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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Remarks:
- ex vivo
- 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 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 25 June 2018
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- chicken
- Strain:
- other: ROSS 308
- Remarks:
- chiken eyes
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 mg / eyes
- Duration of treatment / exposure:
- 10 s
- Observation period (in vivo):
- 30, 75, 120,180 and 240 minutes after the post-treatment rinse.
- Duration of post- treatment incubation (in vitro):
- na
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Treatment
After the zero reference measurements, one out of three test item treated eyes was taken out
of its chamber and placed on a layer of tissue with the cornea facing upwards. The eye was
held in horizontal position over a container to catch waste, while the test item was applied
onto the centre of the cornea. The test item was applied in an amount of 30 mg by
attempting to cover the cornea surface uniformly with the test substance, while taking care
not to damage or touch the cornea with the application equipment. This procedure was
repeated for each test item treated eye.
The three positive control eyes were treated in a similar way with 30 mg Imidazole.
One negative control eye was treated with saline solution. The saline solution was applied in
a volume of 30 µL from micropipette, in such a way that the entire surface of the cornea was
covered with negative control, taking care not to damage or touch the cornea with the
application equipment.
Test item removal
The time of application was monitored, then after an exposure period of 10 seconds from the
end of the application the cornea surface was rinsed thoroughly with 20 mL saline solution
at ambient temperature, while taking care not to damage the cornea but attempting to
remove all the residual test item if possible. The eye in the holder was then returned to its
chamber. The time while the eye was out of the chamber was limited to the minimum.
Imidazole was stuck on the corneas’ surface in all eyes at 30 minutes after the posttreatment rinse. The gentle rinsing with 20 mL saline was performed in all Imidazole treated
eyes after the 30, 75, 120 and 180 minutes of observation. Imidazole treated cornea surfaces
were not totally cleared at 240 minutes after the post-treatment rinse in the first and
additional experiment.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Overall ICE Class: 2xI, 1xII
- Other effects / acceptance of results:
- In this ICET, Ammonium Adipate did not cause ocular corrosion or severe irritation in the
enucleated chicken eyes in both cases. The overall ICE class was 2xI, 1xII in the first
experiment and 3x I in the additional experiment.
Positive and negative controls showed the expected results. The experiment is considered to
be valid.
In this in vitro eye irritation study, using the Isolated Chicken Eye model with
Ammonium Adipate, no ocular corrosion or severe irritation potential was observed.
The overall ICE score was 2xI, 1xII in the first and it was 3xI in the additional
experiment.
According to the guideline OECD 438, Ammonium Adipate is categorized as “No
Category”.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this ICET, Ammonium Adipate did not cause ocular corrosion or severe irritation in the
enucleated chicken eyes in both cases. The overall ICE class was 2xI, 1xII in the first
experiment and 3x I in the additional experiment.
Positive and negative controls showed the expected results. The experiment is considered to
be valid.
In this in vitro eye irritation study, using the Isolated Chicken Eye model with
Ammonium Adipate, no ocular corrosion or severe irritation potential was observed.
The overall ICE score was 2xI, 1xII in the first and it was 3xI in the additional
experiment.
According to the guideline OECD 438, Ammonium Adipate is categorized as “No
Category”. - Executive summary:
The purpose of this Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular
corrosivity and irritancy of the test item Ammonium Adipate by its ability to induce toxicity
in enucleated chicken eyes. The test compound was applied in a single dose (30 mg/eye)
onto the cornea of isolated chicken eyes in order to potentially classify the test compound as
either 1: causing "serious eye damage" (category 1 of the Globally Harmonised System for
the Classification and Labelling of Chemicals (GHS)), or 2: not requiring classification for
eye irritation or serious eye damage according to the GHS. Tested corneas were evaluated
pre-treatment and at approximately 30, 75, 120, 180, and 240 minutes after the posttreatment rinse. The endpoints evaluated were corneal opacity, swelling, fluorescein
retention, and morphological effects. All of the endpoints, with the exception of fluorescein
retention (which was determined only at pre-treatment and 30 minutes after test substance
exposure) were determined at each of the above time points.
According to the first experiment results the test item showed negative outcome (GHS NC).
Based on the OECD 438 additional experiment necessary to confirm or discard the negative
outcome.
The test item and Imidazole (positive control) was grounded before use in the study. The test
item and positive control applied in an amount of 30 mg/eye by powdering the entire surface
of the cornea attempting to cover the cornea surface uniformly with the test substance or
positive control. Three test item treated eyes and three positive control eyes were used in in
each experiment.
One negative control eye was treated with 30 µL saline solution in each experiment.
After an exposure period of 10 seconds from the end of the application the cornea surface
was rinsed thoroughly with ~20 mL saline solution at ambient temperature and this
procedure was repeated for each eye.
Imidazole was stuck on the corneas’ surface in all eyes at 30, 75, 120, 180 and 240 minutes
after the post-treatment rinse in the first and additional experiment. Imidazole treated cornea
surfaces were not totally cleared at 240 minutes after the post-treatment rinse in the first and
additional experiment.
In this ICET, Ammonium Adipate did not cause ocular corrosion or severe irritation in the
enucleated chicken eyes in both cases. The overall ICE class was 2xI, 1xII in the first
experiment and 3x I in the additional experiment.
Positive and negative controls showed the expected results. The experiment is considered to
be valid.
In thisin vitroeye irritation study, using the Isolated Chicken Eye model with
Ammonium Adipate, no ocular corrosion or severe irritation potential was observed.
The overall ICE score was 2xI, 1xII in the first and it was 3xI in the additional
experiment.
According to the guideline OECD 438, Ammonium Adipate is categorized as “No
Category”.
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