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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
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 source and target substances have similar (eco)toxicological properties because
• they share structural similarities with common functional groups: One quaternised ethanolamine moiety, one to three, mainly two ester groups with a typical UVCB distribution with long-chain fatty acids of natural origin. The molecular structure is almost identical.
• they are manufactured from similar resp. identical precursors (triethanolamine, long-chain fatty acids, dimethyl sulphate) under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident
• A constant pattern in the changing of the potency of the properties across the TEA-Esterquats by chain-length and the grade of esterification is not observed, because the fatty acid chain-length distribution is too narrow and similar and the distribution of mono-, di-, and tri-esters is identical. Some variation caused by variation in C=C double bonds may occur and will be discussed at the relevant endpoint.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See justification for read-across attached to chapter 13 of this IUCLID file.

3. ANALOGUE APPROACH JUSTIFICATION
See justification for read-across attached to chapter 13 of this IUCLID file.

4. DATA MATRIX
See justification for read-across attached to chapter 13 of this IUCLID file.
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
34 d
Key result
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
0.224 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
other: post hatch survival and overall survival
Duration:
30 d
Dose descriptor:
EC10
Effect conc.:
0.582 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks:
weight
Remarks on result:
other: 95% c.i. 0.287 – 1.18 mg/L
Duration:
30 d
Dose descriptor:
EC10
Effect conc.:
0.66 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks:
length
Remarks on result:
other: 95% c.i. 0.411 – 1.06 mg/L
Duration:
30 d
Dose descriptor:
EC10
Effect conc.:
95.041 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
other: Hatching success after 6 days
Remarks on result:
other: 95% c.i. 0.581 - > 4.68 mg/L
Duration:
30 d
Dose descriptor:
NOEC
Effect conc.:
0.461 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
other: fry growth (expressed as length and fresh weight)
Duration:
6 d
Dose descriptor:
NOEC
Effect conc.:
0.461 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
other: hatching success after 6 d
Conclusions:
Partially unsaturated TEA-Esterquat caused significant effects on Zebrafish in an early life stage test, 30 days post hatch when tested with nominal loading rates of 0.412, 0.824, 1.65, 3.30 and 6.59 mg test item/L, corresponding to the time weighted arithmetic mean measured (TWA) concentrations of 0.224, 0.461, 0.982, 2.60 and 4.68 mg test item/L.
For the parameter hatch, the NOEL was 0.824 mg test item/L nominal (TWA: 0.461 mg test item/L). Therefore, the respective LOEL was determined to be 1.65 mg test item/L nominal (TWA: 0.982 mg test item/L).
For the parameters post hatch survival and overall survival, the NOELs were 0.412 mg test item/L nominal (TWA: 0.224 mg test item/L), respectively. Therefore, the respective LOELs were determined to be 0.824 mg test item/L nominal (TWA: 0.461 mg test item/L).
For the parameter fry growth (expressed as length and fresh weight) the NOELs were 0.824 mg test item/L nominal (TWA: 0.461 mg test item/L) for both parameters. Therefore, the LOELs for length and weight were determined to be 1.65 mg test item/L nominal (TWA: 0.982 mg test item/L), respectively.
Based on read across, these results apply also to the target substance oleic acid-based TEA-Esterquat.

Description of key information

NOEC (Post-hatch survival, overall survival) = 0.224 (OECD TG 210, Danio rerio); GLP; RL1 (weighted arithmetic mean measured concentrations)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
NOEC
Effect concentration:
0.224 mg/L

Additional information

No experimental data are available for the target substance oleic acid-based TEA-Esterquat. However, a FELS test is available for the structurally related source substance partially unsaturated TEA-Esterquat. A justification for read-across is attached to Iuclid section 13.


 


The effects of the test item partially unsatd TEA-Esterquat on the early-life stage of fish (Danio rerio/ Zebrafish) were determined according to OECD Guideline 210.


