Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-372-4 | CAS number: 106-20-7
- 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: 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- (adopted 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- BASF AG, Department of Toxicology
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl)amine
- EC Number:
- 203-372-4
- EC Name:
- Bis(2-ethylhexyl)amine
- Cas Number:
- 106-20-7
- Molecular formula:
- C16H35N
- IUPAC Name:
- bis(2-ethylhexyl)amine
- Details on test material:
- - Name of test material (as cited in study report): Di-2-ethylhexylamin
- Physical state: liquid / colourless
- Analytical purity: 99.6 %
- Lot/batch No.: GLP 89/722
- Stability under test conditions: Stability was ensured for at least the study period.
- Storage condition of test material: was stored at room temperature, without CO2, under N2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain as named in the report: SPF Wistar/Chbb: THOM
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: approximately 8-9 weeks
- Weight at study initiation: males: 260 ± 12.1 g (mean), female: 181 ± 5.7 g (mean)
- Housing: in groups of five, in cages type DK III of Becker
- Diet: KLIBA rat/mouse laboratory diet 24-343-4, 10 mm pellets, Klingenthalmuehle AG, Kaiseraugst, Switzerland, ad libitum
- Water: ad libitum (during the post-exposure observation period)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 20 (glass-steel construction, BASF AG)
- Exposure chamber volume: 55 L
- Method of holding animals in test chamber: The animals were restrained in tubes and their snouts projected into the inhalation chamber.
- Source and rate of air: 1500 L/h
- System of generating particulates/aerosols: A liquid aerosol was generated by means of a continuous infusion pump INFU 362 (INDIGEL/Switzerland) and a two-component atomizer Mod. 970 (Schlick). By means of compressed air the aerosol was generated, which was passed into the inhalation system.
- Method of particle size determination: gas chromatography
- Treatment of exhaust air: By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10 % lower (excess pressure). This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.
- Temperature in air chamber: 19 - 25 °C
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography (from the analytically determined mass values and the sample volumes of the inhalation atmosphere the concentrations were calculated in mg/L).
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gas chromatography
- Duration of exposure:
- 4 h
- Concentrations:
- - analytical: 0.28 mg/L (test group 1), 0.53 mg/L (test group 2), 0.84 mg/L (test group 3), 1.28 mg/L (test group 4), 2.85 mg/L (test group 5)
- nominal: 0.54 mg/L, 0.97 mg/L, 1.61 mg/L, 3.11 mg/L, 5.37 mg/L - No. of animals per sex per dose:
- 5
- Control animals:
- other: historical controls
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least once on each workday
- Frequency of weighing: Before the beginning of the test, after 7 days (test groups 1, 2, 4 and 5), after 8 days (test group 3) and at the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The statistical evaluation of the dose-response relationship was carried out using FORTRAN program AKPROZ.
The calculation of the particle size distribution was carried out in the Department of Toxicology of BASF AG on the basis of mathematical methods
for evaluating particle measurements (DIN 66141: Darstellung von Korngroeßenverteilungen, DIN 66161: Partikelgroeßenanalyse).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.91 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 0.73 - < 1.19
- Exp. duration:
- 4 h
- Remarks on result:
- other: Systemic toxicity (including mortality) and local irritation observed; see descriptions below for details
- Mortality:
- 0.28 mg/L: no mortalities occurred.
0.53 mg/L: 1 male died on day 2.
0.84 mg/L: 2 males and 1 female died on day 2 and a further female died until day 7.
1.28 mg/L: 2 males and all 5 females died on day 0 and a further male died on day 2.
2.86 mg/L: all animals died within 3 h of exposure. - Clinical signs:
- other: During exposure: 0.28 mg/L: initially escape attempts; irregular respiration until the end of exposure. 0.53 mg/L: initially escape attempts and accelerated respiration; whooping respiration; intermittent respiration and decreased pain reflex until the e
- Body weight:
- The body weight gain of the female rats in the test group 1, compared with a historical control collective, was not affected by the substance over the total observation period.
The body weight gain of the male rats in the test groups 1, 2, 3, compared with a historical control collective, was slightly retarded in the first week of the observation period and adjusted to normal in the second week of the observation period.
The body weight gain of the female rats in the test group 2, compared with a historical control collective, was slightly retarded in the second week of the observation period.
The body weight gain of the female rats in the test group 3, compared with a historical control collective, was reduced over the total observation period.
The body weight gain of the male animals in the test group 4, compared with a historical control collective, was reduced in the first week of the observation period and adjusted to normal in the second week of the observation period. The animals did not, however, reach the body weight which they had before exposure. - Gross pathology:
- Animals that died spontaneously:
All groups: general congestion.
0.53, 0.84, 1.28 mg/L: lungs: intensified focal hyperemia, additional moderate emphysema.
1.28 mg/L: liver: slightly marked grey brown lobules.
2.85 mg/L: lungs: intensified hyperemia with edema.
Sacrificed animal: no pathologic findings noted.
Any other information on results incl. tables
Mortality:
Dose (mg/L) | Gender | Day 0 | Day 1 | Day 2 | Day 7 | Day 14 |
0.28 | male | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
0.28 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
0.53 | male | 0/5 | 0/5 | 1/5 | 1/5 | 1/5 |
0.53 | female | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
0.84 | male | 0/5 | 0/5 | 2/5 | 2/5 | 2/5 |
0.84 | female | 0/5 | 0/5 | 1/5 | 2/5 | 2/5 |
1.28 | male | 2/5 | 2/5 | 3/5 | 3/5 | 3/5 |
1.28 | female | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 |
2.86 | male | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 |
2.86 | female | 5/5 | 5/5 | 5/5 | 5/5 | 5/5 |
Body weight:
Mean body weight (in g) | male | female | ||||
0 days | 7 days | 14 days | 0 days | 7 days | 14 days | |
0.28 mg/L | 269 | 281 | 324 | 183 | 196 | 207 |
0.53 mg/L | 265 | 274 | 314 | 181 | 194 | 201 |
0.84 mg/L | 262 | 263 | 314 | 182 | 176 | 175 |
1.28 mg/L | 257 | 194 | 226 | 179 | - | - |
2.86 mg/L | 251 | - | - | 179 | - | - |
historical control | 248 | 286 | 318 | 177 | 196 | 211 |
"-": all animals dead.
Particle size analysis:
Test group | MMAD 50% [µm] | GSD | Respirable fraction [%] |
1 | 1.6 | 3.3 | 95 |
2 | 1.5 | 3.4 | 95 |
3 | 1.7 | 3.5 | 93 |
4 | 1.4 | 3.8 | 94 |
5 | 1.8 | 3.7 | 93 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The study on acute inhalation toxicity of Di-2-ethylhexylamine as an aerosol in male and female Wistar rats resulted in a LC 50 value for both sexes of 0.91 mg/L after an exposure period of 4 hours and an observation period of 14 days. The particle size analysis revealed that the amount of respirable fraction was very high. A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 3) is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.