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EC number: 217-440-6 | CAS number: 1852-04-6
- 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 21 January 2013 to 04 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A well documented GLP study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Undecanedioic acid
- EC Number:
- 217-440-6
- EC Name:
- Undecanedioic acid
- Cas Number:
- 1852-04-6
- Molecular formula:
- C11H20O4
- IUPAC Name:
- undecanedioic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): UNDECANEDIOIC ACID
- Physical state: white powder
- Analytical purity: 97.0 %
- Purity test date: 2012-05-09
- Lot/batch No.: 1112050079
- Expiration date of the lot/batch: 07 June 2015
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino New Zealand rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: the Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: 13-14 weeks old
- Weight: between 2.17 kg and 3.13 kg
- Housing: the animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Diet: foodstuff (SAFE – 112)
- Water: tap-water from public distribution system
- Acclimation period: minimal 5-day acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Humidity: 30 to 70 %
- Air changes: between 10 and 15 changes per hour
- Photoperiod: the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated serving as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3 animals.
Initially, a single animal was treated. After consideration of the responses produced on day 7 in the first animal, two additional animals were treated. - Details on study design:
- 0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.
Remaining test item requiring physiological rinse was noted, one hour after the test item instillation, in two animals.
If no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D7 to D21 in order to determine the reversible character of the lesions observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Remarks:
- - lesion
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Remarks:
- - lesion
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Remarks:
- - lesion
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate to important and totally reversible:
- at the conjunctivae level: a moderate to important redness noted 1 hour after the test item instillation and totally reversible on day 7, associated with a moderate to important chemosis noted 1 hour after the test item instillation totally reversible on day 7.
- at the iris level: a congestion noted 1 hour after the test item instillation and totally reversible on day 3.
- at the corneal level: a moderate corneal opacity, noted 1 hour after the test item instillation and totally reversible on day 7.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLASSIFICATION in accordance with the CLP regulation
- Conclusions:
- In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item UNDECANEDIOIC ACID must be classified R36 “irritating to eyes”, according to the criteria for the Directive 67/548 and category 2 “Irritating to eyes”, H319 in accordance with the Regulation (EC) No. 1272/2008.
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