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EC number: 800-906-3 | CAS number: 1402434-48-3
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 11 April, 2013 to 19 April, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the OECD Guideline and EU Method in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 72906-09-3
- Cas Number:
- 72906-09-3
- IUPAC Name:
- 72906-09-3
- Reference substance name:
- Morpholine, 4-C12-14-alkyl derivs.
- EC Number:
- 800-906-3
- Cas Number:
- 1402434-48-3
- Molecular formula:
- Not applicable
- IUPAC Name:
- Morpholine, 4-C12-14-alkyl derivs.
- Details on test material:
- - Name of test material (as cited in study report): C12-14 alkylmorpholine
- Analytical purity: 98.3%:
- Lot/batch No.: S-001312
- Expiration date of the lot/batch: 05 December 2017
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White (Hsdlf:NZW)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.49 or 2.83 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad global rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon UK (ad libitum)
- Water: Free access to mains drinking water
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70%
- Air changes: 15 changes/h
- Photoperiod: The lighting was controlled by a time switch to give 12 h continuous light (06:00 to 18:00) and 12 h darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approx 1 h and 24, 48 and 72 h following treatment.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one and 24 h after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 48 h observation. Both treated eyes appeared normal at the 72 h observation.
- Other effects:
- Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 1. individual scores and individual total scores for ocular irritation:
Rabbit number and sex |
73111 Male |
73124 Male
|
||||||
IPR = 2 |
IPR = 2
|
|||||||
Time after treatment |
1 h
|
24 h |
48 h
|
72 h
|
1 h
|
24 h
|
48 h
|
72 h
|
Cornea |
||||||||
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
||||||||
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
||||||||
A = Redness |
2
|
1 |
1 |
0 |
2 |
2 |
1 |
0 |
B = Chemosis
|
1
|
1 |
1 |
0 |
2 |
1 |
1 |
0 |
C = Discharge |
0
|
1 |
0 |
0 |
1 |
1 |
0 |
0 |
Score (A + B + C) x 2 |
6
|
6 |
4 |
0 |
10 |
8 |
4 |
0 |
Total Score |
6
|
6 |
4 |
0 |
10 |
8 |
4 |
0 |
Table 2. Individual total scores and group mean scores for ocular irritation:
Rabbit number and sex |
Individual total scores at: |
|||
1 h |
24 h |
48 h |
72 h |
|
73111 Male |
6 |
6 |
4 |
0 |
73124 Male |
10 |
8 |
4 |
0 |
Group total |
16 |
14 |
8 |
0 |
Group mean score |
8 |
7 |
4 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the test substance produced mild irritation which was fully reversible with 72 h after treatment.
- Executive summary:
The study was performed to assess the irritancy potential of C12-14 alkylmorpholine to the eye of the New Zealand White rabbit in accordance with the OECD Guideline 405 and EU Method B.5 in compliance with GLP.
A volume of 0.1 mL of the test substance was placed into the conjunctival sac of the right eye. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released. The left eye remained untreated and was used for control purposes. Theassessment of ocular damage/irritation was made approx 1 h and 24, 48 and 72 h following treatment.
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in the other treated eye one and 24 h after treatment. Minimal conjunctival irritation was noted in both treated eyes at the 48 h observation. Both treated eyes appeared normal at the 72 h observation. Both animals showed expected gain in body weight during the study. The maximum group mean score was calculated to be 8.0.
Under the study conditions, the test substance produced mild irritation which was fully reversible with 72 h after treatment.
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