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EC number: 700-414-8 | CAS number: 23328-71-4
- 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:
- 10 September 2007 to 1 October 2007.
- 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 the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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)
- Remarks:
- Date of inspection: 30 August 2005 Date of Signature: 21 November 2005
Test material
- Reference substance name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- EC Number:
- 700-414-8
- Cas Number:
- 23328-71-4
- Molecular formula:
- C24H52ClNO
- IUPAC Name:
- trimethyl[3-(octadecyloxy)propyl]azanium chloride
- Details on test material:
- - Name of test material (as cited in study report): 3-Octadecyloxypropyl-N,N,N-trimethylammonium chloride
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: white solid
- Physical state: solid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Exp. I-070518
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported.
- Storage condition of test material: room temperature in the dark.
- Other: Not reported.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation: Twelve to 20 weeks old.
- Weight at study initiation: 2.59 kg.
- Housing: The animal was housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum throughout the study.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and 12 hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye in the exposured animal was used for control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 67 mg.
VEHICLE
Not applicable. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following the grading in the test guideline. The result was classified according to EU classification system.
TOOL USED TO ASSESS SCORE: A standard ophthalmoscope.
OTHERS
Immediately before the start of the test, both eyes of the provisionally selected test rabbit were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. An animal free of ocular damage was used. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1. After consideration of the ocular responses produced in this animal, no additional animals were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 66576 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: Max score was observed at 24, 48 and 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 66576 Male
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Max score was observed at 24, 48 and 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 66576 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Max score was observed at 24 and 48 hours
- Irritant / corrosive response data:
- Individual scores for ocular irritation are given in Table 2.
Scattered or diffuse corneal opacity and iridial inflammation were noted in the treated eye one hour after treatment and at subsequent observations. Vascularisation, with a generalised ingrowth of vessels for approximately 3 mm, was noted in the treated eye at the 14 and 21-day observations.
Severe conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48 hour observations with moderate conjunctival irritation at the 72-hour, 7, 14 and 21 day observations.
A pale area covering the nictitating membrane was noted in the treated eye at the 24, 48, 72 hour, 7 and 14-day observations. A small area of haemorrhage on the upper and lower area of nictitating membrane was noted in the treated eye at the 72 hour, 7, 14 and 21-day observations. Ectropion was noted in the treated eye at the 14 and 21-day observations.
The persistence of reactions in the treated eye at the 21 day observation was considered to be indicative of irreversible ocular damage. - Other effects:
- Not reported.
Any other information on results incl. tables
Table 2 Individual Scoresfor Ocular Irritation
Rabbit Number and Sex |
66576 Male |
||||||
IPR= 3 |
|||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
14 Days |
21 Days |
CORNEA |
|
|
|
|
|
|
|
Degree of Opacity |
1 |
1 |
1 |
1 |
1 |
1V |
1V |
Area of Cornea Involved |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
IRIS |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
CONJUNCTIVA |
|
|
|
|
|
|
|
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
Chemosis |
3 |
3 |
3 |
2 |
2 |
2 |
2 |
Discharge |
3 |
3 |
3 |
2 |
2 |
2 |
2 |
Other |
|
P |
P |
PH |
PH |
PHEc |
HEc |
IPR= Initial pain reaction
H = Small area of haemorrhage on upper and lower area of nictitating membrane
P = Pale area covering nictitating membrane
V = Vascularisation, with a generalised ingrowth of vessels, approximately 3 mm in length
Ec = Ectropion
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye (based on one rabbit only). The test substance is classified as R41 Risk of serious damage to eyes under Council Directive 67/548/EEC and Category 1 H318: cause serious eye damage under Regulation (EC) No 1272/2008.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
§ Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC
Result. A single application of the test material to the non-irrigated eye of one rabbit produced scattered or diffuse corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were vascularisation, with a generalised ingrowth of vessels for approximately 3 mm, a pale area covering the nictitating membrane, a small area of haemorrhage on upper and lower area of nictitating membrane and ectropion. The persistence of reactions in the treated eye at the 21‑day observation was considered to be indicative of irreversible ocular damage.
Conclusion. The test material produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye (based on one rabbit only). The test substance is classified as R41 Risk of serious damage to eyes under Council Directive 67/548/EEC and Category 1 H318: cause serious eye damage under Regulation (EC) No 1272/2008.
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