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EC number: 429-960-2 | CAS number: 27610-48-6
- 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:
- 05.06.1986 to 19.06.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-960-2
- EC Name:
- -
- Cas Number:
- 27610-48-6
- Molecular formula:
- C16H16O4
- IUPAC Name:
- 2-[({6-[(oxiran-2-yl)methoxy]naphthalen-1-yl}oxy)methyl]oxirane
- Details on test material:
- Purity: >99%
Lot N°. B-001
Appearance: Viscous liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Equal numbers of male and female CFY (Sprague-Dawley origin) rats were obtained from Interfauna UK Ltd., (fromely Hacking and Churchill Ltd.), Cambridgeshire, England.
They were in a weight range of 109 to 150 g prior to dosing (Day 1) in the main study and approximately four to six weeks of age. All rats were acclimated to the experimental environment for a period of 7 days prior to the start of the main study.
The rats were allocated to cages within the treatment group. They were housed in groups by sex in metal cages with wire mesh floors. A standard laboratory rodent diet (labsure LAD 1) and water were provided ad Libitum. The batch of diet used for the study was analysed for certain chemical and microbiological contaminants. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The mean daily minimum and maximum temperatures of the animal room were 22°C and 25°C respectively and the mean daily relative humidity value was 54%. The rate of air exchange was maintained at approximately 15 air changes/hour. lighting was controlled by means of a time switch to 12 hours artificial in each 24 hour period.
Each animal was identified by cage number and ear punching.
Each cage was identified by a coloured label displaying the dose level, study schedule number and the initials of the study Director.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Preliminary study:
-A trial test was carried out to establish a dosing regimen using groups of two male and two female rats at two dose levels of 1.0 and 5.0 g/kg bodyweight.
Main study:
-A group of ten rats (five males and five females) was treated at 2.0 g/kg bodyweight. - Doses:
- -Preliminary study: 1.0 and 5.0 g/kg bodyweight
-Main study: 2.0 g/kg bodyweight. - No. of animals per sex per dose:
- -Preliminary study: 2 males and 2 females rats.
-Main study: ten rats (5 males and 5 females) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals fot the remainder of Day1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observations was at approximately 16.30 hours on weekdays or 11.30 hours on Saturday and Sunday. Clinical signs were recorded at each observation.
The animals on the preliminary study were observed for 5 days (dose 1.0 g/kg) or 7 days (dose 5.0 g/kg). Those on the main study were observed for 14 days after dosing.
Individual bodyweights of rats on Day 1 (day of dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights.
Results and discussion
- Preliminary study:
- A trial test was carried out to establish a dosing regimen using groups of two male and two female rats at two dose levels of 1.0 and 5.0 g/kg bodyweight. Losses of bodyweight were recorded on Day 8 for each of the three rats surviving administration of Epiclon EXA-4032 at 5.0 g/kg. Autopsyof these animals on Day 8 revealed gross thickening of the gatsric epithelium and adhesions of the stomach to the abdominal wall and adjacent viscera. Thus, although the preliminary study indicated the acute median lethal oral dose of Epiclon EXA-4032 was in the region of 5.0 g/kg, it was inappropriate to establish the LD50with greater precision on humane grounds. The study was completed by demonstrating that the lethal threshold dose (acute lethal dose) of Epiclon EXA-4032 was greater than 2.0 g/kg bodyweight.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths following a single oral dose of EPICLON EXA-4032 at 2.0 g/kg bodyweight.
- Clinical signs:
- other: Signs of reaction to treatment seen in all rats during the first three days of the observation period were pilo-erection and abnormal body carriage (hunched posture). All rats showed pallor of the extremities between days 8 and 11. Recovery, as judged by
- Gross pathology:
- Terminal autopsy revealed thickening or ulceration of the epithelium of the non-glandular zone of the stomach and adhesions of the stomach to the diaphragm, adjacent viscera and or the abdominal wall.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, the acute lethal oral dose to rats of EPICLON EXA-4032 was found to be greater than 2.0g/kg bodyweight.
LD50>2.0 g/kg bodyweight. - Executive summary:
This study was designed to assess the toxicity following a single oral dose and to determined the LD50.
The LD50 of EPICLON EXA-4032 was determined and the experimental procedure was based on the Testing Guidelines as given in Federal Register Vol.50 N°. 188, PartII dated 27 September 1985.Section 798.1175 -Acute Oral Toxicity.
For this experiment, a preliminary study was done to establish a dosing regimen using groups of 2 male and 2 female rats at 2 doses levels of 1.0 and 5.0 g/kg.
For the main study, a group of ten rats (five males and five females) was treated at 2.0 g/kg bodyweight..
The dose volume of the etst substance was administred to each rat using a syringue and plastic catheter and te viscosity of the test substance prevented it's administartion in the undiluted state.
In conclusion, the acute lethal oral dose to rats of EPICLON EXA-4032 was found to be greater than 2.0g/kg bodyweight.
LD50>2.0 g/kg bodyweight.
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