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EC number: 607-854-9 | CAS number: 2605-78-9
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- End points studied: Corneal opacity, corneal thickness and condition and fluorescein uptake.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Schedule 1 (Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by 2004/0994))
Test material
- Reference substance name:
- N,N-dimethyl-N-octylhydroxylamine
- EC Number:
- 607-854-9
- Cas Number:
- 2605-78-9
- Molecular formula:
- CH3(CH2)7N(CH3)2O
- IUPAC Name:
- N,N-dimethyl-N-octylhydroxylamine
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- N,N-dimethyloctan-1-amine
- Reference substance name:
- Methanol
- EC Number:
- 200-659-6
- EC Name:
- Methanol
- Cas Number:
- 67-56-1
- Molecular formula:
- CH4O
- IUPAC Name:
- Methanol
- Test material form:
- liquid: viscous
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Analytical purity: 82.3%
- Purity test date: Not available
- Lot/batch No.: GN-8
- Expiration date of the lot/batch: Not available
- Appearance: Amber coloured, extremely viscous liquid
- Storage: In the dark at room temperature
- Additional information on test material used for the study: It was attempted to purify the substance to a purity of >80% by using an alternative synthetic route, as opposed to the usual commercial route of synthesis which results in a purity of the substance of approximately 40% in water. This alternative synthetic route generated the substance at 82.3% purity, however it also generated an impurity (methanol at 4.0%) which is not present in the commercial substance. Based on the classification and labelling of methanol, it is considered that this additional impurity would not have an influence on any of the endpoints discussed in this dossier other than the acute oral toxicity study. Therefore all studies (including the one covering this endpoint) contained in this dossier (other than the acute oral toxicity study) were conducted on the 82.3% pure substance containing the 4.0% methanol impurity. The acute oral toxicity study has been conducted on the commercially generated substance at a purity of approximately 40% in water.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1ml undiluted
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 60, 120, 180 and 240 minutes for all tests except Fluorescein uptake, which was measured at 240 minutes.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 20ml saline at approximately 32°C
- Time after start of exposure: ten seconds
SCORING SYSTEM:
McDonald- Shadduck Score Systen
CORNEA: Measurement of cloudiness grading:
0 = Normal cornea. Appears with the slit-lamp as having a bright grey line on the epithelial surface and a bright grey appearance of the stoma
1 = Some loss of transparency. Only the anterior half of the strom is involved as observed with an optical section of the slit-lamp. The underlying structures are clearly visible with diffuse illumination, although some cloudinedd can be readily apparent with diffuse illumination.
2 = Moderate loss of transparency. In addition to involving the anterior stroma, the cloudiness extends all the way to the endothelium. The stroma has lost its mable-like appearance and is homogeneously white. With diffues illumination, underlying structures are just visible.
3= Involvement of the entire thickness of the stroma. With the optical section cannot clearly visualise the endothelium. With the diffuse illumination, the underlying structures cannot be seen.
The surface of the cornea relative to the area of cloudiness is divided into five grades from 0 to 4.
0 = Normal cornea with no area of cloudiness
1 = 1 to 25% area of stromal cloudiness
2 = 26% to 50% area of stromal cloudiness
3 = 51% to 75% area of stromal cloudiness
4 = 76 to 100% area of stromal cloudiness
FlOURESCEIN
0 = Absence of flourescein staining
1 = Slight flourescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail
2 = Moderate flourescein staining confined to a small focus. With diffuse illumination the underlying structures are clearly visible, although there is some loss of detail.
3 = Marked flourescein staining. Staining may involve a larger portion of the cornea. With diffuse illumination underlying structures are barely visible but are not completely obliterated.
4 = Extreme flourescein staining. With diffuse illumination the underlying structures cannot be seen.
TOOL USED TO ASSESS SCORE: hand-slit lamp, biomicroscope and fluorescein
-Test material administration:
Eye held in perspex clamp, stored in superfusion apparatus irrigated with a saline drip. Clamp and eye removed from superfusion chamber then placed in petri dish Test material applied as evenly as possible over cornea. Washed of after 10 seconds with 20ml of saline solution 32°C. Returned to superfusion chamber still in clamp and a saline drip repositioned to irrigate the eye.
