Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Data on clomipramine

Value:              31.5 mg/L (Mass concentration)

Original value:  100 microM (Molar concentration)

Class:               Oligochaeta

Duration:          15 min

Effect:               Physiology

Effect %:           ca. 19

Endpoint:         LOEC

Family:              Lumbriculus (aquatic oligochaete worm)

Infrakingdom:    Protostomia

Measurment:     heart rate

Data on clomipramine hydrochloride (similar substance)

No experimental data for aquatic toxicity were found for clomipramine hydrochloride; therefore, modelled data were used to estimate the potential for aquatic toxicity. Table that contains the predicted ecotoxicity values that were considered reliable and were used in the QSAR weight of evidence approach for aquatic toxicity (Environment Canada 2007b) is provided in the full documentation.

A range of aquatic toxicity predictions were obtained from the various QSAR models considered. The results suggest that clomipramine will have moderate to high toxicity to aquatic species and that the ionized form (corresponding to a measured log Kow of 3.32), which is likely to predominate at environmental pH 6-9, will be less toxic than the neutral compound. The ionized form of clomipramine is predicted to cause acute effects to aquatic species at concentrations ranging from <1 mg/L to about 10 mg/L. Based on this model evidence, clomipramine hydrochloride has the potential to be acutely toxic to aquatic organisms at relatively low concentrations (acute LC/EC50 values < 1.0 mg/L).

Overall, the substance is classified as Aquatic Acute 1 H400.

Biodegradation

In the absence of measured environmental biodegradation data, such as ready biodegradation data, and in light of the unanimity of the model predictions particularly relating to ultimate degradation, clomipramine hydrochloride will be considered to meet the persistence criteria (i.e., half-life in water is 182 days).

While the neutral form of clomipramine is predicted to have high bioaccumulation potential, the ionized form most likely to predominate in the environment has a low potential to bioaccumulate.

The substance is classified as Aquatic Chronic 1 H410.

Additional information