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EC number: 469-910-7 | CAS number: 847842-48-2
- 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
Description of key information
Additional information
Apart from the Key hydrolysis study (White & Mullee), all studies were carried out on one of the analogue materials. The analogues are considered to be sufficiently similar to the substance of interest (please see attached data matrix and justification in Section 13 for additional details) for them to be used for the purposes of health and environment risk assessments.
Hydrolysis:
(White & Mullee - 2007) The stusy concluded that the reference material (Abacavir Glutarate) had an estimated half-life at 25°C as follows:
pH 4: Approximately > 1 year
pH 7: > 1 year
pH 9: > 1 year
An additional hydrolysis study (Sydney - 1997) concluded that the analogue material (Abacavir Succinate) is hydrolytically stable under acidic, neutral and basic conditions.
Biodegradation:
Two studies have been carried out to assess the analogue materials Abacavir Succinate and Abacavir Hemisulphate for biodegradation in water:
Abacavir Succinate
Jenkins (1996):
Degradation of the test material was slow but progressive throughout the test; the mean cumulative CO2production was equivalent to 27% of the TCO2(range 25 to 29%) after 28 days.
The test material cannot therefore be considered to be ultimately degradable. The results of HPLC analysis at the end of the test suggests that the parent molecule may have been subject to primary degradation the extent of which ranged from 41% to 94%.
Abacavir Hemisulphate
Swarbrick & Smyth (2004): Analysis of the biotic exposure at the end of the 14 day test period showed mean degradation of equal to or >99%.
A study has been carried out to assess the analogue material Abacavir Succinate for biodegradation in soil:
Abacavir succinate did not readily undergo aerobic biodegradation in any of the soils examined with 15.3%, 16.8% and 11.4% of the applied test material recovered as carbon dioxide in the clay loam, sandy loam and sandy silt loam soils respectively. Adsorption/desorption: For the following reasons, no determination was possible by Method C19 of Commission Directive 2001/59/EC (which constitutes Annex V of Council Directive 67/548/EEC). The method guideline states that the measurement of adsorption coefficient should be carried out on substances in their ionised and unionised forms. The test material is a salt and is made up of two components, abacavir and glutaric acid. The abacavir component has predicted dissociation constants of 14.86, 6.53 and -3.38 using ACD/pKa 8.03. The glutaric acid component has an experimental database match for dissociation constants of 5.50 and 4.39 using ACD/pKa DB 8.02. Based on this information, this suggests that the abacavir component would be unionised between approximately 7.5 and 13.5. The glutaric acid component is unionised below approximately 3.5. As the pH of sewage treatment plants operate between pH 5.5 and 7.5 and the environmentally relevant range is between approximately 5.5 and 8.5, testing is usually conducted in the latter range. However, the test material is a salt containing amine groups. Experience has shown that positively charged nitrogens can interact with the column stationary phase by forces other than partitioning.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.

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