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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
Endpoint summary
Administrative data
Description of key information
Acute Toxicity:
- oral: LD50: 1008 mg/kg bw (rat; BASF AG 1967)
- dermal: LD50: 956 mg/kg bw (rabbit; Union Carbide 1968)
- inhalation: LC50: 0.91 mg/L air (rat; BASF AG 1991)
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:
- 05. Jun 1967 - 14. Jun 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented report which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (adopted 1981)
- Deviations:
- yes
- Remarks:
- (7 day observation period; highest dose tested was 1612 mg, but all animals of this dose group - besides one male animal - died)
- Principles of method if other than guideline:
- BASF-Test. The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: US-rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: male: 254 g (mean), female: 206 g (mean). - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous Traganth solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2% (161 mg/kg bw), 20% (806, 1008, 1290, 1612 mg/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 6.25 ml (1250 mg/kg bw), 5 ml (1000 mg/kg bw), 8 ml (1600 mg/kg bw), 10 ml (200 / 2000 mg/kg bw) - Doses:
- 161, 806, 1008, 1290, 1612 mg/kg bw (= 200, 1000, 1250, 1600, 2000 mL/kg bw ; calculation of doses in mg/kg bw by means of density = 0.8062 g/mL)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 008 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Systemic toxicity (including mortality) and local irritation observed; see descritpions below for details
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 149 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 847 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Females appeared to be more sensitive.
- Mortality:
- 1612 mg/kg bw: 1 male died within 24 h. 3 males and 5 females died within 48 h. 4 males died within 7 days. 1 male animal survived.
1290 mg/kg bw: 1 male and 3 females died within 24 h. 2 males and 4 females died within 48 h. 5 males and 5 females died within 7 days.
1008 mg/kg bw: 2 females died within 24 h. 5 females died within 48 h. All males survived.
806 mg/kg bw: 1 female died within 7 days. All other animals survived.
161 mg/kg bw: No animal died. - Clinical signs:
- other: 1612 – 806 mg/kg bw: Irregular / accelerated respiration, heavy ruffled fur, anogenital region smeared with feces (diarrhea), squatting posture, apathy, red eye and nose crusts. The survivors recovered. 161 mg/kg bw: Same but less distinct symptoms as in
- Gross pathology:
- dead animals (806 - 1612 mg/kg bw): Dilated stomach in 18 cases, atony in 8 cases, and blood smeared snouts.
sacrificed animals: Uneven faded liver, adhesion between liver, stomach, spleen and left kidney; bronchitis, bronchopneumonia with emphysema. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The study on acute oral toxicity of Di-2-ethylhexylamin in male and female US-rats resulted in a LD50 value for both sexes of 1008 mg/kg bw. The female animals appeared to be more sensitive. A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 4) is required.
Reference
Mortality
Dose (mg/kg bw) | Gender | 1 h | 24 h | 48 h | 7 days | ||
1612 | male | 0/5 | 1/5 | 3/5 | 4/5 | ||
female | 0/5 | 0/5 | 5/5 | 5/5 | |||
1290 | male | 0/5 | 1/5 | 2/5 | 5/5 | ||
female | 0/5 | 3/5 | 4/5 | 5/5 | |||
1008 | male | 0/5 | 0/5 | 0/5 | 0/5 | ||
female | 0/5 | 2/5 | 5/5 | 5/5 | |||
806 | male | 0/5 | 0/5 | 0/5 | 0/5 | ||
female | 0/5 | 0/5 | 0/5 | 1/5 | |||
161 | male | 0/5 | 0/5 | 0/5 | 0/5 | ||
female | 0/5 | 0/5 | 0/5 | 0/5 |
The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 008 mg/kg bw
- Quality of whole database:
- Available data is reliable and sufficient for assessment.
Acute toxicity: via inhalation route
Link to relevant study records
- 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
- 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
- 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 - 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). - 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. - 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 910 mg/m³ air
- Quality of whole database:
- Available data is reliable and suffidcient for assessment.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary source.
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
- Test type:
- other: no data
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 956 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: = 1190 µL/kg bw (calculation of the dose in mg/kg bw by means of the density at 20°C: 0.803 g/cm³)
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The study on acute dermal toxicity of bis(2-ethylhexyl)amine in rabbits resulted in a LD50 value of 956 mg/kg bw. No further information given. A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 3) is required.
- Executive summary:
A dermal LD50 value of 1.19 mL/kg, equivalent to 956 mg/kg bw, was reported for rabbits, with no further details, because data were only available as secondary quotation cited in RTECS updates 9504 and 199709 (Union Carbide 1968; reliability score 4).
Reference
Of pronounced toxicity after a short term skin contact.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 956 mg/kg bw
- Quality of whole database:
- Only secondary source, but two routes are covered and additionally, the test substance is corrosive. Therefore, it is assumed that the available data is sufficient for assessment.
