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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-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 properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: quaternary ammonium and saturated or unsaturated alkyl chains with comparable length (corresponding to scenario 2 of the read-across assessment framework)

The read-across hypothesis is based on structural similarity of target and source substances. Based on available experimental data, including key physicochemical properties and data from acute toxicity, irritation, sensitization (human) and genotoxicity studies, the read-across strategy is supported by a quite similar toxicological profile of all substances.

Therefore, read-across from the existing ecotoxicity, environmental fate and toxicity studies conducted with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

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

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

3. ANALOGUE APPROACH JUSTIFICATION
See justification for read-across attached to IUCLID section 13.

4. DATA MATRIX
See justification for read-across attached to IUCLID section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Test organisms (species):
Daphnia magna
Water media type:
freshwater
Total exposure duration:
21 d
Duration:
21 d
Dose descriptor:
NOEC
Remarks:
Water from White river: pH 8.4-8.6, 345-363 mg/L CaCO3, 3-5 mg/L susp. matter
Effect conc.:
0.19 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
other: reproduction and mean length
Remarks on result:
other: extrapolated based on differences in QSAR estimation
Conclusions:
In a 21d Daphnia reproduction study in river water the NOEC was 0.19 mg/L (reproduction).

Description of key information

NOEC = 0.19 mg/L (read-across from DODMAC)

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.19 mg/L

Additional information

No experimental data are available for the target substance Di-C12-18 alkyldimethyl ammonium chloride. However, long-term toxicity studies inaquatic invertebratesare available for the closely related source substanceDODMAC. A justification for read-across is attached to IUCLID section 13.

 

The no observed effect concentration (NOEC) for daphnids exposed to 14C-labelled DODMAC in river water was 0.38 mg/L. Length, total young and mean brood size of adults exposed to mean concentrations of >= 0.76 mg/L DODMAC were significantly less (p<= 0.05) than the same parameters for adults in the controls and in the remaining test waters. For example, total young produced at the 0.76 mg/L concentration was approximately 38% less than that for adults exposed to 0.38 mg/L. Mean brood sizes reflected these differences in young production, generally declining at concentrations > 0.38 mg/L.

 

From the QSAR data on short-term toxicity it was deduced, that the target substance should be expected to be more toxic than the source substance DODMAC, and a factor of approx. 2 should be applied to the NOEC obtained in this study. Thus, the NOEC of the target substance Di-C12-18 alkyldimethyl ammonium chloride is considered to be 0.19 mg/L.