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EC number: 419-240-6 | CAS number: 171054-89-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.05.1995 - 19.05.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- evaluation of eye response refering to Draize's method: 1959
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-240-6
- EC Name:
- -
- Cas Number:
- 171054-89-0
- Molecular formula:
- Hill formula: C28H37NO7 CAS formula: (C11H12O3)2.C6H13NO
- IUPAC Name:
- bis(4-(4-methylphenyl)-4-oxobutanoic acid); 4-ethylmorpholine
- Test material form:
- solid: crystalline
- Details on test material:
- Substance quality: >97%
Batch No.: E- 007K107SLL
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- One New Zealand White rabbit supplied by David Percival Ltd., Moston, Sandbach, Cheshire, UK, was used. At the start of the study the animal weighed 3.08 kg and was approximately twelve to six weeks old. After a minimum acclimatisation period of five days the animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animal was housed in a suspended metal cage. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 17 to 20 °C and relative humidity of 49 to 58%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continous light and 12 hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- about 1 s
- Observation period (in vivo):
- 1 h, 24 h, 48 h
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbit was examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope.
A volume of 0.1 mL of the test material, which was found to weigh approximately 17 mg (as measured by gently compacting the required volume into an adapted syringe) was placed 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 application, to prevent loss of the test material, and then released. The left eye remained and was used for control purposes. Immediately after administration of the test material, an assassment of the initial pain reaction was made.
Assessment of ocular damage/irritation was made approximately 1, 24 and 48 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Acedemy of Sciences, Washington D.C. p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 40
- Max. score:
- 80
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 40
- Max. score:
- 80
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 40
- Max. score:
- 80
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- other: discharge score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- other: discharge score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- other: discharge score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 6
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 59
- Max. score:
- 110
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 57
- Max. score:
- 110
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 59
- Max. score:
- 110
- Reversibility:
- other: On humane grounds the study was determined prematurely after the 48 hour observation time due to the severity of the eye irritation.
- Irritant / corrosive response data:
- Areas of translucent corneal opacity were noted in the treated eye one hour after treatment and at the 24 and 48-hour observations. Sloughing of the cornea was noted in the treated eye one hour after treatment.
- Other effects:
- Sloughing of the cornea and lower conjunctival membrane
together with pale green discolouration of the nictitating
membrane was observed.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-hour observations.
Pale green discolouration of the nicitating membrane was noted in the treated eye one hour after treatment. Sloughing of the lower conjunctival membrane was noted in the treated eye at the 48-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material produced a maximum score of 59.0 and was classified as at least a severe irritant (Class 6 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material was also considered to be irritant according to EU labelling regulations. It is reasonable to assume that the symbol "Xi", the indication of danger "irritant" and the highest risk phrase R41 "RIKS OF SERIOUS DAMAGE TO EYES" 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 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Comission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
A single application of the test material to the non-irrigated eye of one rabbit produced areas of translucent corneal opacity, iridial inflammation and moderate conjunctival irritation. Other ocular effects noted were sloughing of the cornea and lower conjunctival membrane and pale green discolouration of the nicitating membrane. The animal was killed for humane reasons immediately after the 48-hour observation in accordance with current UK Home Office guidelines. No further animals were treated.
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