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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 22 July 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Husbandry
Animal health: Only healthy animals (and not showing any sign of skin
lesion) were used
Housing during
acclimatization period: Grouped caging in small groups
Housing during the test: Grouped caging (4 animals/cage)
Cage type: Type II. Polypropylene / polycarbonate
Bedding: Laboratory bedding
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 – 70 %
Housing/Enrichment: Mice were group-housed to allow social interaction, and with
deep wood sawdust bedding, to allow digging and other
normal rodent activities.
The same conditions were used for the dose range finding and main test animals. There were
no deviations from these specifications during the experimental phase. The temperature and
relative humidity were recorded daily during the acclimatization and experimental phases.
Before housing the animals, the microbiological status of the room was checked.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol -water (7:3) (EtOH) , acetone, olive oil,
- Concentration:
- 5, 2.5, 1, 0.5 w/w% (EtOH)
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.7
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Test group / Remarks:
- 2.5 %
- Key result
- Parameter:
- SI
- Value:
- ca. 1.6
- Test group / Remarks:
- 1%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.6
- Test group / Remarks:
- 0.5%
- Cellular proliferation data / Observations:
- No significant lymphoproliferative response (SI ≥ 3) compared to the relevant control (EtOH) was noted for Ammonium Adipate at the tested concentrations.
Any other information on results incl. tables
Table 4:Individual Body Weights of the Animals with Group Means
and the Body Weight Changes in the Dose
Range Finding Test
Animal | Dose Group | Initial Body | Terminal Body | Body Weight |
Number | Weight (g) | Weight (g)* | Change (%) | |
281 | Ammonium Adipate | 20.8 | 20.0 | -4 |
334 | 5 % in EtOH | 18.7 | 18.3 | -2 |
Mean | 19.8 | 19.2 | -3 | |
309 | Ammonium Adipate | 20.7 | 19.8 | -4 |
335 | 2.5 % in EtOH | 18.2 | 17.9 | -2 |
Mean | 19.5 | 18.9 | -3 | |
282 | Ammonium Adipate | 20.8 | 20.9 | 0 |
336 | 1 % in EtOH | 18.4 | 18.2 | -1 |
Mean | 19.6 | 19.6 | 0 |
*Terminal body weights
were measured on Day 6.
EtOH = Absolute ethanol:water 7:3 (v/v) mixture
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present assay, Ammonium Adipate tested at the maximum
attainable concentration of 5 % (w/v, based on solubility) and at concentrations of
2.5 %, 1 % and 0.5 % (w/v) as formulations prepared with a suitable vehicle (absolute
ethanol:water 7:3 (v/v) mixture, EtOH) was shown to have no skin sensitization
potential in the Local Lymph Node Assay. - Executive summary:
The aim of this study was to evaluate the skin sensitization potential of Ammonium Adipate
following dermal exposure in the Local Lymph Node Assay.
Preliminary tests were performed according to the relevant guidelines to find an appropriate
vehicle and the maximum applicable concentration.
The maximum soluble concentration in vehicles preferred in the LLNA was determined
according to the relevant guidelines. No adequate solubility was achieved with the most
preferred vehicles, but the test item was soluble in absolute ethanol:water 7:3 (v/v) mixture
(EtOH) with a maximum concentration of 5 % (w/v). As no significant adverse effects
(irritation or systemic toxicity) were observed in the Dose Range Finding test at this
maximum soluble concentration the test item was examined in the LLNA at concentrations
of 5 %, 2.5 %, 1 % and 0.5 % (w/v) as formulations in EtOH.
An appropriate positive control (α-Hexylcinnamaldehyde, HCA), furthermore two negative
control groups dosed with the vehicles of the test and positive control groups, respectively,
were employed.
The positive control item [25 % (w/v) HCA in Acetone: Olive oil 4:1 (v/v) mixture (AOO)]
induced significant stimulation over the relevant control (SI = 5.1) thus confirming the
validity of the assay.
No mortality, significant treatment related effect on the body weights or other symptoms of
systemic toxicity were observed during the test. No signs of irritation (monitored by
observation of erythema) or any other local effects were observed at the treatment site (ears)
in any treatment group.
No significant lymphoproliferative response (SI≥3) compared to the relevant control
(EtOH) was noted for Ammonium Adipate at the tested concentrations. The observed
stimulation index values were 1.7, 1.0, 1.6 and 2.6 at test item concentrations of 5%, 2.5 %,
1 % and 0.5 % (w/v), respectively. No dose-related response was observed (p = 0.59,
r2= 0.16, evaluated by linear regression using SI values).
According to the evaluation criteria of the relevant guidelines, the lack of a significantly
increased lymphoproliferation (indicated by an SI≥3) up to the maximum attainable
concentration of 5 % (w/v, based on solubility) as well as the lack of a significant
dose-related response is considered as evidence that Ammonium Adipate is a not a skin
sensitizer.
In conclusion, under the conditions of the present assay, Ammonium Adipate tested at
the maximum attainable concentration of 5 % (w/v, based on solubility) and at
concentrations of 2.5 %, 1 % and 0.5 % (w/v) as formulations prepared with a suitable
vehicle (absolute ethanol:water 7:3 (v/v) mixture, EtOH) was shown to have no skin
sensitization potential in the Local Lymph Node Assay.
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