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EC number: 226-546-1 | CAS number: 5422-34-4
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted similar to a appropriate OECD test guideline and in compliance with GLP. Only limited information on the test material is available. No analytical purity of the test substance is given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2 Oct 2012
- Deviations:
- yes
- Remarks:
- Relative humidity/temperature exceeded guideline specific standard values. Occular observations were only performed for 3 days.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-2-hydroxyethyllactamide
- EC Number:
- 226-546-1
- EC Name:
- N-2-hydroxyethyllactamide
- Cas Number:
- 5422-34-4
- Molecular formula:
- C5H11NO3
- IUPAC Name:
- N-2-hydroxyethyllactamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: in grid-bottomed metal cages
- Diet: antibiotic-free pelleted rabbit diet, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14 - 22
- Humidity (%): 71 - 90
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 24, 48 and 72 h - Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: binocular loupe / slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Instillation of 0.1 mL of N-2-hydroxyethyllactamide into one eye of each of six rabbits resulted in effects of slight conjunctival redness (grade 1) 24 hours post-application of the test material. This response was maintained by one animal 48 h post-application but had disappeared within 72 h. The average conjunctivae score was calculated to be 0.22. No eye irritating effects were recorded for corneal opacity, iridial effects and chemosis. Therefore, the mean values were 0.0. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Individual eye irritation values
Rabbit no. |
Time [h] |
Conjunctivae Redness Swelling |
Iris |
Cornea |
|
1 |
24 48 72 average |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
2 |
24 48 72 average |
1 0 0 0.33 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
3 |
24 48 72 average |
1 0 0 0.33 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
4 |
24 48 72 average |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
5 |
24 48 72 average |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
6 |
24 48 72 average |
1 1 0 0.67 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Table 2: Mean eye irritation values
Time [h] |
Conjunctivae Redness Swelling |
Iris |
Cornea |
|
24 48 72 average |
0.5 0.17 0 0.22 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
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