine after 96 hours was in a range of 0.5 - 1 mg/L under the conditions of this test.

Executive summary:

n/i-C13/C15 -Amine was tested in an acute toxicity test on zebra fish (Brachydanio rerio) according to OECD 203 and GLP over 96 hours in a static system.

The concentrations tested were 0.22, 0.5, 1.0, 2.2 mg/L and a negative control (0 mg/L). All tested concentrations were present as clear solutions. The substance concentration was determined in the 0.5, 1.0, 2.2 mg/L groups. All values determined were in a range of ± 10 %.

In this 96 -hour acute toxicity study of n/i-C13/C15 -Amine the following lethality values were determined:

	after 24 hours	after 48 hours	after 72 hours	after 96 hours
LC 0 (mg/L)	1.0	0.5	0.5	0.5
LC50 (mg/L)	1.48	0.5 - 1.0	0.5 - 1.0	0.5 - 1.0
LC100 (mg/L)	2.2	2.2	2.2	2.2

In the 2.2 mg/L group recording of symptoms was not possible because of 100 % lethality at the first inspection date. Symptoms and lethality were observed at 1.0 mg/L. The 0.22 and 0.5 mg/L group exhibited symptoms but no lethality. In the control group no lethality was observed.

Description of key information

The LC50 of n/i-C13/C15-Amine after 96 hours was in a range of 0.5 - 1 mg/L under the conditions of this test.

Additional information

n/i-C13/C15 -Amine was tested in an acute toxicity test on zebra fish (Brachydanio rerio) according to OECD 203 and GLP over 96 hours in a static system.

The concentrations tested were 0.22, 0.5, 1.0, 2.2 mg/L and a negative control (0 mg/L). All tested concentrations were present as clear solutions. The substance concentration was determined in the 0.5, 1.0, 2.2 mg/L groups. All values determined were in a range of ± 10 %.

In this 96 -hour acute toxicity study of n/i-C13/C15 -Amine the following lethality values were determined:

	after 24 hours	after 48 hours	after 72 hours	after 96 hours
LC 0 (mg/L)	1.0	0.5	0.5	0.5
LC50 (mg/L)	1.48	0.5 - 1.0	0.5 - 1.0	0.5 - 1.0
LC100 (mg/L)	2.2	2.2	2.2	2.2

In the 2.2 mg/L group recording of symptoms was not possible because of 100 % lethality at the first inspection date. Symptoms and lethality were observed at 1.0 mg/L. The 0.22 and 0.5 mg/L group exhibited symptoms but no lethality. In the control group no lethality was observed.