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EC number: 601-593-4 | CAS number: 119302-19-1
- 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:
- 28 October 1997 - 20 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The acute oral toxicity study was conducted according to EU Method B.1 and OECD Guideline Method 423 without deviations and GLP practices.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol
- EC Number:
- 601-593-4
- Cas Number:
- 119302-19-1
- Molecular formula:
- C23H37NO2
- IUPAC Name:
- (1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Epyrrol
- Substance type: pure active substance
- Physical state: Powder, off white in color
- Composition of test material, percentage of components: Main component= 75%, other= 18%, other= 7%
- Lot/batch No.: GL-1291 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Not indicated
- Storage condition of test material: Stable at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after treatment of the test substance
- Housing: Group house of 3 animals per sex per cage in labelled polycarbonatge cages
- Diet (e.g. ad libitum): Standard pelleted laboratory diet (from Carfil Quality BVBA, Oud-Turnout, Belgium), Ad libitum
- Water (e.g. ad libitum): Tap-water, ad libitum
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Not documented in the report To: Not documented in the report
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- DOSAGE PREPARATION (if unusual): The formulations (w/w) were prepared immediately prior to dosing. Adjustment was made for specific gravity of the vehicle. The concentration of the test sustance in vehile was varied to allow constant dosage volume in terms of ml/kg body weight. Homogeneity was accomplished to a visually acceptable level.
- Doses:
- 2000 mg/kg bw, 200 mg/kg bw, and 25 mg/kg bw
- No. of animals per sex per dose:
- 3/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability was observed twice daily; body weights were recorded on Day 1 (pre-administration, 8 and 15 and at death (if found dead after Day 1); Clinical signs were periodically observed on the day of dosing (Day 1) and once daily thereafter, until Day 15 (the time of onset, degree and duration were recorded and the symptoms graded according to fixed scales: Max grade 4= drading slight (1) to very severe (4), Max grade 3= drading slight (1) to severe (3), Max grade 1= presence is scored (1)).
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed by asphyxiation using a oxygen/carbon dioxide procedure and subject to necropsy. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 25 - 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals dosed at 2000 or at 200 mg/kg were found dead on day 2 or day 3, respectively. The surviving animals had recovered from the symptoms by day 2.
- Clinical signs:
- other: Clinical signs observed during the study period were as follows: 25 mg/kg: Uncoordinated movements (females only) 200 mg/kg: Lethargy, hunched posture, uncoordinated movements and piloerection. 2000 mg/kg: Lethargy, tremors, uncoordinated movements and p
- Gross pathology:
- Yellowish discoloration of all adipose tissue and reddish watery fluid in the thoracic and/or abdominal cavity were found in the 200 mg/kg treated animals at macroscopic post mortem examination. No abnormalities were found in the other dose groups.
Any other information on results incl. tables
Inadvertently, no animals observations were performed on Day 11 (males) and on Day 13 (females) of the 25 mg/kg dose group. Based on the previous observation, it was considered that this evernt has not adversely effected the study integrity.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50 value of Epyrrol in Wistar rats was established to be within the range of 25-200 mg/kg body weight.
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