Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-349-8 | CAS number: -
- 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
Acute oral toxicity
OECD 420 (2018) - In an acute oral toxicity study (OECD 423), groups of fasted, 8-9 week old, female Wistar (RccHan™:WIST) rats were given a single oral dose of N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
at doses 2000 and 300 mg/kg bw and observed for 14 days.
Oral LD50 female rats = 2000 mg/kg bw.
According to the UN GHS classification, the test item does not meet the criteria for acute oral toxicity.
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:
- 12 July 2017 - 15 February 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: n/a
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: n/a
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: applied undiluted
- Final preparation of a solid: n/a
FORM AS APPLIED IN THE TEST (if different from that of starting material): applied as supplied
OTHER SPECIFICS: n/a - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: body weight variation did not exceed ±20% of the mean body weight at the start of treatment
- Fasting period before study: yes
- Housing: housed in groups of up to 4 individuals in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): free access to food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK)
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- The test item was ground to a fine powder using a mortar and pestle and freshly prepared, as required, as a suspension in 5% Carboxymethylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5% Carboxymethylcellulose
- Amount of vehicle (if gavage): 5%
- Justification for choice of vehicle: the most suitable vehicle
- Lot/batch no. (if required): not specified
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: maximum guideline required concentration - 2000 mg/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Each animal was givena single dose of 10 mL/kg dose volume of 2000 mg/kg of the test item of 200 mg/mL concentration.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 1, 2 and 4 hours after dosing then daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- not required
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths reported
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System Unclassified).
- Executive summary:
OECD 420 (2018) - In an acute oral toxicity study, a group of fasted, 8-12 week old female Wistar rats were given a single oral dose of
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days.In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw.
In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.
In conclusion, the test item,
N-(2-{[C16-18 (even numbered) alkanoyl]amino}ethyl)-N-(2-hydroxyethyl)[C16-18 (even numbered) alkylamide
did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.
Reference
Table 2: Number of animals dead (and with evident toxicity)
Dose (mg/kg bw) |
Mortality (# dead / total) |
Time range of deaths (hours) |
Number with evident toxicity (# / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
- |
0 / 5 |
0 / 5 |
n/a |
- |
0 / 5 |
0 / 5 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2,000 mg/kg.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.5.2, Column 2 of REACH, testing by the inhalation route does not need to be conducted if:
If exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The acute inhalation toxicity study was waived in accordance with Annex VIII, Section 8.5.2
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII, Section 8.5.3, Column 2 of REACH, testing by the dermal route does not need to be conducted if:
- the substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route and
- no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
For this substance, no systemic effects were observed in the in vivo acute oral toxicity study (OECD 420), or in the LLNA study (OECD 429) where 10 % (w/w) solution was tested at the highest dose level.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The acute dermal toxicity study was waived in accordance with Annex VIII, Section 8.5.3, Column 2.
Additional information
OECD 420 (2018) - In an acute oral toxicity study, a group of fasted, 8-12 week old female Wistar rats were given a single oral dose of the test item at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days. In the absence of mortality during the observation period, the oral LD50 was estimated to be greater than 2000 mg/kg bw. In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.
Justification for classification or non-classification
Oral LD50 females rat reported at 2000 mg/kg bw, according to the UN GHS classification, the test item does not meet the criteria for acute oral toxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.