Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 627-023-4 | CAS number: 2441-41-0
- 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-19 to 2008-06-02
- 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:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- LCA08002
- IUPAC Name:
- LCA08002
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): LCA08002
- Substance type: Lipoaminoacid
- Physical state: White powder
- Analytical purity: 100%
- Lot/batch No.: 1549 JG
- Expiration date of the lot/batch: 2009-04-10
- Storage condition of test material: Room temperature
Constituent 1
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: 13 to 14 weeks old
- Weight at study initiation: 2.91 kg to 3.20 kg
- Housing: Individual box
- Diet (e.g. ad libitum): SDS-C15 supplied freely
- Water (e.g. ad libitum): tap-water from public distribution system-supplied freely
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C to 22°C
- Humidity (%): 30% to 50%
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12h hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g as supplied
- Duration of treatment / exposure:
- 1 instillation without physical removal
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1g of the test item was instilled, as supplied, into the conjuctival sac of one eye. The other eye remained untreated as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D4, two additional animals were treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- conjonctivae, iris and cornea
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 16.3
- Max. score:
- 16.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been slight to moderate, and totaly reversible in the three animals:
- at the conjonctivae level; a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between D4 and D7, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D2 and D5;
- at the corneal level: a slight opacity, registered 1 hour after the test item instillation in two animals,
- at the iris level: a congestion noted 1 hour after the test item instillation in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Journal Officiel de la République Française dated July 10th, 1992
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item LCA08002:
- Is Moderately irritant for eye (Max. O.I = 16.3) 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. Directives n°67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globaly Harmonized System (COM(2007)355 final), the test item must not be classified in category 2. No signal and hazard statement are required. - Executive summary:
The test item LCA08002 was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1g. The experimental protocol was established on the basis of the official method as defined in the OECD 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 slight to moderate, and totaly reversible in the three animals:.
- at the conjonctivae level; a slight to moderate redness, noted 1 hour after the test item instillation and totally reversible between D4 and D7, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D2 and D5;
- at the corneal level: a slight opacity, registered 1 hour after the test item instillation in two animals,
- at the iris level: a congestion noted 1 hour after the test item instillation in one animal.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCA08002 must not be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives n°67/548, 2001/59 and 99/45. No symbol and risk phrase are required..
In accordance with the Globaly Harmonized System (COM(2007)355 final), the test item must not be classified in category 2. No signal word and hazard statement are required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.