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EC number: 288-312-5 | CAS number: 85711-52-0
- 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
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- 16 April 2015 - 06 December 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amides, from diethylenetriamine and hydrogenated palm oil
- EC Number:
- 810-543-2
- Cas Number:
- 1618093-67-6
- Molecular formula:
- n/a
- IUPAC Name:
- Amides, from diethylenetriamine and hydrogenated palm oil
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): Amidoamine (UVCB)
- Substance type: Amidoamine
- Chemical name: Glycerides, C14-20, reaction products with diethylenetriamine (preliminary naming)/Amides, from diethylenetriamine and hydrogenated palm oil
- CAS 85409-11-6/1618093-67-6
- Physical state: pale yellowish solid at 20 °C
- Batch No.: K8 4309 L481
- Expiry date of batch: 09 March 2017
- Purity: 100 % (UVCB)
- Storage condition of test material: Room temperature, protected from light
- Stability: stable under test conditions
Constituent 1
- Specific details on test material used for the study:
- Test item without emulsifier was investigated.
Amidoamine (UVCB)
Pulcra ID: DE07_2014_012_BEL66 (amidoamine without emulsifier)
Physical state: pale yellowish solid at 20 °C
Batch No.: K8 4309 L481
Expiry date of batch: 09 March 2018
Purity: 100 % (UVCB)
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared
immediately on arrival.
Test system
- Vehicle:
- other: 20% w/v solution in 0.9% w/v sodium chloride solution
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- the test item was ground to a powder and prepared as a 20% w/v solution in 0.9% w/v sodium chloride solution. 0.75 mL of the test item preparation or control items were applied to the appropriate corneas.
- Duration of treatment / exposure:
- Each cornea holder was incubated, anterior chamber uppermost, at 32 ± 1 ºC for 240 minutes. At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM without phenol red. The anterior chamber was refilled with fresh complete MEM without phenol red.
A post-treatment opacity reading was taken and each cornea was visually observed.
Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes. - Number of animals or in vitro replicates:
- Three corneas with opacity values close to the median value of all corneas were allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
- Details on study design:
- All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 240 minutes incubation
- Value:
- 0.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- In Vitro Irritancy Score: 1.8
- Positive controls validity:
- valid
- Remarks:
- In Vitro Irritancy Score: 68.8
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The positive control In Vitro Irritancy Score was within the range of 73.8 – 103.6. The positive control acceptance criterion was therefore satisfied.
The negative control gave opacity of ≤4.7 and permeability ≤0.085. The negative control acceptance criterion was therefore satisfied.
The corneas treated with the test item were clear post treatment.
The corneas treated with the negative control item were clear post treatment.
The corneas treated with the positive control item were cloudy post treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No category. Not requiring classification to UN GHS or EU CLP.
- Executive summary:
In a Klimisch 1 GLP study from Warren (2016) the potential of the test item to induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage using the Bovine Corneal Opacity and Permeability (BCOP) test method was investigated. The test item's In Vitro Irritancy Score was < 3. The test item was not considered to induce serious eye damage and is not requiring classification to UN GHS or EU CLP.
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