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EC number: 269-824-8 | CAS number: 68334-33-8
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1990-12-13 to 1990-12-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Although this study is guideline and GLP compliant and would normally be assigned a reliability of 1 (reliable without restrictions), this study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions).
- Justification for type of information:
- The primary component of all substances provide complete coverage of 68334-33-8. 68334-33-8 shares high structural similarity with 61789-80-8, 68783-78-8, 107-64-2, and 112-02-7. As 68334-33-8 is a UVCB its components encapsulate the other substances except for the counter ion (Cl-). In solution, the counter ions will dissociate from the parent structures. Therefore, we are comparing substances of equivalent nature. CAS 107-64-2 represents the C18 boundary of the 61789-80-8. Ignoring the salt component CAS 61789-80-8 is equivalent to CAS 68334-33-8. 68783-78-8 is a worst case of both 68334-33-8 and 61789-80-8 since it is unsaturated and the SP2 carbon-carbon bonds are of higher reactivity and a more likely site of metabolic activation. The primary component of CAS 112-02-7 is a substructure of all the other substances. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The primary component of all substances provide complete coverage of 68334-33-8. 68334-33-8 shares high structural similarity with 61789-80-8, 68783-78-8, 107-64-2, and 112-02-7. As 68334-33-8 is a UVCB its components encapsulate the other substances except for the counter ion (Cl-). In solution, the counter ions will dissociate from the parent structures. Therefore, we are comparing substances of equivalent nature. CAS 107-64-2 represents the C18 boundary of the 61789-80-8. Ignoring the salt component CAS 61789-80-8 is equivalent to CAS 68334-33-8. 68783-78-8 is a worst case of both 68334-33-8 and 61789-80-8 since it is unsaturated and the SP2 carbon-carbon bonds are of higher reactivity and a more likely site of metabolic activation. The primary component of CAS 112-02-7 is a substructure of all the other substances. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1-hour and 24-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: the ocular lesions noted after 24 hours in the rabbit were so severe that the animal was sacrificed for ethical grounds
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides
- EC Number:
- 295-835-2
- EC Name:
- Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides
- Cas Number:
- 92129-33-4
- Molecular formula:
- R2N+(CH3)2, Cl- with R is fatty alkyl with chainlengths C16-C18 (even numbered)
- IUPAC Name:
- N-C16-C18(even numbered)-alkyl-N,N-dimethyl-C16-C18(even numbered)-alkyl-1-aminium chloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage cunicole de Val de Selle, Prouzel, France.
- Weight at study initiation: 2,5 kg.
- Housing: individually in polystyren cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod: 12 hrs dark /12 hrs light
Test system
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.1ml previously melted at 20 - 25°C. - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 1 hour and 24 hours after instillation
- Number of animals or in vitro replicates:
- 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : eye not rinsed
SCORING SYSTEM: according to OECD guideline 405 (draize scoring system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1-hour and 24-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: the ocular lesions noted after 24 hours in the rabbit were so severe that the animal was sacrificed for ethical grounds
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked
- Irritant / corrosive response data:
- 1 hour then 24 hours after instillation of the test substance, the ocular reactions were severe and the conjunctival chemosis (score of 4) obscured the evaluation of the reactions at the iris and cornea. The flowing of a whitish purulent substance was also noted.
Some severe ocular lesions were expected at the next reading times but taking into consideration the severity of the lesions noted after 24 hours, the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental conditions, the test material was considered as severely irritating when administered by ocular route to rabbits.
- Executive summary:
The potential of the technical grade dehydrogenated tallow dimethylammonium, chlorides (78% active in isopropanol/water) to induce eye irritation was assessed in 1 rabbit according to the OECD guideline 405 in compliance with the principles of Good Laboratory Practice regulations. Taking into account the highly irritating effects observed in the acute dermal irritation/ corrosion test previously performed in rabbits, it was decided for ethical considerations, to perform the assay with one animal. A single dose of 0.1 mL of the test material was instilled into one eye, the other eye was not treated and served as control. The eyes were not rinsed after administration of the test item. Ocular reactions were observed 1 hour and 24 hours later.
1 hour then 24 hours after instillation of the test substance, the ocular reactions were severe and the conjunctival chemosis (score of 4) obscured the evaluation of the reactions at the iris and cornea. The flowing of a whitish purulent substance was also noted. Some severe ocular lesions were expected at the next reading times but taking into consideration the severity of the lesions noted after 24 hours, the animal was sacrificed for ethical grounds before the nature of the reactions concerning the iris and the cornea could have been checked. Under these experimental conditions, the test material was considered as severely irritating when administered by ocular route to rabbits.
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