 


A test item dispersion with a dry content of 10.3% was prepared from the original test item. Stock dispersions in demineralized water with nominal concentrations of 8.00, 16.0, 32.0, 64.0 and 128 g dispersion/L, corresponding to 0.824, 1.65, 3.30, 6.59 and 13.2 g test item/L were prepared in appropriate intervals of 3 to 4 days and continuously dosed to the dilution water in a flow-through system. Based on the results of a range finding test the test was conducted as a dose-response test with the nominal test item loading rates of 4.00, 8.00, 16.0, 32.0 and 64.0 mg dispersion/L, corresponding to 0.412, 0.824, 1.65, 3.30 and 6.59 mg test item/L ), corresponding to time weighted arithmetic mean measured concentrations of 0.224, 0.461, 0.982, 2.60 and 4.68 mg test item/L..


The test was started by placing fertilized eggs into the test vessels and it lasted 34 days (30 days post-hatch). 80 eggs of Danio rerio/ zebrafish were exposed to each test item loading rate and the control (4 replicates with 20 eggs each).


The water quality parameters pH-value, oxygen concentration, temperature and total hardness were within the acceptable limits.


On study day 4, 95% of the control larvae had hatched. Therefore, study day 4 was defined as post hatch day 0 (= PHD 0).


Different toxicological endpoints were determined: hatching success, fry growth (assessed via length and fresh weight measurements on PHD 30), morphological and behavioral effects, post-hatch survival and overall survival.


Specific analysis of various concentrations ofthe test item in the test media and the controls was carried out via LC-MS/MS.


The test media were sampled and analyzed from alternating test vessels prior to exposure on day -1 and during the exposure on study days 0, 7, 14, 21 and 28.


The measured concentrations of the test media during equilibration days -3 to -1 ranged between 70 and 109% of the nominal loading rates. The measured concentrations of the test media on study days 0 to 28 were in the range of 31 to 88% of the nominal loading rates.


The stock dispersions were sampled and analyzed from freshly prepared and corresponding 4 days aged stock dispersions. Measured concentrations of the freshly prepared stock dispersions were 92 to 99% of the nominal values. Measured concentrations of the 4 days aged stock dispersions in the range of 91 to 99% of the nominal values.


 


At the end of the exposure on study day 34 the aqueous phase of replicates used for analysis of glassware adsorption were analysed too. The sorption of the test item on glass was quantified at the loading rates of 4.00 and 16.0 mg dispersion/L from one replicate per test group at the end of the exposure and from one replicate the loading rate of 64 mg dispersion/L after 100 % mortality occurred.


 


Findings and Observations


The results of the parameters hatching success, fry growth (expressed as weight and length measurement at PHD 30), post-hatch survival and overall survival were checked for statistically significant differences.


The test item caused significant effects on Zebrafish in an early life stage test, 30 days post hatch when tested with nominal loading rates of 0.412, 0.824, 1.65, 3.30 and 6.59 mg test item/L, corresponding to the time weighted arithmetic mean measured (TWA) concentrations of 0.224, 0.461, 0.982, 2.60 and 4.68 mg test item/L.


For the parameter hatch, the NOEL was 0.824 mg test item/L (TWA: 0.461 mg test item/L). Therefore, the respective LOEL was determined to be 1.65 mg test item/L (TWA: 0.982 mg test item/L).


For the parameters post hatch survival and overall survival, the NOELs were 0.412 mg test item/L (TWA: 0.224 mg test item/L), respectively. Therefore, the respective LOELs were determined to be 0.824 mg test item/L (TWA: 0.461 mg test item/L).


For the parameter fry growth (expressed as length and fresh weight) the NOELs were 0.824 mg test item/L (TWA: 0.461 mg test item/L) for both parameters. Therefore, the LOELs for length and weight were determined to be 1.65 mg test item/L (TWA: 0.982 mg test item/L), respectively.