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EC number: 701-381-2 | CAS number: -
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment. Restriction: Report not evaluated by QAU.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Principles of method if other than guideline:
- Study according to a method of the American Society for Testing and Materials, Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals (ASTM E981). Groups of 4 male Swiss mice were exposed to 3.8, 7.7, 23 and 90 mg/m³ (0.46, 0.93, 2.79 and 10.9 ppm) Tridecylamine vapour for 45 minutes in a head-nose inhalation system. The post-exposure observation period was 7 days.
- GLP compliance:
- no
- Remarks:
- The experimental phases of this study were conducted under GLP conditions and the QAU inspected the study. However, the study report was not audited by QAU.
- Test type:
- other: Respiratory irritation
- Limit test:
- no
Test material
- Reference substance name:
- Amines, C11-C13 (linear and branched) alkyl
- EC Number:
- 701-381-2
- IUPAC Name:
- Amines, C11-C13 (linear and branched) alkyl
- Details on test material:
- - Name: Tridecylamine (CAS No. 86089-17-0)
- Degree of purity >99%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Strain: Crl:CD-1
- Age: 7-8 weeks
- Housing: singly in cages type MKI of Becker
- Environment: fully air-conditioned rooms, temperature range 20-24°C, relative humidity 30-70%, 12 hour light/dark rhythm
- Diet: standard rat/mouse/hamster laboratory diet (KLIBA 24-343-4, 10 mm pellets, from Klingentalmühle, Kaiseraugst, Switzerland) ad libitum; drinking water ad libitum
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: INA 10 (stainless steel construction, BASF AG)
- Exposure chamber volume: approx. 7.5 L
- Method of holding animals in test chamber: body plethysmographs
- Atmosphere generation: Test substance was delivered onto a heated glass vaporizer for each test group. Vapors were mixed with supply air (compressed air).
- Source and rate of air: 1200 L/h (approx. 160 air changes per hour)
TEST ATMOSPHERE
- Brief description of analytical method used: samples of test atmospheres were drawn from the inhalation system into sorbent (2-propanol) and examined using GC/FID (sample volume: 90 - 400 mL; sample frequency: 1 sample per concentration group, 2 samples for the highest concentration group)
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- by GC/FID
- Duration of exposure:
- 45 min
- Concentrations:
- 0, 3.8, 7.7, 23, and 90 mg/m³ (analytical)
- No. of animals per sex per dose:
- 4 males
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: A check for dead or moribund animals was made daily. Clinical signs were checked during and after
exposure on exposure day and once per workday during the post-exposure-observation period. The body weight of the animals was checked at random before the test and three times during the post-exposure-observation period.
- Other examinations performed:
Conduct of measurements: the test was started after the animals were placed into the plethysmographs, and was structured in 4 phases: i) adaptation phase lasting 10 min; ii) control phase lasting 15 min to establish normal breathing parameters; iii) exposure phase, lasting 45 min; recovery phase, lasting 15 min.
Respiration measurements: body plethysmographs (BASF AG) with pressure transducers were used. The signals were processed by a "Non invasive respiratory analyzer" (Buxco Electronics) as minute values and transferred to a personal computer for further evaluation using tabular calculation software.
Breathing parameters examined: respiratory rate; tidal volume; inspiration time; expiration time; relaxation time; peak expiratory flow; and minute volume.
Determination of sensory irritation, based on "ASTM: E 981-84: Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals".
