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EC number: 242-809-3 | CAS number: 19090-60-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Adipic acid, ammonium salt
- EC Number:
- 242-809-3
- EC Name:
- Adipic acid, ammonium salt
- Cas Number:
- 19090-60-9
- Molecular formula:
- C6H10O4.xH3N
- IUPAC Name:
- ammonium 5-carboxypentanoate
- Test material form:
- solid: crystalline
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Han:WIST rats
Source: TOXI COOP ZRT.
Cserkesz u. 90.
1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rats as a rodent is one of the standard species
of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8-9 weeks old in first, second, third and
fourth step
Body weight range
at starting (first step): 140 - 144 g
Body weight range
at starting (second step): 137 - 144 g
Body weight range
at starting (third step): 149 - 152 g
Body weight range
at starting (fourth step): 133 - 143 g
Acclimatization time: 5 days in first step, 6 days in second step, 7 days in third
step and 8 days in fourth step
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua purificata
- Doses:
- 300 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- The acute toxic class method was carried out involving a stepwise procedure with the use of
300 mg/kg bw as the starting dose in three female rats. No animal died in first step, so further
three female rats were treated with the same (300 mg/kg bw) dose. No animal died in second
step, so further three female rats were treated with the 2000 mg/kg bw dose. No animal died in
third step, so further three female rats were treated with the same (2000 mg/kg bw) dose. No
animal died in fourth step, too. Test was finished, because the stopping criteria of Annex 2c of
OECD Guideline No. 423 (presented in Appendix VII) was met. - Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred at 300 mg/kg bw single oral dose of Ammonium Adipate. All female rats
in step 1 and step 2 survived until the end of the 14-day observation period.
No death occurred at 2000 mg/kg bw single oral dose of test item. All female rats in step 3
and step 4 survived until the end of the 14-day observation period - Clinical signs:
- other: In group 1 treated with 300 mg/kg bw dose no treatment related symptoms were observed throughout the 14-day post-treatment period. In group 2 treated with 300 mg/kg bw dose no treatment related symptoms were observed throughout the 14-day post-treatment p
- Gross pathology:
- All animals treated with 300 mg/kg bw dose survived until the scheduled necropsy on
Day 15 and all animals treated with 2000 mg/kg bw dose survived until the scheduled
necropsy on Day 15.
Slight hydrometra was detected in animal No.: 3039 of group 1 (300 mg/kg bw) and in
animal No.: 3041 of group 2 (300 mg/kg bw). Severe hydrometra was found in two animals
(No.: 3048, 3049) of group 4 (2000 mg/kg bw) Hydrometra is a physiological finding and
related to the estrous cycle of the animal.
No pathological changes were found related to the effect of the test item during the
macroscopic examination of animals treated with 300 or 2000 mg/kg bw dose. - Other findings:
- No death occurred after the single 2000 or 300 mg/kg bw oral dose of Ammonium Adipate.
There were no toxic clinical signs and any related to the effect of the test item found in body
weights and body weight gains during the study in both doses.
Autopsy revealed no treatment related pathological changes in both doses.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 is above 5000 mg/kg bw. It is not classifed as Acute toxicity (oral).
- Executive summary:
LD50 is above 5000 mg/kg bw.
No death occurred after the single 2000 or 300 mg/kg bw oral dose of Ammonium Adipate.
There were no toxic clinical signs and any related to the effect of the test item found in body weights and body weight gains during the study in both doses.
Autopsy revealed no treatment related pathological changes in both doses.
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