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EC number: 283-563-7 | CAS number: 84682-03-1
- 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
No toxicity data on adverse effects on sexual function and fertility with zinc bis(3,5,5-trimethylhexanoate) are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties zinc and 3,5,5-trimethylhexanoic acid. According to the RAAF, neodecanoic acid will be considered in place of 3,5,5-trimethylhexanoic acid.
Zinc bis(3,5,5-trimethylhexanoate) is not expected to impair fertility, since the two moieties zinc and, 3,5,5-trimethylhexanoic acid, as represented by neodecanoic acid, have not shown adverse effects on fertility.No information on the developmental toxicity of the moiety3,5,5-trimethylhexanoic acid or its representativeneodecanoic acid are available, thus no final conclusion on classification and labelling can be made.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No toxicity data on adverse effects on sexual function and fertility with zinc bis(3,5,5-trimethylhexanoate) are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties zinc and 3,5,5-trimethylhexanoic acid, as represented by neodecanoic acid.
Zinc
The reproductive toxicity of zinc compounds has been investigated in one and two generation reproductive toxicity studies in which rats or mice were dosed by gavage or via the diet with soluble zinc compounds (i.e., zinc chloride, zinc sulphate) at exposure levels up to 14 mg Zn/kg bw/day (gavage) or 200 mg Zn/kg bw/day (diet) (Khan et al., 2001, 2003, 2007; Samanta et al, 1986). Further information on potential effects of zinc compounds on male or female reproductive organs could be retrieved from sub-chronic toxicity studies as conducted by Maita et al. (1981) and Edwards and Buckley (1995).
The available information suggests that high oral doses of zinc (i.e., exposure levels greater than 20 mg Zn/kg bw/day) may adversely affect spermatogenesis and result in impaired fertility indicated by decreased number of implantation sites and increased number of resorptions (US EPA, 2005). However, these effects were only observed in the presence of maternal toxicity as seen in the one or two generation studies conducted by Khan et al. (2001, 2003, 2007) or, in case of the study conducted by Kumar et al. (1976), when other study non-zinc relevant study specificities could have impacted the study outcome.
In a large number of controlled trials, dietary supplementation with zinc rate of 20 mg/day and 30 mg/day did not result in any adverse reproductive effects in healthy pregnant women as summarised in WHO (2001) and ATSDR (2005).
Neodecanoic acid
In a modified three-generation reproductive toxicity study, male and female Sprague-Dawley rats were administered neodecanoic acid at 0, 100, 500 and 1500 ppm (approximately 0, 5, 25 and 75 mg/kg-bw/day, respectively) in the diet. No adverse effects were observed on survival, appearance, behaviour, body-weight gain and food consumption in the parental, F1 or F2 generations. The reproductive performance of the parents was not affected. No treatment-related gross or microscopic pathological findings were observed at any of the dietary levels.
No classification for reproductive or developmental toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Zinc bis(3,5,5-trimethylhexanoate)
Since no reproductive toxicity study is available for zinc bis(3,5,5-trimethylhexanoate), information on the individual moieties zinc and3,5,5-trimethylhexanoic acid, as represented by neodecanoic acid,will be used for the hazard assessment of zinc bis(3,5,5-trimethylhexanoate).For the purpose of hazard assessment of zincbis(3,5,5-trimethylhexanoate), the point of departure for the most sensitive endpoint of each moiety will be used for the DNEL derivation. In case of 3,5,5-trimethylhexanoic acid, as represented by neodecanoic acid, in zincbis(3,5,5-trimethylhexanoate), the NOAEL of 75 mg/kg bw/day for the reproductive toxicity will be used. For zinc the NOAEL of 0.83 mg/kg bw/day (human data) will be used.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Due to an absence of adverse effects seen in the reproductive toxicity tests with zinc and neodecanoic acid, as representative of 3,5,5-trimethylhexanoic acid, a classification for reproductive toxicity in accordance with regulation (EC) 1272/2008 is not warranted.
No information on the developmental toxicity of the moiety neodecanoic acid is available, thus no final conclusion on classification and labelling can be made.
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.
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