Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-373-1 | CAS number: 58-28-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Some small clinical studies suggest that desipramine and other tricyclic antidepressants may reduce libido and cause erectile and ejaculatory dysfunction in males. Other reports have also associated desipramine with testicular pain and swelling.
[REPROTOX® Database: Klasco RK: REPROTOX® Database. Truven Health Analytics, Greenwood Village, Colorado.]
Effects on developmental toxicity
Description of key information
Based on experimental animal studies and human experience with imipramine, desipramine is not expected to increase the risk of congenital malformations. Desipramine (Norpramin; Pertofrane) is an active metabolite of imipramine.
Neonatal complications have been reported in newborns who were exposed to desipramine in utero. The symptoms observed during the first neonatal month have included colic, cyanosis, rapid breathing, and irritability. The pediatrician can be advised in advance that the mother has been taking this drug. Also, nortriptyline, a congener of desipramine, was associated with urinary retention in one newborn.
[REPROTOX® Database: Klasco RK: REPROTOX® Database. Truven Health Analytics, Greenwood Village, Colorado.]
Toxicity to reproduction: other studies
Description of key information
Desipramine enters human milk. Maternal and infant serum levels of desipramine and its metabolite 2-hydroxydesipramine were measured in an exclusively breastfed infant after one week of maternal treatment with high-dose desipramine (300 mg/d). Neither desipramine nor its metabolite were detected using cutoffs of 1 ng/mL and 5 ng/mL respectively. No signs of infant toxicity were observed during 3 weeks of maternal treatment.
Desipramine concentrations were reported as undetectable (<25 ng/mL) in 3 infants exposed during pregnancy and lactation to maternal doses of 150-200 mg/d, measured at 2.3-14.9 weeks of age.
An exclusively breastfed infant was exposed beginning at 16 weeks postpartum, for a total of 8 weeks, to maternal treatment with desipramine 100 mg/d. Development was normal at 3 years of age. The clinical significance of low levels of desipramine in the breastfed newborn is not well defined, so observation for possible behavioral effects has been recommended. The American Academy of Pediatrics categorized the effects of desipramine on the nursing infant to be "unknown but a possible cause for concern". In contrast, however, the WHO Working Group on Human Lactation assessed the use of desipramine during lactation as "probably safe," although they noted the need for more data to delineate the range of drug concentrations that may be found in milk.
[REPROTOX® Database: Klasco RK: REPROTOX® Database. Truven Health Analytics, Greenwood Village, Colorado.]
Justification for classification or non-classification
Overall, available data are inconclusive for the classification of the substance.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.