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EC number: 238-122-3 | CAS number: 14246-53-8
- 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:
- 06-13 august 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: complete study according OECD 405 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- N-(1-oxooctyl)glycine
- EC Number:
- 238-122-3
- EC Name:
- N-(1-oxooctyl)glycine
- Cas Number:
- 14246-53-8
- Molecular formula:
- C10H19NO3
- IUPAC Name:
- N-(1-oxooctyl)glycine
- Reference substance name:
- LCA07012
- IUPAC Name:
- LCA07012
- Details on test material:
- Sponsor’s identification: LCA07012
• Date received : 24 & 27 July 2007
• Container : plastic flask (n=3)
• Form : powder
• Quantity : 726.0 g (container + contents)
• Colour : white
• Batch n° : 0716300006
• Storage : room temperature
• Production date: 12 June 2007
• Expiry date: 11 June 2010 (re-test)
• Purity: 99%
It was identified under the code number: PH-07/0301.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand Red
- Details on test animals or tissues and environmental conditions:
- One female albino New Zealand rabbit was supplied by the Elevage de Gérome (Quartier Labaste –
F40260 Linxe). It was kept during a minimal 5-day acclimatisation period. During the test, the animal
weighed between 2.48 kg and 2.54 kg.
The 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 41% and 72%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained
untreated serving as control. - Duration of treatment / exposure:
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following
treatment, - Observation period (in vivo):
- until 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1 g of the test item was instilled 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, two additional animals were not 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 in page 8.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 24h
- Remarks on result:
- other: moderate redness a
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritant / corrosive response data:
- 0.1g/eye:
- moderate conjunctival redness from 24 hr, partially reversed by day 7,
- moderate chemosis from 1 hr, reversed by day 7,
- moderate corneal opacity from 1 hr and corneal ulceration from day 4, neither reversed by day 7,
- iridial congestion from days 1 to 3,
- whitish secretion on days 1 and 2. - Other effects:
- none
Any other information on results incl. tables
The ocular reactions observed during the study have been moderate and partially reversible. Taking into account the reaction registered (corneal ulceration), the test was stopped at D7, in accordance with the principles of animal welfare.
It was noted:
- at the conjunctivae level: a moderate redness, 24 hours after the test item instillation and partially reversible at the end of the observation (D7) associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible at D7,
- at the corneal level: a moderate opacity, registered 1 hour after the test item instillation and still registered at the end of the observation time,
- at the iris level: a congestion noted between D1 and D3. It was noted a corneal ulceration, from the 5th day of the test. This lesion persisted for 72 hours. Furthermore, it was noted a whitish secretion requiring a rinse with isotonic sodium chloride, at D1 and D2.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item
LCA07012:
- is irritant for the eye (Max. O.I = 49) according to the classification established in the Journal
Officiel de la République Française dated July 10th, 1992.
- and, must be classified R41 "Risk of serious damage to eyes" taking into account the reaction
registered (corneal ulceration), 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. It
must be characterised by the symbol “Xi” and the danger label “irritant”. - Executive summary:
The test item LCA07012 was instilled, into the eye of one New Zealand rabbit at the dose of 0.1 g. 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 partially reversible. Taking into account the reaction registered (corneal ulceration), the test was stopped at D7, in accordance with the principles of animal welfare. It was noted: - at the conjunctivae level: a moderate redness, 24 hours after the test item instillation and partially reversible at the end of the observation (D7) associated with a moderate chemosis, noted 1 hour after the test item instillation and totally reversible at D7, - at the corneal level: a moderate opacity, registered 1 hour after the test item instillation and still registered at the end of the observation time, - at the iris level: a congestion noted between D1 and D3. It was noted a corneal ulceration, from the 5th day of the test. This lesion persisted for 72 hours. Furthermore, it was noted a whitish secretion requiring a rinse with isotonic sodium chloride, at D1 and D2. In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item LCA07012 must be classified R41 "Risk of serious damage to eyes" taking into account the reaction registered (corneal ulceration), 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. It must be characterised by the symbol “Xi” and the danger label “irritant”.
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