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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-996-5 | CAS number: 689294-28-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
/
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There are no experimental nor literature toxicological data available on TATD-CLE. Therefore the read across approach was considered in order to trace a complete toxicological profile of the substance.
RA: Cefuroxime (EC: 259-560-1; CAS: 55268-75-2)
Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 3200 mg/kg/day (14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the foetus due to cefuroxime axetil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Reference
NLM/FDA Drug Labelling. CEFTIN (cefuroxime axetil) powder, for suspension. Labeler - GlaxoSmithKline LLC (167380711). Rev. 2011.
Short description of key information:
No adverse effects on the fertility are expected.
Effects on developmental toxicity
Description of key information
No developmental toxicity is expected.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There are no experimental nor literature toxicological data available on TATD-CLE. Therefore the read across approach was considered in order to trace a complete toxicological profile of the substance.
RA: Cefalonium (EC: 226-948-7; CAS: 5575-21-3)
In an oral teratogenicity study in rats no teratogenic effects were observed at doses of 20, 200 and 2000 mg cefalonium/kg bw. The NOEL for embryotoxicity and teratogenicity therefore was 2000 mg/kg, the highest dose tested. Food and water intake were, respectively, statistically significantly lower and higher in both mid and high dose treated dams. Caecum weight was increased in drug treated dams at all dose levels[1].
RA: Cefuroxime (EC: 259-560-1; CAS: 55268-75-2)
Pregnancy Category B. Reproduction studies have been performed in mice at doses up to 3200 mg/kg/day (14 times the recommended maximum human dose based on mg/m2) and in rats at doses up to 1000 mg/kg/day (9 times the recommended maximum human dose based on mg/m2) and have revealed no evidence of impaired fertility or harm to the foetus due to cefuroxime axetil. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed[2].
A review containing results of teratogenicity tests of fifteen cephalospirins shoed little evidence for teratogenicity of members of this group in general. In addition, studies were provided on parenteral reproductive toxicity of cefuroximine and ceftazidime. In these studies no teratogenic effects were found and no evidence was found for general reproductive toxicity (fertility and peri and post natal development). The main effects found were changes of food and water intake of dams and increased caecum weight of dams and pups. Taking into consideration the provided information on the general absence of teratogenic effects and reproduction toxicity in cephalosporins, no further teratogenicity and reproduction data were considered necessary[1].
Reference
[1 ]EMEA, Committee for veterinary medicinal products. Cefalonium. Summary report. EMEA/MRL/646/99-Final.August 1999.
[2]NLM/FDA Drug Labelling. CEFTIN (cefuroxime axetil) powder, for suspension. Labeler - GlaxoSmithKline LLC (167380711). Rev. 2011.
Toxicity to reproduction: other studies
Additional information
/
Justification for classification or non-classification
According to CLP regulation (EC1272/2008), 3.7 reproductive toxicity section, reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. The definitions presented are adapted from those
agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals.
Reproductive toxicity of TADT-CLE has been evaluated on the basis of the read across with analogues. Studies on animals did not revealed any reasons of concern for fertility nor for the developmental toxicity. There are, however, no adequate and well-controlled studies in pregnant women.
In conclusion, according to CLP regulation (EC1272/2008), TADT-CLE is not classified for the reproductive toxicity.
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.