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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to the appropriate OECD TG and GLP. No sufficient information, including purity data is available for the test material and test animals as well as environmental conditions during the treatment period. Moreover, not all blood and clinical chemistry parameters as well as organ weights were determined. The number of control and treated animals is not available; only one dose was administered to the rats.
Data source
Reference
- Reference Type:
- publication
- Title:
- Stable aqueous solutions of antibiotics of the tetracycline group with improved tissue tolerance
- Author:
- Neumann, H., Viehmann, P.
- Year:
- 1 959
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The animals were administered with the test material at a single dose for 5 days/week. Moreover, only limited blood and clinical chemistry parameters as well as organ weights were determined. The number of control and treated animals is not available; only one dose was administered to the rats.
- GLP compliance:
- no
- Limit test:
- 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
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 90 - 120 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 450 mg/mL
- Amount of vehicle: 2 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- once daily, 5 days/week
Doses / concentrations
- Dose / conc.:
- 900 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- No data
- Control animals:
- yes
- Details on study design:
- No data
- Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Body weight of the animals was recorded weekly during the course of the study.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Haematology was performed 8 and 12 weeks post-administration.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters examined: Hemoglobin, total erythrocyte count, total leukocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Clinical chemistry was performed 8 and 12 weeks post-administration.
- Animals fasted: No data
- How many animals: No data
- Parameters examined: liver function via bromthalein test (quick test)
URINALYSIS: Yes
- Time schedule for collection of urine: Urinalysis was performed 8 and 12 weeks post-administration.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: total protein, glucose, urinary sediment
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes (lung, liver, kidney, spleen, epididymides, ovaries, bone marrow, heart chamber)
- Statistics:
- Mean values and standard deviations were calculated where necessary.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: No significant body weight gain could be recorded in the treatment group compared to the control group.
HAEMATOLOGY: There were no treatment-related changes identified in the haematological parameters measured.
CLINICAL CHEMISTRY: There were no treatment-related changes identified in the clinical parameters measured.
URINALYSIS: Urinalysis did not reveal changes in the investigated urine parameters.
HISTOPATHOLOGY: NON-NEOPLASTIC: No treatment-related histopathological changes were detected.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 900 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No systemic effects could be observed during the course of the study.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Body weight gain after termination of the study (12 weeks)
Dose group (mg/kg bw/day) |
Body weight gain (g) |
0 |
93 ± 6 |
900 |
83 ± 7 |
Table 2: Haematology parameters
Dose group (mg/kg bw/day) |
Hemoglobin (g%) |
Leukocyte count (1000/mm³) |
Erythrocyte count (10/mm³) |
Quick test (sec) |
0 |
14.6 ± 0.2 |
17.5 ± 1.6 |
7.8 ± 0.3 |
10.8 ± 0.3 |
900 |
15.3 ± 0.2 |
12.3 ± 0.9 |
8.3 ± 0.3 |
10.7 ± 0.3 |
Applicant's summary and conclusion
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.
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