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EC number: 218-259-5 | CAS number: 2095-06-9
- 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:
- 02 - 16 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- EC Number:
- 275-662-9
- EC Name:
- m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- Cas Number:
- 71604-74-5
- Molecular formula:
- C15H19NO4
- IUPAC Name:
- 3-(oxiran-2-ylmethoxy)-N,N-bis(oxiran-2-ylmethyl)aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Substance type: Clear slightly yellow very viscous liquid
- Purity: 100% Mono constituent substance
- Storage condition of test material: In refrigerator (2-8°C) in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: Animals used withihn the study were at least 6 weeks old.
- Weight at study initiation: Body weights were at least 1.0 kg.
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 Harlan Teklad, Italy). Hay and wooden sticks were available during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
IN-LIFE DATES: From: 02 - 16 April 2013
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of eye irritation observed in the first animal.
PREEMPTIVE PAIN MANAGEMENT
Both eyes were topically anaesthetized using a local anaesthetic (Lidocaine eye drops, AST Farma BV, Woerden, The Netherlands). Approximately 10 minutes prior to treatment, 1 drop was applied to the eyes. No routine pretreatment with a systemic analgesic was done. The subcutaneous injection was
considered to cause unwanted additional distress, since in the majority of cases instillation of test materials does not cause much distress in the topically anesthetized eye. No post-treatment with systemic analgesics were needed.
TREATMENT
Each animal was treated by instillation of 0.1 mL of the test substance, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. This procedure was repeated to assess recovery in two animals. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).
REMOVAL OF TEST SUBSTANCE
-Washing: No
OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation) and after the final observation.
- Necropsy: No necropsy was performed according to protocol.
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 or 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- other: 24, 48 and 72 hrs.
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Irritation: Instillation of 0.1 mL of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. Slight dulling of the normal luster of the cornea was observed after 24 hours in two animals (maximum 25% of the corneal area) and after 48 hours in the remaining animal (maximum 50% of the corneal area). Fluorescein staining showed epithelial damage on the cornea (maximum 10% of the corneal area) in two animals. The corneal injury resolved within 72 hours. Iridial irritation grade 1 was observed in two animals and resolved within 48 or 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely
resolved within 7 days in all animals.
Corrosion: There was no evidence of ocular corrosion. - Other effects:
- Colouration/Remnants: No staining of (peri) ocular tissues by the test substance was observed. Remnants of the test substance were present on the outside of the eyelids of all animals on Days 1 and 2.
Toxicity/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: \\\Slightly irritating to eyes, but insufficient for classification.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study with rabbits, performed according to OECD 405 guideline and GLP principles, irritation was observed.
Based on the results m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline does not have to be classified and has no obligatory labelling requirement for skin irritation according. - Executive summary:
m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline was tested in an eye irritation study with rabbits, performed according to OECD 405 guideline and GLP principles.
Instillation of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. Slight dulling of the normal luster of the cornea was observed after 24 hours in two animals (maximum 25% of the corneal area) and after 48 hours in the remaining animal (maximum 50% of the corneal area). Fluorescein staining showed epithelial damage on the cornea (maximum 10% of the corneal area) in two animals. The corneal injury resolved within 72 hours. Iridial irritation grade 1 was observed in two animals and resolved within 48 or 72 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 7 days in all animals. There was no evidence of ocular corrosion.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Based on the results m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline does not have to be classified and has no obligatory labelling requirement for eye irritation according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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