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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-553-6 | CAS number: 2461-15-6
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from July 19, 1983 to August 2, 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- [[(2-ethylhexyl)oxy]methyl]oxirane
- EC Number:
- 219-553-6
- EC Name:
- [[(2-ethylhexyl)oxy]methyl]oxirane
- Cas Number:
- 2461-15-6
- Molecular formula:
- C11H22O2
- IUPAC Name:
- 2-{[(2-ethylhexyl)oxy]methyl}oxirane
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rationale: The rat has been selected for this test as being a standard species for the determination of an acute oral LD50.
Species and Strain: Rat, Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 166 - 208 g
Initial Age: 7 - 8 weeks
Individual Identification: By colour code using picric acid
Husbandry: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin). The animal room was air conditioned: temperature 22 ±3 ° C, relative humidity was 55 ±15%, 12 hours light/day, approximately 15 air changes/h.
Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- Pre-treatment:
The animals were allocated to the different dose groups by random selection. Prior to dosing, the animals were fasted overnight.
Administration: oral, by gastric intubation (gavage)
Observation Period: 14 days or until all symptoms have disappeared, whichever lasts longer
Volume (ml/kg body weight) applied: 10 - Doses:
- 5000, 1000 mg/kg bw.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- Dose Levels : 5000/ 1000 mg/kg bw.
Numher of Animals Per Dose Level : 5 males and 5 females
Total Number of animals: 20
Administration of the Test Article: One single dose, per os
Observations and Records:
Mortality: Daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and Symptoms: daily
Body weight: On days 1, 7, 14 and at death
Necropsy: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
Company standard:
high acute toxicity... LD50 <50 mg/kg
medium acute toxicity... LD50 50 - 500 mg/kg
slight acute toxicity... LD50 500 - 5000 mg/kg
practically no acute toxicity....LD50 >5000 mg/kg - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95% confidence limit were computed by the logit method.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One of females was dead at the level of 5000 mg/kg bw in the first day of post-exposure period.
- Clinical signs:
- other: Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute test. In addition, the high dose animals showed sedation, tremor and ventral body position.
- Gross pathology:
- Besides two spotted lungs no gross lesions were found at necropsy.
Any other information on results incl. tables
TABLE 2 BODY WEIGHTS AND STANDARD DEVIATIONS (GMS)
males | female | |||||
dose mg/kg | day 1 | day 7 | day 14 | day 1 |
day 7 |
day 14 |
1000 |
202/6.7 |
268/15.4 |
317/13.3 |
180/9.0 |
211/9.4 |
236/15.2 |
5000 |
198/6.8 |
223/11.5 |
265/23.9 |
179/5.5 |
196/11.6 |
221/11.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU-CLP
- Conclusions:
- Based on the current condition, TK 10529 has practically no acute toxicity when administered orally to the albino rat.
LD50(oral, rat): >5000mg/kg bw in rats of both sexes - Executive summary:
Upon an acute oral administration and a 14 day post-treatment observation period, the LD50 determined for test substance is greater than 5000 mg/kg bw (no 95% confidence limits calculated, as not possible). Twenty animals were administered orally by gavage at concentrations of 1’000 an 5’000 mg/kg bw. Dyspnoea, exophthalmus, ruffled fur and curved body position were seen, being common symptoms in acute test. In addition, the high dose animals showed sedation, tremor and ventral body position. However, lack of any clear dose-relation or adverse effects on body weight, gross pathological appearance indicated an absence of toxicity. Thus, it can be concluded that test substance exerts no toxic influence in rats of either sex at levels up to 5’000 mg/kg bw.
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.