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EC number: 279-791-1 | CAS number: 81646-13-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 23.04.2008-24.04.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405; EU B.5). For justification for read-across see chapter 1 of the chemical safety report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- see below
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000) including the most recent partial revisions
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- The body weight of the animal was not determined after sacrifice.
Evaluation: Sufficient data was available to assess the possible irritation or corrosion potential of the test substance.
The study integrity was not adversely affected by the deviations.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
- EC Number:
- 271-756-9
- EC Name:
- Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides
- Cas Number:
- 68607-24-9
- IUPAC Name:
- 68607-24-9
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2215 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 ¿ 21.3
- Humidity (%): 45 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye remained untreated and served as the reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64.9 mg (volume of approx. 0.1ml) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 and 24 hours after instillation of the test substance
- Number of animals or in vitro replicates:
- 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 24 hours
- Irritant / corrosive response data:
- Instillation of approximately 65 mg of the test substance (a volume of approximately 0.1 mL) into an eye of one rabbit resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of opacity (maximum grade 2) and epithelial damage (100% of the corneal area). Iridial irritation grade 1 was observed and the irritation of the conjunctivae consisted of redness, chemosis and discharge.
Grey/white discoloration of the eyelids and nictating membrane (a sign of severe tissue damage) was noted. Erythema and oedema of the outside of the eyelids was noted.
Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 hours observation and the two further rabbits assigned to the study were not treated. - Other effects:
- Remnants of the test substance were present in the eye on Day 1.
No staining of (peri) ocular tissues by the test substance was observed.
No symptoms of systemic toxicity were observed in the animal until the animal was sacrficed due to severe ocular effects.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guideline-compliant acute eye irritation/corrosion study in rabbits, a supporting substance caused corneal opacity (maximum grade 2) with epithelial damage of 100% of the corneal area, iridial irritation grade 1, and irritation of the conjunctivae consisting of redness (grade 3), chemosis (grade 4) and discharge (grade 3) 24 hours after treatment. Signs of tissue damage of the eyelids and nictating membrane were observed as grey/white discoloration. Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons after 24 hours. The supporting substance caused irreversible effects on the rabbit eye.
- Executive summary:
An acute eye irritation/corrosion study with a supporting substance in the rabbit was carried out according to the following guidelines:
OECD No.405 (2002) "Acute Eye Irritation / Corrosion"
EC, Council Directive 67/548/EEC, An. V,B.5, (2004) "Acute Toxicity: Eye Irritation / Corrosion"
EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"
JMAFF guidelines (2000) including the most recent partial revisions.
A single sample of approximately 65 mg of supporting substance (a volume of approximately 0.1 ml) was instilled into an eye of one rabbit. Observations were made 1 and 24 hours after instillation. Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of opacity (maximum grade 2) and epithelial damage (100% of the corneal area). Iridial irritation grade 1 was observed and the irritation of the conjunctivae consisted of redness, chemosis and discharge. Grey/white discoloration of the eyelids and nictating membrane (a sign of severe tissue damage) was noted. Erythema and oedema of the outside of the eyelids was noted.
Based on the severity of the ocular lesions observed during the study, the animal was sacrificed for ethical reasons immediately after the 24 hours observation and the two further rabbits assigned to the study were not treated.
Remnants of the test substance were present in the eye on Day 1.
Based on the degree of the ocular injury and observed necrosis, it was concluded that ocular corrosion had occurred by instillation of the supporting substance into the rabbit eye.
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