-Observations
Corneal cloudiness was observed pre-enucleation, post equilibration and at 60, 120, 180 and 240 minutes following treatment.
Examination of the eye via a slit-lamp biomicroscope. Thickness of cornea was measured by an ultrasonic pachymeter. A measurement was made at the optical centre and at four other locations at the apex of the cornea. A mean value was calculated. These observations were taken pre-enucleation, post equilibration and at 60, 120, 180 and 240 minutes following treatment.
Condition of the cornea was assessed at 60, 120, 180 and 240 minutes following treatment with a slit-lamp biomicroscope.
The uptake of flourescein was assessed pre-enucleation, post equilibration and 240 minutes following treatment. This was carried out using a cobalt blue filter of the slit-lamp biomicroscope after the addition of Flourescein Sodium drops.
These observations were graded with the above stated criteria.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1h to 4h post exposure
- Value:
- >= 1 - <= 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 1h post exposure
- Value:
- ca. 68.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 2h post exposure
- Value:
- ca. 101.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 4h post exposure
- Value:
- ca. 137.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1h to 4h post exposure
- Value:
- ca. 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
Individual Scores for Corneal Opacity
Test eyes |
Control eyes |
|||||||||||||||||||
Chamber Number |
6A |
8A |
10A |
7A |
9A |
|||||||||||||||
Time After Treatment (mins) |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
60 |
120 |
180 |
240 |
Degree of Corneal Opacity |
1+ |
1+ |
2+ |
2+ |
1+ |
1+ |
2+ |
2+ |
1+ |
1+ |
2+ |
2+ |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Corneal Opacity |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
+ = Meets or exceeds cut-off value indicating a severe ocular irritant.
Individual Measurements for Corneal thickness (µm)
Test Eyes |
||||||||||||||||||||||||||
Time After Treatment (mins) |
60 |
120 |
180 |
240 |
||||||||||||||||||||||
Corneal position |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
||
Chamber Number |
6A |
698 |
648 |
650 |
649 |
654 |
659.8 |
799 |
788 |
771 |
747 |
688 |
758.6 |
894 |
864 |
884 |
914 |
789 |
869.2 |
953 |
926 |
951 |
899 |
827 |
911.2 |
|
8A |
533 |
549 |
608 |
645 |
622 |
591.4 |
679 |
711 |
743 |
735 |
705 |
714.6 |
805 |
814 |
844 |
802 |
788 |
810.6 |
840 |
851 |
900 |
861 |
816 |
853.6 |
||
10A |
583 |
590 |
643 |
615 |
631 |
6112.4 |
792 |
702 |
768 |
791 |
701 |
750.8 |
865 |
722 |
842 |
855 |
743 |
815.4 |
888 |
835 |
918 |
868 |
798 |
861.4 |
Control Eyes |
||||||||||||||||||||||||||
Time After Treatment (mins) |
60 |
120 |
180 |
240 |
||||||||||||||||||||||
Corneal position |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
oc |
1 |
2 |
3 |
4 |
Mean |
||
Chamber Number |
7A |
384 |
376 |
372 |
377 |
373 |
376.4 |
374 |
369 |
368 |
365 |
370 |
369.2 |
378 |
374 |
369 |
372 |
369 |
372.4 |
386 |
388 |
370 |
385 |
378 |
381.4 |
|
9A |
404 |
398 |
377 |
368 |
371 |
383.6 |
404 |
401 |
387 |
385 |
383 |
392.0 |
410 |
401 |
381 |
376 |
380 |
389.6 |
406 |
398 |
383 |
375 |
374 |
387.2 |
oc = optical centre
Determination of Corneal Swelling (%)
Test eyes |
|||||||||||
Chamber Number |
Observation Period (mins) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (mins) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (mins) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
6A |
Post equilibriation |
367.6 |
N/A |
8A |
Post equilibriation |
360.6 |
N/A |
10A |
Post equilibriation |
376.2 |
N/A |
60 Post treatment |
659.8 |
