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EC number: 254-104-8 | CAS number: 38725-13-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20 March 2018 to 23 July 2018
- 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 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)
- Version / remarks:
- adopted 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Triisononylamine
- EC Number:
- 254-104-8
- EC Name:
- Triisononylamine
- Cas Number:
- 38725-13-2
- Molecular formula:
- C27H57N
- IUPAC Name:
- tris(7-methyloctyl)amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: batch no. 99671, supplied by the sponsor
- Expiration date of the lot/batch: 9 October 2019
- Purity test date:6 November 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a closed vessel, at room temperature (20±5°C)
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The item is a liquid substance. It was tested directly, without dilution or preparation of a solution
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Neat, as supplied
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Bos primigenius Taurus (fresh bovine corneas)
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: slaughterhouse Muller Fleish
- Number of animals: 9 eyes were used
- Characteristics of donor animals (e.g. age, sex, weight): The cattle were between 12 and 60 months
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour
- Time interval prior to initiating testing: Eyes were examined and initiated the day of the arrival
- indication of any existing defects or lesions in ocular tissue samples: no lesions
- Indication of any antibiotics used: not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µL
- Concentration (if solution): pure
VEHICLE
No vehicle was used - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours at 32±1°C
- Number of animals or in vitro replicates:
- Triplicates were used per condition
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 ± 1 °C.
On the day of the assay, the MEM without phenol red was supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum (= complete MEM) and stored in a water bath at 32 ± 1 °C. The same was performed with the MEM with phenol red, but without addition of sodium bicarbonate.
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM (32 ± 1 °C) without phenol red was filled. The holders were then incubated for 1 hour in the incubation chamber at 32 ± 1 °C
QUALITY CHECK OF THE ISOLATED CORNEAS
After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used.
NUMBER OF REPLICATES
Triplicates were sued per condition
NEGATIVE CONTROL USED
HBSS
POSITIVE CONTROL USED
Dimethylformamide
APPLICATION DOSE AND EXPOSURE TIME
750 µL of test substance or control substances were exposed for 10 minutes
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes 2 hours
REMOVAL OF TEST SUBSTANCE AND POST-EXPOSURE INCUBATION:
- Number of washing steps after exposure period: Exposure time of the test item on the corneas was 10 minutes at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 hours at 32 ± 1 °C (post-incubation).
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change of opacity value of each treated cornea with test item, positive control and negative control was calculated by subtracting the initial basal opacity from the post treat-ment opacity reading for each cornea.
The average change in opacity of the negative control cornea was calculated and this value was subtracted from the change in opacity of each treated cornea with test item and positive control to obtain a corrected opacity.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD492)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The IVIS of each replicate of the negative control was calculated from the following equa-tion:
IVIS = opacity difference + (15 x corrected OD492 value)
The IVIS of each replicate of the positive control and of the test item were calculated from the following equation:
IVIS = (opacity difference – mean opacity difference of the negative control) + [15 x (OD492 – mean OD492 of the negative control)]
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used:
IVIS.≤ 3 : No category
IVIS > 3 and ≤ 55 : No prediction can be made
> 55 : Eye damage Category I
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item Triisononylamine (Mean)
- Value:
- 0.55
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No damage
DEMONSTRATION OF TECHNICAL PROFICIENCY: the positive control condition showed technical proficiency of the test system
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: valid
- Acceptance criteria met for positive control: valid
- Range of historical values if different from the ones specified in the test guideline: valid
Any other information on results incl. tables
Table 1 Results : IVIS
Test Group |
IVIS |
Mean IVIS |
Relative Standard Deviation IVIS |
Negative Control |
1.20 |
1.05 |
12.64% |
0.95 |
|||
0.99 |
|||
Test Item |
-1.27 |
0.55 |
384.46% |
0.07 |
|||
2.84 |
|||
Positive Control |
71.14 |
72.16 |
9.35% |
79.36 |
|||
65.97 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental condition of the study, the test item Triisononylamine showed no effects on the cornea of the bovine eye. The calculated IVIS was 0.55.
According to CLP criteria, a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage. - Executive summary:
This GLP compliant in vitro study was performed to assess the corneal damage potential of Triisononylamine by quantitative measurements of changes in opacity and permeability in a bovine cornea according to OECD 437 Guideline method.
Bovine corneas were used. They were collected from slaughtered cattle that were between 12 and 60 months old. The test item Triisononylamine was brought onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative control showed no irritating effect on the cornea and the calculated IVIS (In Vitro Irritancy Score) is 1.05.
Dimethylformamide (DMF) undiluted was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current historical mean. The calculated IVIS was 72.16.
Under the conditions of this study, the test item Triisononylamine showed no effects on the cornea of the bovine eye. The calculated IVIS was 0.55. According to CLP criteria, a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
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