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EC number: - | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- Reaction mass of N-[2-(2hydroxyethoxy) ethylacetamide and Glycerol
CAS number: 118974-46-2/56-81-5
Clear liquid, pale yellow to yellow
pH: 7.5-9.5 at 10% solution
Specific gravity / density: 1.15
Storage: RT in dark
Production date: 03/02/2018
Expiration date: 03/02/2019
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat
Strain: Crl: WI(Han)
Condition: Outbred, SPF-Quality
Source: Charles River Deutschland, Sulzfeld, Germany
Number of Animals: 3 females (nulliparous and non-pregnant).
Age at the Initiation of Dosing: Young adult animals (approximately 10-12 weeks old) were selected.
Weight at the Initiation of Dosing: 194 to 230 g.
following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles.
Target temperatures of 18 to 24°C with a relative target humidity of 40 to 70% were maintained. The actual daily mean temperature during the study period was 21°C with an actual daily mean relative humidity of 37 to 59% (see deviations in Appendix 3). A 12-hour light/12-hour dark cycle was maintained. Ten or greater air changes per hour with 100% fresh air (no air recirculation) were maintained in the animal rooms.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped.
- Area of exposure: 10% of the total body surface, i.e. approximately 18 cm² for females
- Type of wrap if used: The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test item using water.
- Time after start of exposure: 24 hours after application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg. The dose volume for each animal was based on the body weight measurement prior to dosing. Dose volume (mL/kg body weight) was calculated as follows: Dose level (g/kg) / spec.gravity or density (g/mL).
- Concentration (if solution): pure, no vehicle
- Constant volume or concentration used: Only one dose group of 2000 mg/kg bw
No vehicle; test item administered as received. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: twice daily; Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Body weight on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: local effects and irritation, clinical signs, body weight, and examination for internal macroscopic abnormalities.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LDLo
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- No toxicity, and no irritation; Only observed effects include chromodacryorrhoea (snout) noted for two animals on Day 1 only.
- Mortality:
- No mortality
- Clinical signs:
- Chromodacryorrhoea (snout) was noted for two animals on Day 1.
- Body weight:
- No effects
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- No irritation was noted for any of the animals at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value in Wistar Han rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
The objective of this study was to determine the potential toxicity of Reaction mass of N-[2 -(2hydroxyethoxy) ethylacetamide and Glycerol, when given by a single dermal dose.
The study was carried out based on the guidelines described in OECD No. 402 (2017) "Acute Dermal Toxicity"
Initially, Reaction mass of N-[2-(2hydroxyethoxy) ethylacetamide and Glycerol was administered to a single female Wistar Han rat by a single dermal application at 2000 mg/kg body weight for 24 hours in a range finder study. Based on the results, the main study was performed by dosing two additional females at 2000 mg/kg. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). Results for the main study include the results for the animal dosed at 2000 mg/kg in the range finder study.
Results: No mortality occurred. No irritation was noted for any of the animals at any time point. Chromodacryorrhoea (snout) was noted for two animals on Day 1. The body weight gain shown by the animals during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.
The dermal LD50 value of Reaction mass of N-[2-(2hydroxyethoxy) ethylacetamide and Glycerol in Wistar Han rats was established to exceed 2000 mg/kg body weight.
Based on these results, Reaction mass of N-[2-(2hydroxyethoxy) ethylacetamide and Glycerol does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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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