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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 November 1997 - 6 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 405 and EU Method B.5 (Acute Eye Irritation/Corrosion) 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:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Neitherlands
- Age at study initiation: At least six weeks old
- Weight at study initiation: Less then 3.5 kg
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm., Hope Farms, Woerden, The Neitherlands), approximately 100 grams/day. Additionally, hay was provided once a week.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water
- Acclimation period: At least 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C
- Humidity (%): 50%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Not provided in study report To: Not provided in study report
Test system
- Vehicle:
- not specified
- Controls:
- other: Treatment was only applied to one eye, the other eye served as the control for each animal.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 29.9 +/- 0.3 mL (0.1 mL volume) - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- Up to 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): A solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled in both eyes of each animal.
- Time after start of exposure: 24 hours after treatment
SCORING SYSTEM: Evaluation of eye reactions were based on a numerical scoring system used to score eye lesions, evaluating the corneal irritation (scale of 0-4), iris (scale of 0-2), conjunctival irritation (scale of 0-3), chemosis (scale of 0-4), and discharge (scale of 0-3), with 0 being the low end of the scoring system and/or no effects.
TOOL USED TO ASSESS SCORE: Fluorescein, although in case standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Installation of approximately 30 mg of Epyrrol (a volume of ~ 0.1 mL) into one eye of each of three rabbits resulted in effects on the cornea, iris, and conjunctivae.
The Corneal injury consisted of opacity (maximum grades 2-3) and epithelial damage (maximum 75% of the corneal area).
Iridic irritation grade 1 was observed in all animals.
In all animals, approximately 25% of the cornea and iris could not be scored, due to oedema of the eyelids, 24 and/or 48 hours after instillation.
In one animal, approximately 35% of the iris could not be scored after 48 and 72 hours, due to the corneal injury.
The irritation of the conjunctivae consisted of readness, chemosis and discharge. Necrosis of the ocular tissue was observed in all animals from 24 hours after instillation onwards.
No signs of an early recovery of the ocular injury was observed. It was therefore decided to terminate the study and to sacrifice the animals for ethical reasons immediately after the 72 hour observation. - Other effects:
- Remnants of the test substance coloration were present in the eyes of all animals on Day 1.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Animal # | 1467 | 1468 | 1483 | ||||
Time after Dosing | Tissue/ Finding | Score Fluor. Area (%) | Comments | Score Fluor. Area (%) | Comments | Score Fluor. Area (%) | Comments |
1 hour | Corneal Opacity | 2 | D | 2 | D | 2 | D |
Corneal Opacity area | 2 | 1 | 1 | ||||
Iris | 1 | 1 | 1 | ||||
Conj. Redness | 3 (A) | 3 (B) | 2 (ABC) | ||||
Conj chemosis | 4 (ABC) | 3 (ABC) | 3 (ABC) | ||||
Discharge | 1 | 2 | 2 | ||||
24 hours | Corneal Opacity | 2 | 75 E | 2 | 75 E | 2 | 75 E |
Corneal Opacity area | 3 | 3 | 3 | ||||
Iris | 1 | 1 | 1 | ||||
Conj. Redness | 3 (AB) | 3 (B) | 3 (B) | ||||
Conj chemosis | 4 (ABC) | 4 (ABC) | 4 (ABC) | ||||
Conj. Discoloration * | B | B | B | ||||
Discharge | 1 | 2 | 3 | ||||
48 hours | Corneal Opacity | 2 | E | 3 | - | 3 | F |
Corneal Opacity area | 3 | 1 | 1 | ||||
Iris | 1 | 1 | 1 | ||||
Conj. Redness | 3 (AB) | 3 (ABC) | 3 (ABC) | ||||
Conj chemosis | 4 (ABC) | 3 (ABC) | 4 (B) | ||||
Conj. Discoloration * | AB | b | B | ||||
Discharge | 2 | 3 | 3 | ||||
72 hours | Corneal Opacity | 2 | 75 - | 3 | 75 - | 3 | 75 F |
Corneal Opacity area | 3 | 1 | 2 | ||||
Iris | 1 | 1 | 1 | ||||
Conj. Redness | 3 (ABC) | 3 (ABC) | 3 (ABC) | ||||
Conj chemosis | 4 (A) | 3 (ABC) | 4 (A) | ||||
Conj. Discoloration * | AB | B | AB | ||||
Discharge | 2 | 2 | 2 | ||||
A = Eyelids | |||||||
B = Nictitating membrane | |||||||
C = Sclera | |||||||
D = Remnants of the test substance in the eye | |||||||
E = Approx. 25% of the cornea and iris could not be scored, due to oedema of the eyelids | |||||||
F= Approx. 35% of the iris could not be scored due to corneal damage | |||||||
* Discoloration = Gray/white discoloration of the indicated ocular tissues |
Applicant's summary and conclusion
- Interpretation of results:
- other: Risk of serious damage to the eyes (R41)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the necrosis of the ocular tissues and on the degree and persistence of the corneal injury, it was concluded that ocular corrosion had occurred by instillation of Epyrrol into the rabbit eye in all three animals.
- Executive summary:
Based on the necrosis of the ocular tissues and on the degree and persistence of the corneal injury, it was concluded that ocular corrosion had occurred by instillation of Epyrrol into the rabbit eye in all three animals. Epyrrol has serious risk of irreversible damage to eyes. Eppyrol therefore meets the criteria for classification under CLP as H314, and under DSD as R41.
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