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EC number: 216-032-5 | CAS number: 1477-55-0
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study, no deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- m-phenylenebis(methylamine)
- EC Number:
- 216-032-5
- EC Name:
- m-phenylenebis(methylamine)
- Cas Number:
- 1477-55-0
- Molecular formula:
- C8H12N2
- IUPAC Name:
- 1-[3-(aminomethyl)phenyl]methanamine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): m-Xylylendiamin
- Physical state: Liquid
- Stability under test conditions: Stable (report No 05L00082)
- Storage condition of test material: Room temperature under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Stated in report
- Age at study initiation: 7-9 weeks (m) 10-13 (f)
- Weight at study initiation: 212 - 288g (m) 191 - 216g (f)
- Fasting period before study: Not stated
- Housing: Individually Type DK III cages
- Diet (e.g. ad libitum): KLIBA mouse/rat laboratory diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%):30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:03 Feb 2005 - 02 Mar 2005
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: INA 20
- Exposure chamber volume: 55L
- Method of holding animals in test chamber: Glass tubes
- Source and rate of air: compressed air, 1.5 m3/hr
- System of generating particulates/aerosols: Continuous infusion pump Perfusor VII, Two component atomizer Mod. 970
- Method of particle size determination: Stack Sampler Mark III
TEST ATMOSPHERE
- Brief description of analytical method used: Air sampler GS 312 (DESAGA), Gas Chromatography
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 0.74, 1.35, 5.2 mg/L
Mass median aerodynamic diameter between 1.8 and 3.5 µm - 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: Week days, twice daily. Weekend, daily. Weight, weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 1.34 mg/L air (analytical)
- Based on:
- test mat.
- 95% CL:
- ca. 0.99 - ca. 4.34
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- ca. 1.38 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- ca. 1.16 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All male and female animals died at 5.2 mg/l, two of five males and three of five females died at 1.35 mg/l and one of five females but no males died at 0.74 mg/l, respectively. The lethality's occurred until study day 3
- Clinical signs:
- other: Clinical signs of toxicity in animals exposed to 0.74 mg/l comprised visually accelerated respiration, pulmonary respiration sounds, squatting posture, piloerection and contaminated fur. Findings were observed from h0 of exposure until including study day
- Body weight:
- The mean body weights of the animals increased throughout the study period
- Gross pathology:
- Test group 1 (0.74 mg/l)
No gross pathological abnormalities were noted in the female animal that died 1 day after exposure. However, necropsy findings of 2 males sacrificed at termination of the study comprised diffuse red discoloration and edema of all lung lobes and diffuse red discoloration of all lung lobes in 3 males and 4 females.
Test group 2 (1.35 mg/l)
No gross pathological abnormalities were noted in the animals necropsied at termination of the post exposure observation period and in 2 female animals that died during exposure and 1 male and 1 female animal that died 1 day after exposure.
The following gross pathological abnormality was detected in 1 male animal that died 2 days after exposure: diffuse red discoloration of all lung lobes.
Test group 3 (5.2 mg/l)
Necropsy findings of the animals that died during exposure (4 males and 4 females) comprised diffuse red discoloration of all lung lobes with partly sunken surface. The animal body showed wet fur and white contamination in the region of the head.
Necropsy findings of the 2 animals (1 male and 1 female) that died after exposure (d2; d3) comprised red discoloration of all lung lobes, partly focal. The animals showed slight red discoloration of content of the small intestine and moderate dilatation was seen in the small intestine or in the large intestine of the male animal, additionally.
Any other information on results incl. tables
Clinical signs of toxicity in animals exposed to 1.35 mg/l comprised visually accelerated respiration, pulmonary respiration sounds, squatting posture, piloerection, exsiccosis, reduced general state and smeared and contaminated fur. Findings were observed from h0 of exposure until including study day 14. The mean body weights of the surviving male animals increased throughout the study period. The mean body weights of the surviving female animals decreased during the first post exposure observation week but increased during the second week. No gross pathological abnormalities were noted in the animals necropsied at termination of the post exposure observation period, in two female animals that died during exposure and 1 male and 1 female animal that died 1 day after exposure. The following gross pathological abnormality was noted in 1 male animal that died 2 days after exposure: diffuse red discoloration of all lung lobes. The clinical signs of toxicity in animals exposed to 5.2 mg/l were comparable to test group 2 (1.35 mg/l). Gasping, formation of nasal crusts and apathy in 1 male and 1 female animal were observed additionally. Findings were observed from hour 0 of exposure until including study day 1.
No body weight development of the male and female animals could be determined because all animals died within 3 days after exposure. Necropsy findings of the animals that died during exposure (4 males and 4 females) comprised diffuse red discoloration of all lung lobes with partly sunken surface. The animal body showed wet fur and white contamination in the region of the head. Necropsy findings of the 2 animals (1 male and 1 female) that died after exposure (d2; d3) comprised red discoloration of all lung lobes, partly focal. The animals showed slight red discoloration of content of the small intestine and moderate dilatation was seen in the small intestine or in the large intestine of the male animal, additionally. Under the conditions of this study the LC50 for male and female rats after liquid aerosol inhalation was calculated to be 1.34 mg/l.
Mean body weights (g)
|
Test concentration mg/L |
Day 0 |
Day 7 |
Day 14 |
Male |
0.74 |
241.6 |
250.3 |
287.0 |
Female |
0.74 |
216.7 |
224.8 |
245.4 |
Male |
1.35 |
212.6 |
22.3 |
262.6 |
Female |
1.35 |
191.7 |
179.9 |
196.4 |
Male |
5.2 |
288.3 |
- |
- |
Female |
5.2 |
211.3 |
- |
- |
Mortality
Concentration (mg/L) |
0.74 |
1.35 |
5.2 |
|
Mortality |
Male |
0 |
2 |
5 |
Female |
1 |
3 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The combined LC50 is 1.34 mg/L
The LC50 was found to be 1.16 mg/L for female animals and 1.38 mg/L for male animals
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