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EC number: 231-203-4 | CAS number: 7446-26-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data regarding effects on reproducitve toxicity are available for dizinc pyrophosphate. Reliable data are available from zinc chloride (CAS 7646 -85 -7). The zinc ion is considered to be the toxicologically relevant element and thus a read across to zinc chloride is reliable.
Oral, rat:
LOAEL systemic toxicity (zinc chloride) = 7.5 mg/kg bw/day
NOAEL reproductive toxicity (zinc chloride) = 15 mg/kg bw/day
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Limit test:
- no
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 7.5 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Critical effects observed:
- not specified
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 7.5 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Critical effects observed:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- body weight and weight gain
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- body weight and weight gain
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- no
- Conclusions:
- Under the test conditions, adminsitration of the source substance zinc chloride to adult male and female rats throughout maturation, mating, gestation and early lactation resulted in significant systemic toxicity effects as reduced body weight on adults in all dose levels. Reproductive toxicity effects and effects on pups were only seen at the highest dose group (30 mg/kg bw/day). Therefore, a systemic NOAEL could not be determined and a systemic LOAEL of 7.5 mg/kg bw/day was set. For reproducitive toxicity a NOAEL of 15 mg/kg bw/day is concluded.
- Executive summary:
As explained in the analogue justification, zinc is considered to be the toxic element. Therefore, it is considered that the target and the source substances are unlikely to lead to differences in reproductive toxicity potential.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from reference substances. Read-across is based on the basic assumption that the ionic species of the target substance are the determining factors for biological activity. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity
Justification for read-across
There are no data available on reproductive toxicity of dizinc pyrophoshpate. In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 read-across from appropriate substances is conducted to fulfill the standard information requirements set out in Regulation (EC) No 1907/2006, Annex VII, 8.5.
According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.
Reliable data are available from zinc chloride (CAS 7646 -85 -7). The zinc ion is considered to be the toxicologically relevant element and thus a read across to zinc sulfate is reliable.
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Zinc is necessary for normal growth and development (e.g. gene expression, metabolism of vitamins including folate, retinol) and therefore it is not surprisingly that a zinc deficiency can cause foetal damage as reported in animals (Walsh et al., 1994; ATSDR, 1994). Both human and animal data show that zinc deficiency will also lead to delayed sexual maturation and to impairment of reproductive capacity (WHO, 1996).
A two-generation study similar to OECD 416 in rats with zinc chloride is availabe in order to evaluate the reproductive toxicity potential (Khan, 2007). Male and female rats were administered zinc chloride via gavage at the doses of 7.5, 15.0 and 30.0 mg/kg bw/day over two successive generations. Control group animals received deionised water. There were no significant changes observed in the clinical pathology parameters after zinc chloride exposure to two generations of rats. The results in this study suggest very mild effec of zinc exposure on the erythrocytes (decreased packed cell volume (PCV)) in both P0 and P1 male and female rats. The PCV change was not of sufficient magnitude in either sex to have adversely affected reproductive performance. In this study, there seemed to be a trend toward elevated values of amylase, alkaline phosphatase and glucose in mid/ and high-dose males of both generations. Amylase and glucose are both associated with the pancreas. Although not statistically significant, these parameters appeared to be elevated in the zinc chloride treated groups and were propably manifestations of very mild pancreatic effect. Alkaline phosphatase is a zinc-dependent enzyme and slight (not significant) elevation in the zinc chloride treated groups would be exptected. This elevation probably had no adverse effect. The total body weight gain in zinc chloride treated males of both generations showed a significant reduction compared to their controls. However, the total body weight gain of zinc chloride treated females of both generations did not show any significant difference compared to their controls. This lack of significant zinc chloride treatment effect on total body weight gain of females suggested that toxicity from the test substance was not at a high level. The post-partum dam weight of P0 and P1 rats in all dose groups were significantly different from their control groups. The absolute and relative kidney, liver, spleen, seminal vesicles weights of P0 males and kidney, liver, spleen, adrenal, testis, prostrate, and seminal vesicle weights of P1 males were significantly reduced after 15 and 30 mg/kg bw/day of zinc chloride exposure during pre-mating and mating periods. The absolute and relative spleen and uterus of P0 females were signficantly reduced after 15 and 30 mg/kg bw/day of zinc chloride exposure during pre-mating and mating, gestation and lactation periods. Histopathological evaluation of the tissues in rats in both generations revealed prostatic acinar atrophy and inflammation in the reproductive system and the hematopoietic-lymphoreticluar system (splenic lymphoid depletion and hemosiderosis and thymic atrophy) of 30 mg/kg bw/day zinc chloride treated groups. So effects in organ weights at the mid-dose level could not be attributed to histopathological or clinical pathology and thus are considered to be not adverse. Zinc chloride exposure caused significant reduction in fertility of both generations, F1 pups viability (days 0 and 4) and litter size (F2) in high-dose group rats. Body weight gain of F1 and F2 pups on day 21 in the high-dose group was significantly reduced when compared to the control groups.
Under the test conditions, adminsitration of zinc chloride to adult male and female rats throughout maturation, mating, gestation and early lactation resulted in significant systemic toxicity effects as reduced body weight on adults in all dose levels. Reproductive toxicity effects and effects on pups were only seen at the highest dose group (30 mg/kg bw/day). Therefore, a systemic NOAEL could not be determined and a systemic LOAEL of 7.5 mg/kg bw/day was set. For reproductive toxicity a NOAEL of 15 mg/kg bw/day is concluded. 15 mg zinc chloride/kg bw/day corresponds to 7.2 mg zinc/kg bw/day.
In the SIDS for zincs category which includes six zinc substances including zinc metal, zinc oxide, zinc distearate, zinc chloride, zinc sulphate and trizinc bis(orthophosphate) the following conclusion on reproductive toxicity is given: Available data in experimental animals on zinc excess indicate that adverse effects on fertility and fetal development may occur at dose levels (200 mg Zn2+/kg bw/day) at which other effects such as perturbation of parental and fetal copper homeostasis are evident. The only available data in humans indicate that additional zinc up to 0.3 mg Zn2+/kg bw/day during pregnancy did not result in adverse reproductive or developmental effects. In analogy with the findings in animals, where reproductive toxicity was observed at higher dose levels than those at which other effects were already present, it was considered unlikely that in humans reproductive effects will occur at exposure levels at which clinical signs are not manifest.
This conclusion is in line with the findings observed in the 2 -generation study with zinc chloride. Thus, as dizinc pyrophosphate would also fit in this category no reproductive toxicity potential is assumed for dizinc pyrophoshpate as well.
References:
ATSDR (1994). Toxicological profile for zinc (update). Agency for Toxic Substances and Disease Registry, Atlanta.
SIDS initial assessment profile, (2005);http://webnet.oecd.org/Hpv/UI/handler.axd?id=fddec5fa-9727-413a-9d67-41c2154cd362
Walsh CT, Sandstead HH, Prasad AS, Newberne PM and Fraker PJ (1994). Zinc: Health effects and research priorities for the 1990s. Environ. Health Perspect 102, 5-46.
WHO (1996). Zinc. In: Trace Elements in Human Nutrition and Health. WHO, Geneva, Chapter 5.
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
Based on read-across, the available data on reproducitive toxicity indicate that dizinc pyrophosphate does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.
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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