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EC number: 948-061-0 | CAS number: -
- 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:
- 23-26 October 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline 405 with deviations: age at study initiation, individual animal weights, environmental conditions not reported; non-ocular local and systemic adverse effects not followed
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- age at study initiation, individual animal weights, environmental conditions not reported; non-ocular local and systemic adverse effects not followed
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- EC Number:
- 948-061-0
- Molecular formula:
- C18 H40 NO+ Cl- ; C20 H44 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H48 NO+ Cl-
- IUPAC Name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- 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: Chimex / Batch M 303- Physical state: Yellowish limpid liquid- Date received: October 9, 1995- Purity test date: July 27, 1995STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Stored at room temperature, away from the light and heat
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: elevage ROUGIER (63370 - St Gervais, d'Auvergne.- Weight at study initiation: 2 kg (average weight)- Housing: Animals were housed individually on floor grids.- Diet: Complete pelleted rabbit maintenance diet Energie H326 (COFNA, 37000 - Tours, France), ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS: Environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline.IN-LIFE DATES: 23-26 October 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL - Amount(s) applied (volume or weight with unit): 0.1 mL/eye - Concentration (if solution): Undiluted
- Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation of the test substance. If lesions are too severe, to avoid unnecessary pain, animal is euthanatized.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENTTest substance was placed at a dose of 0.1 mL in the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second in order to prevent loss of the test substance. The other eye, which remains untreated, serves as a control. After a one hour period of contention, the animals were returned to its individual cage.REMOVAL OF TEST SUBSTANCE- Washing: NoSCORING SYSTEM: According to OECD Guideline 405TOOL USED TO ASSESS SCORE: - Ocular reactions were performed with a U. V. and white magnification light. After recording the observations at 24 h, the eyes of all rabbits were examined with the aid of fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- impossible reading
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- One hour after instillation of the substance, very important irritation reactions were noticed at the level of the conjunctivae. The intensity of the conjunctival lesions made it not possible the evaluation of the iris and cornea reactions. A serious damage of iris and cornea was observed in one animal 24 hours after instillation. At the 72 hours reading conjunctival lesions remained unchanged, inflammatory phenomena increased. To avoid unnecessary pain, animals were sacrificed.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Results of eye irritation
Animal no. | 4621 | 4622 | 4623 | |||||||||||||||
Observation points
| Conjunctiva | Iris | Cornea | Conjunctiva | Iris | Cornea | Conjunctiva | Iris | Cornea | |||||||||
A | B | C | D | E | F | A | B | C | D | E | F | A | B | C | D | E | F | |
D1 (1 h) | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * |
24 h | 4 | 2 | 3 | * | * | * | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | 2 | 4 | * |
48 h | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * |
72 h | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * | 4 | 3 | 3 | * | * | * |
M | 4 | 2.7 | 3 | - | - | - | 4 | 3 | 3 | - | - | - | 4 | 3 | 3 | - | - | - |
* impossible reading; A: Chemosis; B: Discharge; C: Redness; D: Iris lesion; E: Opacity; F: Opacity area; M: Mean
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions, test substance is classified as "Irreversible effects on the eye (Category 1)" according to the Regulation (EC) N° 1272-2008 (CLP) and GHS.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted test substance in their right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for about one second to avoid any loss of test substance. At 24 h after treatment, fluorescein solution was instilled into the eyes and they were examined under UV-lamp to detect possible corneal damage. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the method of OECD Guideline 405.
One hour after instillation of the substance, very important irritation reactions were noticed at the level of the conjunctivae. Severity of conjunctival reactions (Chemosis with lids more than half closed) made it not possible the evaluation of cornea and iris lesions. 24 h later, serious lesions of iris and cornea were observed in one rabbit. At the 72 h reading conjunctival lesions remained unchanged, inflammatory phenomena increased. To avoid unnecessary pain, animals were sacrificed.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 3.0, 3.0, 3.0 for conjunctivae score and 4.0, 4.0, 4.0 for chemosis score; no impossible reading for cornea and iris.
Under the test conditions, test substance is classified as "Irreversible effects on the eye (Category 1)" according to the Regulation (EC) N° 1272-2008 (CLP) and GHS.
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