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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2007 - 21 January 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): LCA07012
- Substance type: mono-constituent
- Physical state: white powder
- Purity: not indicated
- Impurities (identity and concentrations): not indicated
- Purity test date: not indicated
- Lot/batch No.: 0715800012
- Expiration date of the lot/batch: 6 June 2010
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature, protected from sunlight and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder
- Age at first treatment: approx. 10 weeks
- Weight at first treatment (mean): M=403 g, F=257 g
- Housing: individually, except during pairing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Relative humidity: 50 ± 20%
- Light/dark cycle: 12h/12h
- Ventilation: 12 cycles/hour of filtered, non-recycled air.
IN-LIFE DATES: beginning: 27 November 2007 / end: up to 21 January 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
test item was ground, mixed with vehicle heated to 45°C, forming a solution.
The test item dosage forms were prepared at up to 11-day intervals
VEHICLE
- Justification for use and choice of vehicle (if other than water): not indicated
- Concentration in vehicle: 5, 15 and 40 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg/day
- Lot/batch no. (if required): S 35142-236, S 35142-017 and S 39776-337
- Purity: not indicated - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Data awaited from study director
- Duration of treatment / exposure:
- from 2 weeks before mating until the end of mating (males: total of 37-38 days) or day 5 pp (females: total of 42-55 days)
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 75, 200 mg/kg/day (m/f)
Basis:
other: Nominal per gavage
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: in a previous 14-day toxicity study in the rat (see 7.5.1) mortality occured at 1000 mg/kg/day and moderate toxicity (limited to clinical signs and weight gain) occured at 300 mg/kg/day.
- Rationale for animal assignment: computerized stratification procedure (average body weight of each group is similar)
- Satellite and post-exposure recovery period: not performed. - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule: day 1 and then weekly; and in F also days 0, 7, 14 and 20 post-coitum and days 1 and 5 post-partum
FOOD CONSUMPTION for each animal: Yes
- Time schedule: weekly (last 7-day consumption period)
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on the day of sacrifice
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: 5M+5F
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on the day of sacrifice
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: 5M+5F
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule: at the end of the treatment period for M, on day 5 post-partum for F
- Dose groups that were examined: all
- Battery of functions tested: behavior / reflexes / sensory activity / grip strength / motor activity / rectal temperature - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, adults and pups of all groups
ORGAN WEIGHTS: Yes, adults of all groups
HISTOPATHOLOGY: Yes, adults in control and high-dose
all : see Table 1
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Loud breathing was observed at all dose-levels but no microscopic abnormalities were found in the respiratory organs of the 200 mg/kg/day animals therefore it was considered that this clinical observation did not induce long-term effects. There were no unscheduled deaths at any dose-level.
BODY WEIGHT GAIN:
A minimally lower mean body weight gain during the first 2 weeks of treatment of the males treated at 200 mg/kg/day, with recovery during the second 2 weeks of treatment.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL = highest tested dose, without relevant effects.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Based on the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 200 mg/kg/day.
- Executive summary:
The test item, LCA07012, was administered daily by oral gavage to male and female Sprague-Dawley rats, for 2 weeks before mating, during mating, gestation and until day 5 post-partum, at dose-levels of 25, 75 or 200 mg/kg/day.
Loud breathing was observed at all dose-levels but no microscopic abnormalities were found in the respiratory organs of the 200 mg/kg/day animals therefore it was considered that this clinical observation did not induce long-term effects. Males treated at 200 mg/kg/day gained minimally less weight during the first 2 weeks of treatment but some of this was recuped during the second 2 weeks and was therefore considered not to represent an effect of treatment. No histopathological lesions considered to be reflective of systemic toxicity were observed.
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