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Diss Factsheets
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EC number: 215-713-4 | CAS number: 1345-04-6
- 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
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Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2004-2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- information on human exposure during pregnancy - sodium stibogluconaate
Data source
Reference
- Reference Type:
- publication
- Title:
- A comparison of liposomal amphotericin B with sodium stibogluconate for the treatment of visceral leishmaniasis in pregnancy in Sudan
- Author:
- Marius Mueller, Manica Balasegaram, Youssif Koummuki1, Koert Ritmeijer, Muriel Ramirez Santana and Robert Davidson
- Year:
- 2 006
- Bibliographic source:
- Journal of Antimicrobial Chemotherapy (2006) 58, 811–815
Materials and methods
- Study type:
- medical monitoring
- Principles of method if other than guideline:
- retrospective analysis of pregnant Visceral leishmaniasis patients treated with different regimen of Sodium stibogluconate
- GLP compliance:
- no
Test material
- Specific details on test material used for the study:
- sodium stibogluconate 20mg/kg im for 30 days
Method
- Type of population:
- general
- Ethical approval:
- not applicable
- Details on study design:
- retrospective analysis of 39 pregnant VL patients were from Gedaref or neighbouring Sennar states.
Thirteen (33%) women were in the first trimester, 16 (41%) in the second and 10 (26%) in the last.
Three groups: 1/ sodium stibogluconate (20 mg/kg intramuscularly once daily for 30 days); 2. four doses of AmBisome 3–7 mg/kg daily on days 1, 6, 11 and 16, followed by 20 mg/kg sodium stibogluconate intramuscularly once daily for 30 days; 3 AmBisome 3–7 mg/kg on days 1, 2, 3, 5, 10 and 15.
Results and discussion
- Results:
- sodium stibogluconate ( n=23), spontaneous aborted during treatment (n=13- 57%) , all in first or second trimester, none in third trimester. between day 13 and 30 of treatment. p <0,002.
combination (n=4) ; no spontanoud abortion
AmBisone (n=12): no spontanous abortion
Applicant's summary and conclusion
- Conclusions:
- Pentavalent antimony ( sodium stibogluconate ) - 20mg/kg /day can induce abortion during first and second trimester in pregnant women.
- Executive summary:
Objectives: Little is known about the treatment of visceral leishmaniasis (VL) in pregnancy, especially in resource-poor settings. We present a series of pregnant women with VL treated with either sodium stibogluconate or liposomal amphotericin B (AmBisome), or both, in eastern Sudan over 16 months.
Methods: We did a retrospective analysis of all pregnant VL patients treated in the Me ́decins sans Frontie`res (MSF) Um el Kher centre between January 2004 and April 2005. We diagnosed VL with laboratory confirmation of clinical suspects, and recorded the outcomes of treatment for pregnant women and their foetuses. We carried out a manual search of relevant publications and a systematic search of the literature in the MEDLINE database.
Results: We treated 23 women with sodium stibogluconate, 4 with AmBisome and sodium stibogluconate and 12 with AmBisome alone. There were 13 (57%) spontaneous abortions in the sodium stibogluconate monotherapy group, and none in either of the other two groups. All spontaneous abortions occurred in the first two trimesters. All patients, except one in the sodium stibogluconate group who defaulted, were discharged as cured in good clinical condition.
Conclusions: AmBisome treatment for VL appears to be safe and effective for pregnant women and their foetuses. We recommend the use of AmBisome as first-line treatment for these patients.
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.
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