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Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

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 toxicological and ecotoxicological properties because they share structural similarities with common functional groups: quaternary amines, esters, and fatty acid chains varying in their length and degree of (un)saturation. Moreover, the fatty acid chains are chemically simple structures which have no structural alerts for toxicity, and which are closely related to substances of known low toxicity (i.e. stearic acid, oleic acid, linoleic acid, linolenic acid). Furthermore, the substances can be expected to have comparable breakdown products (MDEA or MDIPA and long chain fatty acids).

This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance MDEA-Esterquat C18 unsatd. are predicted to be similar to those of the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd.

Therefore, read-across from the available physicochemistry, toxicity and ecotoxicity studies with the source substances MDIPA Esterquat C18 unsatd., MDEA-Esterquat C16-18 and C18 unsatd. and MDIPA-Esterquat C16-18 and C18 unsatd. are considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance MDEA-Esterquat C18 unsatd., in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.


2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to read-across justification attached to Iuclid section 13

3. ANALOGUE APPROACH JUSTIFICATION
please refer to read-across justification attached to Iuclid section 13

4. DATA MATRIX
please refer to read-across justification attached to Iuclid section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Test organisms (species):

Daphnia magna

Water media type:

freshwater

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 8.6 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Conclusions:

Based on read-across from the source substances MDIPA Esterquat C18 unsatd. and MDEA-Esterquat C16-18 and C18 unsatd. The 48 h EC50 of the target substance MDEA-Esterquat C18 unsatd. in Daphnia magna is >8.6 mg/L.

Description of key information

Based on read-across from the source substances MDIPA Esterquat C18 unsatd. and MDEA-Esterquat C16-18 and C18 unsatd. The 48 h EC50 of the target substance MDEA-Esterquat C18 unsatd. in Daphnia magna is >8.6 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 8.6 mg/L

Additional information

No experimental data are available for the target substance MDEA-Esterquat C18 unsatd. However, short-term toxicity studies in Daphnia magna are available for the structurally related source substances MDEA-Esterquat C16-18 and C18 unsatd., MDIPA-Esterquat C16-18 and C18 unsatd., and MDIPA-Esterquat C18 unsatd. 

A justification for read-across is attached to Iuclid section 13.

 

The 24-hr acute toxicity of MDEA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was investigated under static conditions in a study conducted according to OECD TG 202 (Part I). Daphnids were exposed to 0, 0.1, 0.32, 1.0, 3.2, 10 and 32 mg/L (nominal) for 24 hours. Immobilisation was observed at test termination. The 24-h EC50 was 14.8 mg/L with 95% CL of 8.4 - 26.2 mg/L (nominal each). No other effects were noted. The study period of 24 h was recommended before adoption of the OECD Guideline 202 in 2004. Therefore, this study does not meet the time criterium (study duration 24 h instead of 48 h) of today standard methods.

 

The 48–hr-acute toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to control and test chemical at analytically confirmed nominal concentrations of 0, 2.5, 4.5, 8.1, 14 and 25 mg/L in the presence of 4 mg/L (< 2mg/L DOC) humic acid for 48 h.  Immobilisation was observed daily. 

The 48-hour EC50 was 6.7 mg/L (analytically confirmed nominal concentration) based on immobilisation.  

 

The 48–hr-acute toxicity of MDIPA Esterquat C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids were exposed to control and test chemical at nominal concentrations of 0.10, 0.32, 1.0, 3.2, 10 mg/L, corresponding to measured (TWA) concentrations of 0.077, 0.27, 0.89, 2.8 and 8.6 mg/L in the presence of 4 mg/L humic acid for 48 h.  Mortality/immobilisation and sublethal effects were observed daily. 

The 48-hour EC50 was >8.6 mg/L (TWA) based on immobilisation.  

 

Conclusion

Based on read-across from the source substances MDIPA Esterquat C18 unsatd. and MDEA-Esterquat C16-18 and C18 unsatd. The 48 h EC50 of the target substance MDEA-Esterquat C18 unsatd. in Daphnia magna is >8.6 mg/L.