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EC number: 942-725-3 | CAS number: -
- 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:
- 2008-06-09 to 2008-06-25
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- Acylation product between cocoyl chloride and aminoacids
- EC Number:
- 918-984-3
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Acylation product between cocoyl chloride and aminoacids
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): LCE08086
- Substance type: Lipoamino acid
- Physical state: liquid
- Analytical purity: 31% dry matter
- Purity test date: 2008-03-29
- Lot/batch No.: 0807000020
- Retest date of the lot/batch: 2011/03/10
- Stability under test conditions: stable
- Storage condition of test material: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste– F40260 Linxe)
- Age at study initiation: 12 to 13 weeks
- Weight during the test: 2.53 kg and 3.22 kg
- Housing:
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 39% and 63%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
- Diet (e.g. ad libitum): supplied freely (foodstuff (SDS- C15)
- Water (e.g. ad libitum): supplied freely (tap-water from public distribution system)
- Acclimation period: minimal 5-day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of the test item was instilled, as supplied
- Duration of treatment / exposure:
- 9 days
- Observation period (in vivo):
- 1hour, 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- Three female
- Details on study design:
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, according to the numerical evaluation given below.
NOTE :
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 D4 to D21 in order to determine the reversible character of the lesions observed.
EVALUATION OF OCULAR IRRITATION
Eye examinations are carried out using the scale of lesion scores in the following order:
CHEMOSIS (A)
• No swelling ................................................................................................................................... 0
• Slight swelling, including the nictitating membrane................................................................1
• Swelling with eversion of the eyelid ...........................................................................................2
• Swelling with eyelid half-closed ................................................................................................. 3
• Swelling with eyelid more than half-closed .............................................................................. 4
DISCHARGE (B)
• No discharge ................................................................................................................................. 0
• Slight discharge (normal slight secretions in the inner corner not to be
taken into account) .......................................................................................................................... 1
• Discharge with moistening of the eyelids and neighbouring hairs....................................... 2
• Discharge with moistening of the eyelids and large areas around the eye ......................... 3
REDNESS (C)
• Blood vessels normal .................................................................................................................... 0
• Vessels significantly more prominent than normal ................................................................. 1
• Vessels individually distinguishable with difficulty
- Generalised red coloration........................................................................................................... 2
- Generalised deep red coloration ................................................................................................ 3
IRIS (D)
• Normal ............................................................................................................................................ 0
• Iris significantly more wrinkled than normal, congestion,
swelling of the iris which continues to react to light, even slowly............................................. 1
• No reaction to light, haemorrhage, significant damage
(any or all of these characteristics)................................................................................................ 2
CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no loss of glint or polish) .................................................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .................................. 1
• Easily identifiable translucent area, iris details slightly obscured............................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable ...................... 3
• Total corneal opacity, completely obscuring the iris and pupil................................................. 4
CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less.............................................................. 1
• Between one quarter and half........................................................................................................... 2
• Between half and three quarters ..................................................................................................... 3
• Between three quarters and the entire surface.............................................................................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate, and totally reversible in the three
animals:
- at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally
reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item
instillation and totally reversible between D3 and D4;
- at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally
reversible between D3 and D7.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item LCE08086:
- is moderately irritant for the eye (Max. O.I = 28) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required. - Executive summary:
The test item LCE08086 was instilled as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC. The ocular reactions observed during the study have been moderate, and totally reversible in the three animals: - at the conjunctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D7 and D9, associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D3 and D4; - at the corneal level: a moderate opacity, registered 24 hours after the test item instillation and totally reversible between D3 and D7. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCE08086 must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required
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