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EC number: 265-019-0 | CAS number: 64690-19-3
- 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:
- Experimental start date 15 February 2018, Experimental completion date 15 February 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-octylpyridin-4-amine
- EC Number:
- 265-019-0
- EC Name:
- N-octylpyridin-4-amine
- Cas Number:
- 64690-19-3
- Molecular formula:
- C13H22N2
- IUPAC Name:
- N-octylpyridin-4-amine
Constituent 1
- Specific details on test material used for the study:
- 3.1 Test Item and Supporting Information
Information as provided by the Sponsor.
Identification: N-Octyl-4-pyridinamine
CAS Number: 64690-19-3
Batch: 80030735B
Purity: 99.6%
Physical state/Appearance: White solid
Expiry Date: 28 November 2018
Storage Conditions: room temperature in the dark
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Source of Bovine Eyes
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.
Preparation of Corneas
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.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
Selection of Corneas and Opacity Reading
The medium from both chambers of each holder was replaced with fresh complete EMEM.
A pre treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated.
Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Test Item Preparation and Analysis
For the purpose of this study the test item was prepared as a 20% w/v solution in sodium chloride 0.9% w/v.
The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
Reference Item Preparation
The negative control item, sodium chloride 0.9% w/v, was used as supplied.
The positive control item, Imidazole, was used as a 20% w/v solution in sodium chloride 0.9% w/v. - Duration of treatment / exposure:
- 240 minutes.
- Duration of post- treatment incubation (in vitro):
- 90 minutes (permeability evaluation)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 67.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in the table below.
Corneal Epithelium Condition
The condition of each cornea is given in the table below.
The corneas treated with the test item were cloudy 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.
In VitroIrritancy Score
TheIn Vitroirritancy scores are summarized as follows:
Treatment |
In VitroIrritancy Score |
Test Item |
67.8 |
Negative Control |
1.1 |
Positive Control |
109.8 |
Criteria for an Acceptable Test
The positive controlIn VitroIrritancy Score was within the range of 65.1 to 123.3. The positive control acceptance criterion was therefore satisfied.
The negative control gave opacity of ≤2.4 and permeability ≤0.072. The negative control acceptance criteria were therefore satisfied.
Conclusion
Category 1. UN GHS or EU CLP Causes serious eye damage.
Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD492) |
In VitroIrritancy Score |
||||
Pre-Treatment |
Post-Treatment |
Post-Treatment-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
2 |
2 |
3 |
1 |
|
0.013 |
|
|
3 |
2 |
3 |
1 |
|
0.002 |
|
|
|
6 |
4 |
5 |
1 |
|
0.006 |
|
|
|
|
|
|
1.0* |
|
0.007¨ |
|
1.1 |
|
Positive |
7 |
3 |
78 |
75 |
74.0 |
1.960 |
1.953 |
|
10 |
1 |
84 |
83 |
82.0 |
1.950 |
1.943 |
|
|
11 |
2 |
73 |
71 |
70.0 |
3.005 |
2.998 |
|
|
|
|
|
|
75.3· |
|
2.298· |
109.8 |
|
Test Item |
12 |
3 |
68 |
65 |
64.0 |
0.812 |
0.805 |
|
13 |
1 |
58 |
57 |
56.0 |
0.627 |
0.620 |
|
|
14 |
2 |
53 |
51 |
50.0 |
0.813 |
0.806 |
|
|
|
|
|
|
56.7· |
|
0.744· |
67.8 |
OD= Optical density * = Mean of the post-treatment -pre‑treatment values ¨= Mean permeability ·= Mean corrected value
Corneal Epithelium Condition Post Treatment
Treatment |
Cornea Number |
Observation |
Negative Control |
2 |
Clear |
3 |
Clear |
|
6 |
Clear |
|
Positive Control |
7 |
Cloudy |
10 |
Cloudy |
|
11 |
Cloudy |
|
Test Item |
12 |
Cloudy |
13 |
Cloudy |
|
14 |
Cloudy |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item is classified as its in-vitro irritancy score is >55 (67.8)
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