Amines, N-(C18-unsatd. alkyl)trimethylenedi-, ethoxylated

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

13 - 17 January 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed according to test guidelines and GLP, no chemical analyses, glassware presoaked!

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
The short term toxicity test result as observed for the tallow based product is read across to the Oleyl based product. The products differ only in their alkylchain distribution. Both tallow and Oleyl are natural fats for which the composition slightly changes over time due to changes in the environmental considitions.

The tallow alkyl fat which is used for the production of CAS no 1268344-02-0 are for 99 % straight chain alkyl fats

Commercial tallow alkyl fats have the following distribution:

C12 about 2 %
C14 about 4 %
C16 about 31 %
C18 about 65 %,
where 40 –50 % are unsaturated.

The oleyl fate which is used for the production of CAS no 1290049-56-7 are also straight chain fates

Commercial Oleylfats have the following distribution:

C12 1 %
C14 2 - 4 %
C16 and C16’ 12 - 14 %
C18, C18’ and C18’’ > 80 % (C18: 8 %, C18’cis: 46 %, C18’trans: 21 %, C18’’: 5 %)
C20 1 %
(a single prime indicates one double bond, a double prime indicates two double bonds):

When the water solubility of cationic surfactants based on tallow are compared to oleyl based cationic surfactants it is consistently the tallow product which has a sligthly lower water solubility and due to that also a slightly lower bioavailability. This lower bioavailability regularly results is slight differences in biodegradation rate and ecotoxicity. The substances are however difficult to test substances and the variation in the test results is especially in ecotoxicity testing frequently larger than the difference in bioavailability. It is therefore considered justified to use the tallow product test results for read across for the oleyl based product.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

Semi-static

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Details on test solutions:

Test concentrations: 0.1, 0.18, 0.32, 0.56 and 1.0 mg/L with a daily renewal.
Test concentrations were set following a preliminary rangefinding study. Two fish were exposed for a period of 96 hours under static test conditions at concentrations of 0.1, 1.0 10 and 100 mg/L. The resulst showed no mortalities or other adverse reactions to exposure at 0.1 mg/L and 100% mortalities at 1, 10 and 100 mg/L after 24 hours.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Source: Parkwood Trout farm, Wigmore Kent Uk
Stock hald since 17 October 1991 and acclimatised to test conditions from 6 to 13 January 1992
The stock fish were maintained in a glass fibre tank iwht a single pass water renewal system. The lighting was controlled to give a 16 hours light and 8 hous darkness cycle.
The holding temperature was 14°C
Dissolved oxygen ≥ 10 mg/L
Feeding: Commercial trout pellets daily, discontinued 24 h prior to the test.
Mortalities: Zero in the 7 days prior to the start of the test.
Medication: none
Mean standard length: 5.3 cm (SD = 0.4 cm)
Mean weight : 1.81 g (SD = 0.19)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Total hardness approximately 50 mg/L as CaCO3

Test temperature:

14 °C

pH:

Range: 7.4 - 7.5 for all test concentrations

Dissolved oxygen:

Range: 10.0 - 10.3 mg/L for all test concentrations

Salinity:

Test water = laboratory tap water dechlorinated by the additon of sodiumthiosulphate.

Nominal and measured concentrations:

Control, 0.1, 0.18, 0.32, 0.56 and 1.0 mg/L nominal

Details on test conditions:

Test vessels: Glass Aquario holding 20 L of test media\
10 animals per test test concentration
Loading 0.91 g bodyweight/litre
Aeration via narrow bore glass tubes.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.13 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

100 purity

Basis for effect:

other: absense of respiratory movement and response to physical stimulation

Remarks on result:

other: 95% CL 0.1 - 0.18 mg/L

Details on results:

Highest test concentration resulting in 0% mortality = 0.1 mg/L
lowest test concentration resulting in 100% mortality = 0.18 mg/L
No observed effect concentration = 0.1 mg/L which is based on no mortalities and the absence of any behavioural reactions to exposure at this concentration.

Reported statistics and error estimates:

Analyses of mortality is performed according the method of Thompson (1947)

Sublethal observations / clinical signs:

Cumulative mortality data for Rainbow trout exposured during 96 hours to Tris(2-hydroxyethyl) n-tallow alkyl diamino propane  Concentration (mg/L) 3   6  24  48  72  96 Control  0   0  0  0  0  0  0.1  0  0  0  0  0  0  0.18  0  0  0  4  10  10  0.32  0  0  10  10  10  10 0.56   0  8  10  10  10  10  1.0  9  10  10  10  10  10

Validity criteria fulfilled:

no

Remarks:

No chemical analyses

Conclusions:

Valid with restrictions. No chemical analyses, results are based on nominal concentrations. Glassware was presoaked with test solutions and refreshed on a daily bases to ensure close to nominal exposure concentrations.

Executive summary:

The acute toxicity of Tris(2-hydroxyethyl) n-tallow alkyl diamino propane (CAS no 90367-27-4) to fresh water fish Oncorhynchus mykiss (rainbow trout) was tested under semi-static conditions for 96 hours in accordance with OECD guideline 203 for testing chemicals. The test was performed in compliance with Good Laboratory Practice (GLP).

The 96 h LC50 was calculated to be 0.13 mg/l (95% c.l. 0.1 - 0.18). Based on the test results a NOEC (no observed effect concentration) after 96 hours was observed at 0.10 mg/L. No sub-lethal effects were observed at concentrations where no mortality was observed after 96 hours of testing.

No chemical analyses was performed but presoaking of the glassware and daily refreshment of the test solutions were considered to be sufficient to ensure stable exposure concentrations.

Description of key information

Results from two short term studies (96-h) with fish are available. One test was performed with a substance of the same category with a similar carbon chain distribution. No difference in toxicity is expected to occur in a short term toxicity test. A supportive study performed with the actual substance is available but due to that key information regarding substance identity is missing in the report it is considered not reliable. However, both studies have a result in the same range, 0.13 mg/L and 0.17 mg/L. Further information on the justification for read across is to be found in IUCLID chapter 13.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.13 mg/L

Additional information

Most of the short-term toxicity fish tests were conducted in a period when no reliable specific method of analyses was available. The concentrations were therefore not analytically verified, the reliability of the results is therefore considered limited. The available data, on short term toxicity to fish, reveal a comparable toxicity between tallow and oleyl based diamine ethoxylates.