79.5 |
60 Post treatment |
591.4 |
64.0 |
60 Post treatment |
612.4 |
62.8 |
|||
120 Post treatment |
758.6 |
106.4 |
120 Post treatment |
714.6 |
98.2 |
120 Post treatment |
750.8 |
99.6 |
|||
180 Post treatment |
869.2 |
136.5 |
180 Post treatment |
810.6 |
124.8 |
180 Post treatment |
815.4 |
116.7 |
|||
240 Post treatment |
911.2 |
147.9 |
240 Post treatment |
853.6 |
136.7 |
240 Post treatment |
861.4 |
129.0 |
Control eyes |
|||||||
Chamber Number |
Observation Period (mins) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
Chamber Number |
Observation Period (mins) |
Mean Corneal Thickness (µm) |
Corneal Swelling (%)a |
7A |
Post equilibriation |
354.8 |
N/A |
9A |
Post equilibriation |
366.6 |
N/A |
60 Post treatment |
376.4 |
6.1 |
60 Post treatment |
383.6 |
4.6 |
||
120 Post treatment |
369.2 |
4.1 |
120 Post treatment |
392.0 |
6.9 |
||
180 Post treatment |
372.4 |
5.0 |
180 Post treatment |
389.6 |
6.3 |
||
240 Post treatment |
381.4 |
7.5 |
240 Post treatment |
387.2 |
5.6 |
a = % corneal swelling = (((mean corneal thicknes post-treatment)-(mean corneal thickness pre-treatment))/mean corneal thicknes pre-treatment)x100
N/A = Not applicable
+ = Exceeds cut-off value and therefore indicates a severe eye irritant.
Summary of tablulated corneal swelling results:
Test eyes:
Mean corneal swelling 1 hours post-treatment = 68.8%+
Mean corneal swelling 2 hours post-treatment = 101.4%+
Mean corneal swelling 4 hours post-treatment = 137.9%+
Control eyes:
Mean corneal swelling 1 hour post-treatment = 5.4%
Mean corneal swelling 2 hours post-treatment = 5.5%
Mean corneal swelling 4 hours post-treatment = 6.6%
Corneal Epithelium Condition:
Test Eyes |
||||
Chamber Number |
Time After Treatment (mins) |
|||
60 |
120 |
180 |
240 |
|
6A |
Sloughing + |
Sloughing + |
Sloughing + |
Sloughing + |
8A |
||||
10A |
Sloughing + |
Sloughing + |
Control Eyes |
||||
Chamber Number |
Time After Treatment (mins) |
|||
60 |
120 |
180 |
240 |
|
7A |
||||
9A |
+ = Meets cut-off value indicating a severe ocular irritant
Individual Scores for Fluorescein Uptake (240 Minutes Post Dosing)
Test eyes |
Control eyes |
||||
Chamber Number |
6A |
8A |
10A |
7A |
9A |
Intensity of Flourescein Uptake |
2+ |
2+ |
2+ |
0 |
0 |
Area of Flourescein Uptake |
4 |
4 |
4 |
0 |
0 |
+ = Meets or exceeds cut-off value indicatin a severe ocular irritant
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- From the in vitro tests, the test substance has proved to have a high ocular irritancy.
- Executive summary:
Introduction: It is a legal and ethical duty under the animals (scientific Procedure) Act 1986 that, in the interest of animal welfare, the unnecessary use of animals is avoided, and that any testing which is likely to produce severe effects in a rabbit eye and to confirm this initial assessment, a Rabbit Enucleated Eye Test (REET) was performed.
This step-wise procedure is in accordance with OECD Test guideline 405, UK Home Office regulations and Safepharm Laboratories Ltd. Ethical Testing strategy.
A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The reults of the study are believed to be of value in predicting the occular irritation potential of the test material in man.
Methods: 0.1ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 deg C +/- 1.5 degC within the superfision chamber. A further two enucleated eyes were treated, for control purposes, with saline solution ( 0.9% Sodium Chloride)
Conclusion: Following assessment of the data for all endpoints the test material was considered to have the potential to cause severe ocular irritancy in vivo. The in vivo eye irritation study is therefore not required.
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