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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 October 1997 - 13 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to OECD guideline 402 and EU Method B.3 (Acute Dermal Toxicity Test) without deviations and GLP practices. .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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
- 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: 298 g (male mean) and 226 g (female 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
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and or flank
- % coverage: 10% of total body surface (25 cm3 for males and 18 cm3 for females (5X5 cm and 3.5X5 cm, respectively))
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressings were removed and residual test substance was removed using a tissue moistened with tap water.
- Time after start of exposure: 24 hours after application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg
- Concentration (if solution): No data
- Constant volume or concentration used: yes - Duration of exposure:
- Single dose
- Doses:
- 2000 mg/kg (10ml/kg) body weight
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability observed twice daily; Body weight observed on Days 1, 8 and 15; Clinical signs observed periodically on Days 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).
- Necropsy of survivors performed: Yes, at the end of the observation period, all animals were sacrificed by asphyxiation using a oxygen/carbon dioxide procedure. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- 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 was noted in one male, between days 5-7. Focal erythema, scales, and scabs on the back and/or flank were noted in the majority of animals from day 3-5 onwards. The animals had recoved from the symptoms between days 7 and 14, although scabs
- Gross pathology:
- No abnormalities were found in the animals at macroscopic post mortem examination.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 for rats treated with a single dermal application was established as exceeding 2000 mg/kg bw as no mortalities were observed.
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.