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Diss Factsheets
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EC number: 204-479-9 | CAS number: 121-54-0
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- Benzethonium chloride
- EC Number:
- 204-479-9
- EC Name:
- Benzethonium chloride
- Cas Number:
- 121-54-0
- Molecular formula:
- C27H42NO2.Cl
- IUPAC Name:
- benzyldimethyl(2-{2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy}ethyl)azanium chloride
- Test material form:
- solid: compact
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Sponsor’s identification: P4123
- Batch number: 3072-S
- Date received: 28 June 1995
- Purity: 99.5%
- Description: white powder
- Stability: Considered to be stable under conditions of shipment, storage, and use in this study.
- Storage Conditions: Room temperature in the dark
- Expiration date: no data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK,
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.78-2.92 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water (e.g. ad libitum): tab water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 59-74%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
Test system
- Vehicle:
- water
- Amount / concentration applied:
- For the purpose of this study the test material was diluted to a 0.1% solution in distilled water before use.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Details on study design:
- One rabbit was initially treated. A volume of 0.1 ml of the test material was instilled into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal effects were noted during the study. Iridial inflammation was noted in two treated eyes at the 1-hour observation. Minimal conjunctival irritation was noted in all treated eyes at the 1-hour observation and one treated eye at the 24-hour observation. No ocular effects were noted in two treated eyes at the 1-hour observation and the remaining treated eye at the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not produce positive criteria in any rabbit according to the GHS regulations. No symbol and P phrases are therefore required.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 and Method B5 of Commission Directive 92/69/EEC. A single instillation of a 0.1% solution of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and minimal conjunctival irritation. No ocular effects were noted in two treated eyes at the 24-hour observation and the remaining treated eye at the 48-hour observation. The test material did not meet the criteria for classification as irritant according to GHS regulations.
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