Terminal examination: the animals were sacrificed at the end of the observation period. The lungs were evaluated macroscopically and weighed with trachea (without larynx). - Statistics:
- The decrease of the respiration rate was calculated (expressed as percentage depression of normal rate, RR%) for each animal by comparing the rate at an early (minutes 6 to 15 of the exposure phase), intermediate (minutes 21 to 30 of the exposure phase), and late (minutes 36 to 45 of the exposure phase) time of exposure with the normal rate (minutes 6 to 15 of the control phase). Recovery was calculated accordingly (rate at minutes 6 to 15 of the recovery phase compared to normal rate). The mean respiratory depression (RD%) for each test animal and each time interval was calculated
as 100 - RR% . These individual values were used to calculate the RD50 values. Additionally mean RD% for each test groups were calculated using the single animal RR% values.The substance concentration leading to a 50%-depression (RD50) was calculated from the logarithm of the analytical concentration and the decrease of each animal and each early, intermediate, and late time interval. The concentration and 95% confidence interval was estimated by inverse regression.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- other: RD50 early
- Effect level:
- 526 mg/m³ air
- Exp. duration:
- 45 min
- Remarks on result:
- other: Minutes 6-15 of exposure phase
- Sex:
- male
- Dose descriptor:
- other: RD50 middle
- Effect level:
- 37.4 mg/m³ air
- 95% CL:
- >= 22.2 - <= 91.6
- Exp. duration:
- 45 min
- Remarks on result:
- other: Minutes 21-30 of exposure phase
- Sex:
- male
- Dose descriptor:
- other: RD50 late
- Effect level:
- 30.4 mg/m³ air
- 95% CL:
- >= 20.4 - <= 53
- Exp. duration:
- 45 min
- Remarks on result:
- other: Minutes 36-45 of exposure phase
- Mortality:
- No mortalities observed.
- Clinical signs:
- other: Clinical signs were only seen in test group 3 (23 mg/m³; piloerection in 4 animals, reduced general state of one animal until days 6 and 7 of the observation period) and in test group 4 (90 mg/m³; piloerection in 4/4 animals, dragging respiration in 4/4 a
- Body weight:
- Body weights were decreased in the high dose test group from day 1 until day 7 post exposure, without reaching the p<0.05 level of statistical significance.
- Gross pathology:
- Focal red discoloration in some lobes of the lung was found in 2/4 high dose animals. No abnormalities were detected in the other animals.
- Other findings:
- - Organ weights: on day 7 post exposure the absolute lung weights were decreased in the test groups 3 and 4 without reaching the p<0.05 level of statistical significance whereas the lung weights of the animals at 3.8 and 7.7 mg/m³ were comparable to controls. The relative lung weights were comparable in all animal groups.
- Respiratory depression: The time response curves showed a concentration dependent steady decrease of breathing rate throughout the exposure period, with only minimal indication of reversal during the recovery period. Thus, the RD50s calculated from respiration rates measured early, in the middle and late during the exposure period were steadily decreasing. The RD50 was lowest with a value of about 30 mg/m³ ≈ 4 ppm during the last third of the exposure period.
Any other information on results incl. tables
Respiration rate decrease (group means, 4 animals per group):
Test group |
Analytical concentration (mg/m³) |
Respiration rate decrease (RD%) |
|||
early |
middle |
late |
recovery |
||
0 |
Control |
11.6 |
10.8 |
12.3 |
6.6 |
1 |
3.8 |
27.1 |
20.8 |
23.7 |
30.2 |
2 |
7.7 |
34.6 |
35.0 |
36.0 |
39.5 |
3 |
23 |
26.5 |
36.9 |
45.7 |
28.7 |
4 |
90 |
45.7 |
63.9 |
63.0 |
63.5 |
RD50 values and lower (LCL) and upper (UCL) 95% confidence limits:
RD50 (mg/m³) |
LCL |
UCL |
RD50 (ppm) |
|
early |
526 |
no meaningful result |
no meaningful result |
63.7 |
middle |
37.4 |
22.2 |
91.6 |
4.53 |
late |
30.4 |
20.4 |
53.0 |
3.68 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test substance effects mainly pulmonary irritation in mice. The RD50 is steadily decreasing and is lowest with a value of about 30 mg/m³ ≈ 4 ppm during the last third of the exposure period. Exposure of mice to 23 or 90 mg/m³ for a period of 45 minutes caused clinical signs during exposure (piloerection and depressed breathing rate during exposure). Poor general state and reduced body weights were seen in animals exposed to 90 mg/m³.
Pathology revealed focal red discoloration in some lobes of the lung in 2/4 high dose animals. Although no changes in lung weights occurred (possibly due to measurement only after 7 days post exposure), the macroscopic lung findings and the time-response relationship of breathing rates suggest that significant pulmonary irritation was present.
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