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EC number: 853-587-8 | CAS number: 199387-97-8
- 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
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study conducted according to OECD TG 423, the LD50 cut-off in rats was determined to be 5000 mg/kg bw (unclassified).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2022-05-02 to 2022-09-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: LFND3B1003
- Purity: 100% (HPLC)
- Expiry Date: August 2025
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: store in a cool place, protected from light and moisture
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Test item was dissolved in corn oil. The dose formulations were made shortly before each dosing occasion. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared solution thoroughly before each dose administration. - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: step 1: 8–9 weeks; step 2: 9–10 weeks; step 3: 8-9 weeks
- Weight at study initiation: step 1: 158–163 g; step 2: 173–177 g; step 3: 174–185 g
- Fasting period before study: 17 to 18 hours (access to water was permitted)
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: step 1: 7 days; step 2: 14 days; step 3: 7 days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: This vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): lot no. MKCP9878
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected to be 300 mg/kg body weight, as recommended in the OECD TG 423. - Doses:
- Step 1: 300 mg/kg bw
Step 2: 2000 mg/kg bw
Step 3: 2000 mg/kg bw - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Necropsy of survivors performed: yes; all animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
- Clinical signs including body weight: Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- The test item showed no mortality and no acute oral toxicity characteristics after a single dose administration at a dosage of 300 mg/kg bw and 2000 mg/kg bw.
- Clinical signs:
- other:
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
- Other findings:
- None of the animals showed weight loss during the observation period. The body weight development of all animals was within the expected range.
For individual results see box "Any other information on results incl. tables". - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, no signs of toxicity or mortality were observed and the median lethal dose of N-[2-(bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)Glycine after a single oral administration to female rats, observed over a period of 14 days is unclassified (LD50 cut-off = 5000 mg/kg bw).
- Executive summary:
In an acute oral toxicity study according to OECD 423, fasted young female Wistar rats/group were given a single dose N-[2-(bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)Glycine (100% purity) dissolved in corn oil. One group of three female rats was treated with the test item by oral gavage administration at a starting dosage of 300 mg/kg body at a dose volume of 10 mL/kg. No compound related mortality was recorded for any animals of this step. Based on these results and according to the acute toxic class method regime, two groups, each of three female rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. No compound related mortality was recorded for any animal of step 2 and 3.
All animals survived until the end of the study. No clinical findings were observed in any of the animals. None of the animals showed weight loss during the observation period. No specific gross pathological changes were recorded for any animal.
In this study, a LD50 cut-off = 5000 mg/kg bw (unclassified) was determined.
Reference
Table 1: Absolute Body Weights in g and Body Weight Change in %
Step | Animal No./Sex | Starting Dose (mg/kg bw) | Body Weight (g) | Body Weight Change in Comparison to Day 1 [%] | ||
Day 1 | Day 8 | Day 15 | ||||
1 | 1/Female | 300 | 163 | 188 | 200 | 23 |
2/Female | 158 | 176 | 190 | 20 | ||
3/Female | 160 | 191 | 204 | 28 | ||
2 | 4/Female | 2000 | 177 | 202 | 215 | 21 |
5/Female | 177 | 197 | 208 | 18 | ||
6/Female | 173 | 202 | 214 | 24 | ||
3 | 7/Female | 2000 | 174 | 196 | 214 | 23 |
8/Female | 185 | 222 | 230 | 24 | ||
9/Female | 176 | 202 | 207 | 18 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- GLP guideline study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute oral toxicity study with the test item N-[2-(bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)Glycine in fasted young female Wistar rats according to OECD 423, no compound related mortality, clinical findings, body weight effects or pathological signs was recorded at doses of 300 and 2000 mg/kg bw/day.
Based on this study, a LD50 cut-off = 5000 mg/kg bw (unclassified) was determined.
Justification for classification or non-classification
Based on the available study results, classification of N-[2-[bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)glycine for acute toxicity is not warranted in accordance with CLP Regulation (EC) No 1272/2008.
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