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EC number: 946-010-7 | 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 toxicity studies with Alkaterge E are available for the oral and dermal route. The acute oral LD50 of Alkaterge E is greater than 2,000 mg/kg of body weight in female rats. The dermal LD50 value of Alkaterge E in Wistar rats (both sexes) was established to exceed 2000 mg/kg body weight.
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:
- January - March, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Housing: The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 2011). Litter paper was placed beneath the cage and was changed at least three times per week.
- Animal Room Temperature and Relative Humidity Ranges: 19-23ºC and 30-45%, respectively.
- Animal Room Air Changes/Hour: 12. Airflow measurements are evaluated regularly and the records are kept on file at Eurofins PSL.
- Photoperiod: 12-hour light/dark cycle
- Acclimation Period: 9-28 days
- Feed: Purina Certified Rodent Diet (PMI #5002)
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analysis of the water is conducted regularly and the records are kept on file at Eurofins PSL. The most recent water analysis was conducted in December 2010. Purina Certified Rodent Diet, PMI #5002, Lot Numbers: SEP 23 10 3A, OCT 28 10 1A and NOV 10 10 3A, were analyzed in October and November, 2010.
- Cage: Each cage was identified with a cage card indicating at least the study number, dose level, identification and sex of the animal.
- Animal: A number was allocated to each rat on receipt and a stainless steel ear tag bearing this number was attached to the rat. This number, together with a sequential - Route of administration:
- oral: gavage
- Details on oral exposure:
- Following acclimation, experimentally naive rats were fasted overnight by removing the feed from their cages. During the fasting period, the rats were examined for health and weighed (initial). Five healthy naive female rats (not previously tested) were selected for test.
The test substance was administered to the stomach using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. Following each administration, each animal was returned to its designated cage. Feed was replaced immediately after dosing. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived test substance administration.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period
- Other findings:
- Following administration, two rats exhibited ano-genital staining and/or reduced fecal volume, but both animals recovered from these symptoms by Day 4 and, along with the other three animals, appeared active and healthy for the remainder of the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 of ALKATERGETM- E Oxazoline is greater than 2,000 mg/kg of body weight in female rats.
- Executive summary:
An acute oral toxicity test (Up and Down Procedure) was conducted with Fischer 344 rats to determine the potential for ALKATERGE TM- E Oxazoline to produce toxicity from a single dose via the oral route. An initial limit dose of 2,000 mg/kg was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females received the same dose level, sequentially. Since these animals survived, no additional animals were tested. Females were selected for the test because they are frequently more sensitive to the toxicity of test compounds than males. All animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily for up to 14 days after dosing. Body weights were recorded prior to administration and again on Days 7 and 14 (termination) following dosing. Necropsies were performed on all animals at terminal sacrifice.All animals survived test substance administration and gained body weight during the study. Following administration, two rats exhibited ano-genital staining and/or reduced fecal volume, but both animals recovered from these symptoms by Day 4 and, along with the other three animals, appeared active and healthy for the remainder of the observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Under the conditions of this study, the acute oral LD50 of ALKATERGE TM- E Oxazoline is greater than 2,000 mg/kg of body weight in female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Identification: Alkaterge E
Appearance: Brown viscous liquid
Batch: D598F47BC1
Purity/Composition: UVCB
Test item storage: At room temperature
Stable under storage conditions until: 05 April 2020 (retest date)
Additional information
Test Facility test item number: 208794/A
Purity/Composition correction factor: No correction factor required
Chemical name (IUPAC, synonym or trade name: 4-Ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol,Alkaterge E
CAS number: 68140-98-7
Molecular formula: C23H43NO2
Molecular weight: 365.60
Specific gravity / density: 0.925 (25°C) - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing
On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and 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. These housing conditions were maintained unless deemed inappropriate by the Study Director and/or Clinical Veterinarian. The room(s) in which the animals were kept were documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled.
Environmental Conditions
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 to 22°C an actual daily mean relative humidity of 49 to 72% (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.
Food
Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures. The feed was analyzed by the supplier for nutritional components and environmental contaminants.
Water
Municipal tap-water was freely available to each animal via water bottles. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Alkaterge E, was administered as received. Adjustment was made for specific gravity of the test item. No correction was made for the purity/composition of the test item.
A single dose of test item was administered to the appropriate animals by dermal application on Day 1. One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total body surface, i.e. approximately 25 cm² for males and 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only. The application period was 24 hours, after which the dressing was removed and the skin cleaned of residual test item using water or an appropriate vehicle. - Duration of exposure:
- 24 hours
- Doses:
- 2000 m/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- not required
- Details on study design:
- Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day. Animals were not removed from cage during observation, unless necessary for identification or confirmation of possible findings.
Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. The observation period was 14 days. All the animals were examined for reaction to dosing. The onset, intensity and duration of these signs was recorded (if appropriate), particular attention being paid to the animals during and for the first hour after dosing.
Animals were weighed individually on Day 1 (pre-dose), 8 and 15.
All animals were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture, quick breathing, chromodaccryorrhoea (snout) and/or piloerection were noted for the animals between Days 1 and 6. Scabs (back and left flank) and/or focal erythema (back and left flank) were noted for the animals between Days 2 and 11. G
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 value of Alkaterge E in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
Alkaterge E was administered to five Wistar rats of each sex by a single dermal application at 5000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. Hunched posture, quick breathing, chromodaccryorrhoea (snout) and/or piloerection were noted for the animals between Days 1 and 6. Scabs (back and left flank) and/or focal erythema (back and left flank) were noted for the animals between Days 2 and 11. General erythema, scales, scabs, thickened area and brown discoloration were seen in the treated skin-area of the animals during the observation period. These local effects were considered not to have affected the conclusion of the study. The body weight gain 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 Alkaterge E in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, Alkaterge E 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 (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
The available data on acute toxicity of the test substance do not meet the criteria for classification according to the CLP/GHS Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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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