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EC number: 264-438-6 | CAS number: 63738-22-7
- 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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- method of administration unclearly defined: using a metal
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
- EC Number:
- 264-438-6
- EC Name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
- Cas Number:
- 63738-22-7
- Molecular formula:
- C20H28N2O4
- IUPAC Name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
1
- Specific details on test material used for the study:
- Lot: V-156
Expected purity: 75%
Appearance: light yellow highly viscous liquefied substance
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals.
- Age at study initiation: 4 weeks upon arrival
- Weight at study initiation: 99 ± 3.3g (male) and 83 ± 2.5g (female)
- Fasting period before study: One night prior to the test. Feeding was resumed three hours after administration.
- Housing: Ten animals were housed in a cage
- Diet: ample food
- Water: ample water
- Acclimation period: Tamed under breeding circumstances for one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2.0 C
- Humidity (%): 45 to 85
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
1.170 mL/ kg and 0.988 mL/ kg of undiluted substance for male and female animals, respectively. - Doses:
- Males: 0.392, 0.485, 0.606, 0.714, 0.825, 0.918 and 1.170 mL/ kg bw
Females: 0.349, 0.471, 0.588, 0.741, 0.864 and 0.988 mL/ kg bw - No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Remarks:
- no administration
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight was recorded at 0, 1, 3, 5, 8, 11 and 14 days after exposure.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight are recorded. - Statistics:
- LD50 values are calculated according to the Probit method.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 630 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Corresponding to a dose level of 0.55 mL/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 730 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Corresponding to a dose level of 0.63 mL/kg bw
- Mortality:
- 1/10, 5/10, 3/10, 5/10, 6/10, 9/10 and 10/10 males died in observation period after exposure period to 0.392, 0.485, 0.606, 0.714, 0.825, 0.918 and 1.170 mL/ kg bw, respectively.
0/10, 5/10, 7/10, 6/10, 8/10 and 10/10 females died in the observation period after exposure period to 0.349, 0.471, 5.88, 0.741, 0.864 and 0.988 mL/ kg bw, respectively.
The mortalities occurred on day 4 to 8 of the 14-day observation period. No deaths occurred in the control group. - Clinical signs:
- other: No toxic symptoms were noted for 2 days after administration, but severe diarrhoea, reddish brown vomit or lacrimation, decline of spontaneous movement and blephroptosis were suddenly observed on and after the third day after administration in the order o
- Gross pathology:
- As to rats that died during the test, ulceration or necrosis was observed in the stomach and intestinal canal. Such symptoms in the stomach were particularly pronounced. No remarkable change was observed in other organs. As to rats that lived for 14 days, the accretion of the stomach (mainly anteriorly) with thoracie peritoneum was observed in the male group with a tendency to increasing accretion at higher doses. No extreme change was observed in the female group.
Any other information on results incl. tables
Calculation of LD50 value according to Probit method.
Male: 0.63 mL/kg (0.53-0.73 mL/kg, p=0.05) = 730 mg/kg (610-840 mg/kg, p= 0.05)
Female: 0.55 mL/kg (0.45-0.64 mL/kg, p=0.05) = 630 mg/kg (520- 730 mg/kg, p=0.05)
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity test showed a LD50 of 630 and 730 mg/kg bw for female and male rats, respectively.
- Executive summary:
A pre-guideline study, similar to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. Although the details on administration are not very clearly described, it is clear that the substance was administered by gavage. In this study 10 conventional Wistar rats were used per sex and per dose group, which were observed for 14 days post administration. In the males, administration of 0.392, 0.485, 0.606, 0.714, 0.825, 0.918 and 1.170 mL/ kg bw resulted in mortality in 1/10, 5/10, 3/10, 5/10, 6/10, 9/10 and 10/10 of the animals, respectively. For females exposed to 0.349, 0.471, 5.88, 0.741, 0.864 and 0.988 mL/ kg bw mortality was observed in 0/10, 5/10, 7/10, 6/10, 8/10 and 10/10 of the animals, respectively. No mortality was observed in the control (untreated) group. The Probit method was used to calculate the LD50 values, which were determined to be 630 mg/kg bw (0.55 mL/kg bw) for females and 730 mg/kg bw (0.63 mL/kg bw) for males.
Clinical signs were noted from day 2 till the end of the observation period and included severe diarrhoea, reddish brown vomit or lacrimation, decline of spontaneous movement and blephroptosis. Rats succumbing during observation exhibited ataxia and oppression in breathing before death. Bodyweight was reduced in a dose dependent manner between day 1 and 5 if compared to the bodyweight at day 0. During the whole observation period, the absolute bodyweight of the treated animals was lower compared to the controls. Necropsy revealed ulceration or necrosis in the stomach and intestinal canal of the rats that died during the observation period. In these rats no remarkable change was observed in other organs. As to rats that lived for 14 days, the accretion of the stomach (mainly anteriorly) with thoracie peritoneum was observed in the male group with a tendency to increasing accretion at higher doses. No extreme change was observed in the female group. Based on the LD50 values obtained, the substance is considered to be acutely harmful Category 4.
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