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EC number: 200-834-7 | CAS number: 75-04-7
- 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
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Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1978 - August 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- September 2009
- Deviations:
- not specified
- Remarks:
- Only limited information regarding animal acclimatization, animal husbandry and inhalation chamber conditions is given. Recods of bodyweights only performed on day 7 and 14 after exposure.
- GLP compliance:
- no
- Remarks:
- predating GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethylamine
- EC Number:
- 200-834-7
- EC Name:
- Ethylamine
- Cas Number:
- 75-04-7
- Molecular formula:
- C2H5NH2
- IUPAC Name:
- ethanamine
- Details on test material:
- - Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Purity: approx. 100%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Mura: SPRA (SPF 68 Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MUS Rattus, Brunnthal (Germany)
- Weight at study initiation: mean 185 ± 15
- Fasting period before study: None
- Diet: Herilan MRH, Eggersmann KG, Rinteln/Weser, Germany; ad libitum
- Water: Tap water; ad libitum
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body inhalation system
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: Caged in groups of 5
- Source and rate of air: 3000 L air/h
- Method of conditioning air: Gas bottle combined with a regulating valve and a mixing chamber to mix fresh air and gaseous test item
- Pressure in air chamber: Approx. - 10 Pa
TEST ATMOSPHERE
- Brief description of analytical method used: Test substance concentrations were analytically measured by determining the total organic carbon concentration using a calibrated flame ionization
- Samples taken from breathing zone: Yes
- Rationale for the selection of the starting concentration: An estimated concentration based on experiences with a inhalation risk test was chosen. One dosage allowed the calculation of a no effect level (LC0). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- 0.9 L/h were analysed
- Duration of exposure:
- 4 h
- Remarks on duration:
- By using the Haber's law the LC50 after 1h exposure duration was calculated
- Concentrations:
- Dose group 1: 1.15 mg/L (622 ppm)
Dose group 2: 5.45 mg/L (2954 ppm)
Dose group 3: 6.85 mg/L (3714 ppm)
Dose group 4: 7.52 mg/L (4105 ppm)
Dose group 5: 8.21 mg/L (4453 ppm)
Dose group 6: 11.58 mg/ L (6255 ppm)
The analyzed concentrations in the 1st test were 1150, 5450, and 8210 mg/m3 and in the 2nd test 6850, 7520 and 11580 mg/m³. - No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily for clinical signs and mortality; Body weights were measured prior to, and then 7 and 14 days after exposure to the test substance
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, mortality, mean body weight per dose group - Statistics:
- - Probit analysis
- The LC50 values for 1 hour exposure duration were calculated by using the Haber's law C x t = k
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 12.6 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 9.8 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 8.1 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- Mortality was observed for the dose groups 2, 5 and 6 (5.45 mg/L, 8.21 mg/L, 11.58 mg/L). The animals died within the period of the 4h treatment until day 9 after exposure.
For detailed information see Table 1 in "Any other information on results incl. tables" - Clinical signs:
- other: Clinical symptoms were grooming, eye closure, corrosive effects to nose (red discharge), eye lid and cornea (blurred), swollen eyes, dyspnea, gasping and apathy, scrubby coat, salivation, tiptoeing and staggering gait. Clinical symptoms were observed for
- Body weight:
- Treatment related effects on the bodyweight gain were observed. After 7 days of observation male and female rats of the dose groups 2 to 6 gained apparently less weight compared to untreated control rats.
For detailed information see Table 2 in "Any other information on rsults incl. tables"
After 7 days men bodyweight development was positive in the control group, the low dose group, and the 7520 dose group. Except the 8210 mg/m³ dose group Mean body weight development was positive after 14 days. - Gross pathology:
- Deceased animals:
- Pathological findings especially at the heart and lung
- Observations: Gas swolen bowel, distended lungs, hyperemia of the lung, lung edema, heart dilatation and hyperemia
Survivors: Organs without findings
Any other information on results incl. tables
Table 1: Mortality after 14 d for male and female rats
Exposure concentration [mg/L] |
Mortality Males |
Mortality Females |
Mortality Males/Females |
Mortality Males/Females [%] |
1.15 |
0/10 |
0/10 |
0/20 |
0 |
5.45 |
2/10 |
1/10 |
3/20 |
15 |
6.85 |
0/10 |
0/10 |
0/20 |
0 |
7.52 |
0/10 |
0/10 |
0/20 |
0 |
8.21 |
10/10 |
7/10 |
17/20 |
85 |
11.58 |
5/10 |
1/10 |
6/20 |
30 |
Table 2: Mean body weight gain for male and female rats after 7 d and 14 d post-exposure period
Exposure concentration [mg/L] |
Mean body weight gain after 7 d [g] |
Mean body weight gain after 14 d [g] |
||
Male |
Female |
Male |
Female |
|
Control |
+ 40 |
+ 17 |
+ 72 |
+ 29 |
1.15 |
+ 32 |
+ 12 |
+ 62 |
+ 25 |
5.45 |
- 8 |
- 11 |
+ 40 |
+ 9 |
6.85 |
- 3 |
- 4 |
+ 46 |
+ 21 |
7.52 |
+ 10 |
+ 8 |
+ 59 |
+ 21 |
8.21 |
/ |
- 29 |
/ |
- 5 |
11.58 |
- 19 |
- 10 |
+ 29 |
+ 19 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the available study results, the test item provokes inhalative toxic effects after a 4 hour gas exposure period in rats. The mean lethal concentration was calculated to be 8.1 mg/L for females, 9.8 mg/L for males and 12.1 mg/L for male and female rats.
- Executive summary:
Acute inhalation toxicity was analyzed in a study performed similar to OECD Guideline 403. Wistar rats were dosed with 1.15; 5.45; 6.85; 7.52; 8.21; and 11.58 mg/L of gaseous test item. After a 4 h exposure mortality was observed for the dose groups 5.45 mg/L, 8.21 mg/L and 11.58 mg/L amounting 15%, 85% and 30%, respectively. Based on this observations a LC50 of 9.8 mg/L air for males and 8.1 mg/L air for females and a combined LC50 of 12.6 mg/L air was calculated. Main clinical signs observed were eye closure, corrosive effects to nose (red discharge) and cornea (blurred), swollen eyes, dyspnea and apathy, scrubby coat, salivation, tip-toeing and staggering gait. With the exeption of the 1.15 mg/L exposure scenario clinical symptoms were observed until the end of the 14 d observation period. At necropsy, a gas swolen bowel, distended lungs, hyperemia of the lung, lung edema, heart dilatation and hyperemia were observed. Based on the most sensitive LC50 for females of 8.1 mg/L (equivalent to 4320 ppmV) the test substance can be categorized for inahalative toxicity cat. 4 based on GHS criteria.
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