Additional information
Oral:
In an acute oral toxicity study (BASF AG 1967; reliability score 2) groups of US rats (5 / sex) were given a single oral dose (via gavage) of the test substance in aqueous Traganth solution at doses of 200, 1000, 1250, 1600, 2000 mg/kg bw and observed for 7 days.
Oral LD50Males = ca. 1149 mg/kg
Oral LD50Females = ca. 847 mg/kg bw
Oral LD50Combined = ca. 1008 mg/kg bw
The female animals appeared to be more sensitive. Main clinical signs observed were irregular / accelerated respiration, heavy ruffled fur, anogenital region smeared with feces (diarrhea), squatting posture, apathy, red eye and nose crusts. All survivors recovered. At necropsy of the dead animals, dilated stomach, atony and blood smeared snouts were observed. The sacrificed animals showed uneven faded liver, adhesion between liver, stomach, spleen and left kidney; bronchitis or bronchopneumonia with emphysema.
In a range finding toxicity publication of Smyth et al., groups of 5 rats (gender unspecified) received 4 dosages in geometrical series, with a ratio 2 between successive dose levels, and were observed for 14 days; a LD50 of 1640 mg/kg bw (Smyth et al. 1949; reliability score 2).
Dermal:
A dermal LD50 value of 1.19 mL/kg, equivalent to 956 mg/kg bw was reported for rabbits, with no further details provided, because data were only available as secondary quotation cited in RTECS updates 9504 and 199709 (Union Carbide 1968; reliability score 4).
According to REACH Regulation Annex VIII, 8.5 acute toxicity studies does not need to be conducted if the substance is classified as corrosive and in addition to the oral route informations according to acute toxicity shall be provided for at least one other route, respectively. Informations concerning acute toxicity via oral and inhalative route are provided. Additionally, the test substance is classified as corrosive. Therefore, it is concluded that the available information is sufficient and no further acute dermal toxicity study is necessary.
Inhalation:
Acute inhalation toxicity was analyzed in study performed according to OECD Guideline 403 (BASF AG 1991; reliability score 2).Groups of young adultWistar rats (5/sex) were dosed with the test substance as aerosol at concentrations of 0.28 mg/L, 0.53 mg/L, 0.84 mg/L, 1.28 mg/L or 2.85 mg/L for 4 hours (nose/head only). Animals then were observed for 14 days.
LC50Combined = 0.91 mg/L (95% C.I..: 0.73 – 1.19 mg/L)
Main clinical signs observed were local irritation of the airways and of the eyes. 30 min post application tonic-clonic convulsions, restlessness, pain reflex and intermittent respiration were noted. Also effects on body weight were noted. At necropsy, general congestion and pulmonary hyperemia with edema were observed.
Additional data were available from inhalation risk tests (IRT). The inhalation of a saturated vapour-air mixture (0.2 mg/L) for 8 h caused no mortality in male and female rats (strain not specified). Symptoms described included signs of irritation of the mucous membranes and post mortem examination revealed occasional bronchopneumonia (BASF AG 1967; reliability score 2).
In a second IRT, groups of six male albino rats (strain unspecified) were exposed to a flowing stream of air substantially saturated with vapours of the test material. No mortality was observed (Smyth et al. 1949; reliability score 2).
Due to the results of the inhalation studies there is evidence that the test substance is strongly irritating, at high concentrations corrosive, to the respiratory system. Additionally, a study was conducted to characterize the respiratory irritation potential caused by the test substance qualitatively and quantitatively (calculation of RD50; BASF AG 1998; reliability score 2). Groups of 4 male Swiss mice were placed individually in whole body plethysmographs connected to a head-nose inhalation system. After an adaption phase of ten minutes and a control phase of 15 minutes, the animals were exposed to analytically determined concentrations of 7.88, 32.6 and 48.6 mg/m3(0.8, 3.3 and 4.8 ppm) test substance vapours for 45 minutes. The exposure phase was followed by a recovery phase of 15 minutes. A post exposure observation period lasting 7 days was also included in the study. Respiratory parameters were measured in each animal during control, exposure and recovery period and the RD50was calculated.A considerable decrease of RD50value occurred with prolongation of exposure. In each concentration used, the respiratory depression was not reversible during the recovery phase. No clinical signs and no abnormalities were detected during necropsy. No changes of lung weights occurred in the exposed animals as compared to control. It was concluded that the test substance led mainly to pulmonary irritation.
Justification for selection of acute toxicity – oral endpoint
Key study
Justification for selection of acute toxicity – inhalation endpoint
Key study
Justification for selection of acute toxicity – dermal endpoint
Only one study available without detailed information.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The reliable oral toxicity studies led to classification according to Regulation (EC) No.1272/2008 (EU-GHS: Cat. 4).
Regarding the results of the dermal test classification according to Regulation (EC) No.1272/2008 (EU-GHS: Cat. 3) is required.
Due to the reliable results of the inhalation studies classification according to Regulation (EC) No.1272/2008 (EU-GHS: Cat.3) is required.
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