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Diss Factsheets
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EC number: 604-012-2 | CAS number: 137296-15-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Toxicological Profile for Ammonia
- Author:
- ATSDR, Agency for Toxic Substances and Disease Registry
- Year:
- 2 004
- Bibliographic source:
- U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Reference Type:
- publication
- Title:
- Prenatal Exposure of Rats to Ammonia Impairs NMDA Receptor Function and Affords Delayed Protection Against Ammonia Toxicity and Glutamate Neurotoxicity
- Author:
- Minana M.D., Marcaida G., Grisolia S. and Felipo V.
- Year:
- 1 995
- Bibliographic source:
- Journal of Neuropathology and Experimental Neurology, Vol. 54, No. 5, pp. 644-650
Materials and methods
Test material
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- from gestational day 1 through lactation day 21
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 other: % (w/w)
- Dose / conc.:
- 4 293 mg/kg bw/day
Examinations
- Fetal examinations:
- body weight, aspartate aminotransferase activity, NMDA receptor function
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Rats exposed to ammonium in utero and during lactation, which then received a normal diet, had a statistically significant reduction in body weight gain by 25 and 16% in male and female offspring, respectively, at 120 days of age.
Rats that were continued on the same ammonia diet as their dams had an even greater decrease in body weight
gain (27 and 26% for males and females, respectively) at 120 days of age. - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased NMDA receptor function in neurons. Binding of [H3]MK-801 (an NMDA receptor antagonist) to NMDA receptors was reduced by approximately 60% in cerebellar cell cultures from 8-day-old rats exposed to
ammonium in utero and during lactation (dams received 4,293 mg ammonium/kg/day in the diet from gestational day 1 through lactation day 8).
Additionally, aspartate aminotransferase induction was absent in treated neurons (occurred in neurons from control rats), which also indicates impairment of NMDA receptors. Treated neurons were much more resistant to the toxic effects of glutamate than control neurons; since glutamate toxicity is mediated by NMDA receptors, attenuation of glutamate toxicity is indicative of impaired NMDA receptor function.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 4 293 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- fetal/pup body weight changes
- Remarks on result:
- other: secondary to maternal toxicity
Applicant's summary and conclusion
- Conclusions:
- In conclusion, in a developmental toxicity, female Wistar rats were exposed to ammonium via the diet at concentrations of 20% (w/w) (corresponding to 4293 mg/kg bw/day) from gestational day 1 through lactation day 21. A reduction in body weight gain by 25 and 16% in male and female offspring, respectively, was observed at 120 days of age. Since only one concentration was tested, the LOAEL was considered to be 20% (w/w) ammonium (corresponding to 4293 mg/kg bw/day).
- Executive summary:
In a developmental toxicity study, ammonium was administered to Wistar rats in the diet at dose levels of 20% (w/w) (corresponding to 4293 mg/kg bw/day) from gestational day 1 through lactation day 21.
No information was available concerning maternal effects. Therefore, a maternal NOAEL/LOAEL could not be derived.
Rats exposed to ammonium in utero and during lactation, which then received a normal diet, had a statistically significant reduction in body weight gain by 25 and 16% in male and female offspring, respectively, at 120 days of age. Rats that were continued on the same ammonia diet as their dams had an even greater decrease in body weight gain (27 and 26% for males and females, respectively) at 120 days of age. In addition, decreased NMDA receptor function in neurons was observed in cerebellar cell cultures from 8-day old rats exposed to ammonium in utero and during lactation. Furthermore, aspartate aminotransferase induction was absent in treated neurons, which also indicates impairment of NMDA receptors.
Since only one concentration was tested, the developmental LOAEL is 20% (w/w) in the diet, corresponding to 4293 mg/kg bw/day. In addition, in the statement of EFSA on " Health risk of ammonium released from water fillers [EFSA Journal 2012, 10(10): 2918] it was stated: "Following this treatment, the offspring showed a significant decrease in body weight at 120 days of age. ATSDR (2004) concluded that the effects observed in the offspring were secondary to maternal toxicity."
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