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EC number: 275-662-9 | CAS number: 71604-74-5
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral and dermal studies with m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline performed in accordance with current OECD/EC test guidelines and GLP principles, showed LD50 values of 300-2000 mg/kg bw for acute oral toxicity, and of > 2000 mg/kg for acute dermal toxicity in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 11, 2012 - November 06, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, April 2011, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 11-12 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Fasting period before study: overnight prior to dosing and until 3-4 hours after administration
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- GAVAGE METHOD: plastic feeding tubes.
Frequency: single dosage, on Day 1.
VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight.
DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and test substance (specific gravity of 1.220 was used for calculation). No correction was made for purity of the test substance. - Doses:
- 2000 and 300 mg/kg body weight
- No. of animals per sex per dose:
- 2000 mg/kg: 3
300 mg/kg: 6 (2 groups of three females in a stepwise manner) - Control animals:
- no
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15 and at death (if found dead after Day 1).
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities recorded.
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD50 cut-off value was considered to be 500 mg/kg body weight.
- Mortality:
- All animals at 2000 mg/kg (3/3) were found dead on Day 1 or 2. No mortality was observed at 300 mg/kg.
- Clinical signs:
- other: All three animals at 2000 mg/kg showed hunched posture and piloerection on Day 1. One animal at 2000 mg/kg showed lethargy and uncoordinated movements on that day. No clinical signs were noted at 300 mg/kg.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Beginning of autolysis was noted in two animals at 2000 mg/kg which were found dead on Day 2. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD 423 test guideline and GLP principles, an LD50 value was established to be within the range of 300-2000 mg/kg body weight.
- Executive summary:
The test substance was assessed for toxicity in an acute oral toxicity study with female Wistar rats, performed according to OECD 423 test guideline and GLP principles. Initially, m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline was administered to three rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of females were dosed at 300 mg/kg body weight.
All animals at 2000 mg/kg (3/3) were found dead on Day 1 or 2. No mortality was observed at 300 mg/kg. All three animals at 2000 mg/kg showed hunched posture and piloerection on Day 1. One animal at 2000 mg/kg showed lethargy and uncoordinated movements on that day. No clinical signs were noted at 300 mg/kg. The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
No abnormalities were found at macroscopic post mortem examination of the surviving animals. Beginning of autolysis was noted in two animals at 2000 mg/kg which were found dead on Day 2.
Based on the results, the oral LD50 value of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
According to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
- Quality of whole database:
- The study has klimisch code 1.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 29, 2012 - December 13, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, April 2011; including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:WI (Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 11 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Individually housed in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
The formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
Frequency: Single dosage, on Day 1.
Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at WIL Research Europe and on test substance data supplied by the sponsor.
Dose volume: 10 mL/kg body weight
DOSAGE PREPARATION: The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle (1.036) and specific gravity of the test substance (1.220 was used). No correction was
made for purity of the test substance.
Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none. - Statistics:
- None.
- 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 and/or flat posture, chromodarcryorrhoea and piloerection, were noted in the majority of animals on Days 1 and/or 2. One male showed ptosis and one female showed tremor on Days 1 and/or 2.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- General, focal or maculate erythema, necrosis, scabs and scales were seen in the treated skin-area of the animals during the observation period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD 402 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
The test substance was assessed for toxicity in an acute dermal toxicity study with female Wistar rats, performed according to OECD 402 test guideline and GLP principles.
No mortality occurred. Hunched and/or flat posture, chromodarcryorrhoea and piloerection, were noted in the majority of animals on Days 1 and/or 2. One male showed ptosis and one female showed tremor on Days 1 and/or 2. General, focal or maculate erythema, necrosis, scabs and scales were seen in the treated skin-area of the animals during the observation period.
Five males and three females showed body weight loss in the first week. In the second week these animals recovered and showed body weight gain. The two remaining females showed body weight gain in the first and second week.
No abnormalities were found at macroscopic post mortem examination of the animals.
Based on the results the dermal LD50 value of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline in Wistar rats was
established to exceed 2000 mg/kg body weight.
The test substance, m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study has klimisch code 1.
Additional information
Oral:
The test substance was assessed for toxicity in an acute oral toxicity study with female Wistar rats, performed according to OECD 423 test guideline and GLP principles. Initially, m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline was administered to three rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of females were dosed at 300 mg/kg body weight.
All animals at 2000 mg/kg (3/3) were found dead on Day 1 or 2. No mortality was observed at 300 mg/kg.
All three animals at 2000 mg/kg showed hunched posture and piloerection on Day 1. One animal at 2000 mg/kg showed lethargy and uncoordinated movements on that day. No clinical signs were noted at 300 mg/kg. The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
No abnormalities were found at macroscopic post mortem examination of the survivinganimals. Beginning of autolysis was noted in two animals at 2000 mg/kg which were found dead on Day 2.
Based on the results, the oral LD50 value of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
Dermal:
The test substance was assessed for toxicity in an acute dermal toxicity study with female Wistar rats, performed according to OECD 402 test guideline and GLP principles.
No mortality occurred. Hunched and/or flat posture, chromodarcryorrhoea and piloerection, were noted in the majority of animals on Days 1 and/or 2. One male showed ptosis and one female showed tremor on Days 1 and/or 2. General, focal or maculate erythema, necrosis, scabs and scales were seen in the treated skin-area of the animals during the observation period.
Five males and three females showed body weight loss in the first week. In the second week these animals recovered and showed body weight gain. The two remaining females showed body weight gain in the first and second week.
No abnormalities were found at macroscopic post mortem examination of the animals.
Based on the results the dermal LD50 value of m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline in Wistar rats was
established to exceed 2000 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
One study available.
Justification for selection of acute toxicity – dermal endpoint
One study available.
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline should be classified for acute oral toxicity as Category 4 and should be labeled as H302: Harmful if swallowed.
m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline does not have to be classified for acute dermal toxicity to Regulation (EC) No 1272/2008.
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