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Diss Factsheets
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EC number: 231-212-3 | CAS number: 7447-41-8
- 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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1973
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data not sufficient for evaluation. Retrospective report used for read-across. Lithium substance not exactly specified.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Lithium and Pregnancy-I, Report from the Register of Lithium Babies
- Author:
- Schou, M. et al.
- Year:
- 1 973
- Bibliographic source:
- British Medical Journal, 1973, 2, 135-136
Materials and methods
- Study type:
- health record, other
- Remarks:
- Register of Lithium Babies
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline followed
Test material
- Reference substance name:
- Lithium compounds (not specified)
- IUPAC Name:
- Lithium compounds (not specified)
Constituent 1
Method
- Type of population:
- other: "lithium babies" born of a woman who had been treated with lithium during the first trimester of pregnancy
- Ethical approval:
- not specified
- Details on study design:
- The Register of Lithium Babies started on a Scandinavian basis, but soon reports also arrived from outside Scandinavia. During the past few years information has been collected in the United States and Canada.
The existence of the Register has been announced through notes published at intervals in psychiatric and general medical journals. These notes urged physicians to submit reports about lithium babies, normal or abnormal, that might come to their notice. A "lithium baby" was defined as a child born of a woman who had been treated with lithium during the first trimester of pregnancy. Congenital malformations were defined as macroscopic abnormalities of structure attributable to faulty development and present at birth.
Results and discussion
- Results:
- The study does not allow any conclusion if lithium could cause a high risk with regards to malformations in unborn.
Any other information on results incl. tables
Out of the 118 children reported five were stillborn and seven died within the first week of life; six of these 12 children were malformed. The total number of malformed children was nine. There were two children with Down`s syndrome. Most of the malformations were serious and led to death shortly after birth; the cardiovascular system was involved in six of the nine cases.
The information was collected retrospectively, and one must therefore expect an over-representation of abnormalities among the reports. A lithium baby is more likely to be recognized as such and reported to the Register if it is stillborn or malformed or dies soon after birth than if it is alive and normal in every respect. Little attention has been paid to drugs taken during the pregnancy by mothers of normal and healthy children, whereas the birth of an abnormal child almost certainly leads to inquiries on this point.
Applicant's summary and conclusion
- Conclusions:
- The authors themselves conclude that retrospective reporting is not a suitable method for detecting an increased risk for developmental defects in lithium-exposed mothers. The retrospective study design as well as the authors' intentions and conclusions disallow any inference into an increased teratogenic potential of lithium in humans.
- Executive summary:
In a retrospective study, babies of mothers treated with Lithium carbonate in the first trimester were analysed for the potential malformation to the unborn. The authors concluded that the study does not allow any conclusions if Lithium could cause a high risk with regards to malformations in the unborn.
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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