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EC number: 700-012-2 | CAS number: 950919-28-5
- 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:
- From February 09 to 19, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 24th April 2002
- Deviations:
- no
- Remarks:
- Only two animals were tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- Only two animals were tested
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on August 19, 2008/ signed on March 04, 2009)
Test material
- Reference substance name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- EC Number:
- 700-012-2
- Cas Number:
- 950919-28-5
- Molecular formula:
- C12H14O3
- IUPAC Name:
- 7-(propan-2-yl)-3,4-dihydro-2H-1,5-benzodioxepin-3-one
- Test material form:
- solid
- Remarks:
- paste / solid block
- Details on test material:
- - Physical state: solid, pale yellow to yellow block, or pasty
- Stability under test conditions: no data
- Storage condition of test material: in the dark, preferably at about 4-10°C and under nitrogen.
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 Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.71-2.90 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK), ad libitum.
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: February 09, 2009 To: February 19, 2009.
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 (approximately 0.73 mg)
- For the purpose of the study, the test material was ground to a fine powder prior to application. - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation of test material
- Number of animals or in vitro replicates:
- 2 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.
TOOL USED TO ASSESS SCORE: 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:
- cornea opacity score
- Basis:
- animal: #1 and #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 and #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- other: Mean 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- - No corneal or iridial effects were observed during the study.
- Moderate conjunctival irritation was observed in all treated eyes at 1 and 24 h after treatment and minimal conjunctival irritation was observed at the 48 h.
- All treated eyes appeared normal at the 72 h observation. - Other effects:
- - All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
2 / 2 |
2 / 2 |
24 h |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
1 / 1 |
1 / 1 |
48 h |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
72 h |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Average 24, 48 and 72 h |
0.0 |
0.0 |
0.0 |
1.0 / 1.0 |
0.3 / 0.3 |
0.3 / 0.3 |
Reversibility |
- |
- |
- |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
- |
- |
- |
72 h |
48 h |
48 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material (approximately 0.73 mg) was instilled into the right eye of 2 male New Zealand White rabbits following a sequential testing strategy. The left eye remained untreated and served as control. 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 eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.
No corneal or iridial effects were observed during the study. Moderate conjunctival irritation was observed in all treated eyes at 1 and 24 h after treatment and minimal conjunctival irritation was observed at the 48 h. All treated eyes appeared normal at the 72 h observation.
Mean individual scores at 24, 48 and 72 h after exposure for the 2 animals were 0.0 / 0.0 for cornea score; 0.0 / 0.0 for iris score; 1.0 / 1.0 for conjunctivae score and 0.3 / 0.3 for chemosis score.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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