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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-702-7 | CAS number: 109-76-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Oral: The acute oral LD50 was determined to be 311 mg/kg bw in rats.
Dermal: The acute dermal LD50 was determined to be 178 mg/kg bw in rabbits.
Inhalation: No mortality was detected when rats were exposed to a saturated atmosphere of the test substance for 8 hours. The concentration of the test material in saturated atmosphere was calculated to be 14165 mg/m3.
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:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 90 - 120 grams
- Fasting period before study: no
- Rockland rat diet - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- The dosages were arranged in a logarithmic series differing by a factor of two.
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- 14-day post observation period
- Statistics:
- Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson* using the tables of Weil**.
*Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 11: 115 (June 1947).
**Weil, C. S.: Tables for Convenient Calculation of median-Effective Dose (LD50 or ED50) and Instruction in Their Use. Biometrics 8: 249 (Sep 1952) - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 311 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 196 - <= 507
- Mortality:
- Only LD 50 value of 0.35 mL/kg bw (corr. to 311 mg/kg bw) was reported
- Clinical signs:
- other: no data
- Gross pathology:
- no data
- Other findings:
- no data
Reference
Details of toxic effects not reported other than lethal dose value. Result in publication is given as 0.35 mL/kg. Density used by the registrant for conversion: 0.89 g/mL
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 311 mg/kg bw
- Quality of whole database:
- No GLP, but scientifically well documented studies
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 8 h
- Concentrations:
- Substantially saturated vapour atmospheres were generated dynamically.
Concentrations are not specified. - No. of animals per sex per dose:
- Number: 6
Sex not specified. - Control animals:
- not specified
- Details on study design:
- Concentrated vapour was generated in a gas washing bottle by passing died air at 2.5 L/min through a fritted glass disc immersed to a depth of at least 1-1/2 inches in the chemical which was delivered to rats in a 9L glass exposure chamber. Mean vapour concentration was calculated from the loss in weight of the liquid or estimated from the vapour pressure at the actual temperature of the chemical during aeration.
- Preliminary study:
- The saturated vapour, dynamically generated at 23 degree C is calculated to be equivalent to 4600 ppm.
Basis for the calculation was the vapour pressure of 4.66 hPa at 22.9 degree C as described in IUCLID section 4.
Based on a conversion factor for the vaporized test substance published by GESTIS* (1 ppm = 1 mL/m3 = 3.08 mg/m3), the inhaled concentration is calculated to be 14165 mg/m3.
*http://www.dguv.de/ifa/de/gestis/stoffdb/index.jsp - Sex:
- not specified
- Dose descriptor:
- LC0
- Effect level:
- > 4 600 ppm
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Remarks on result:
- other: No mortality occurred in 6/6 rats exposed to a substantially saturated vapour, dynamically generated at 23 degree C. Based on conversion (1 ppm = 3.08 mg/m3), the inhaled concentration is equivalent to 14165 mg/m3.
- Mortality:
- None
- Clinical signs:
- other: Redness of extremities within 3 h. Wet fur within 1.5 h.
- Gross pathology:
- No remarkable findings.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 14 165 mg/m³ air
- Quality of whole database:
- No GLP, but scientifically well documented studies
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data are given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- other: Modified Draize test
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg - Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- The fur of the male albino New Zealand rabbits was removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.
The animals were immobilized during the 24-hours contact period, after which the film is removed and the rabbits are caged for the subsequent 14-Day observation period. - Duration of exposure:
- 24 h
- Doses:
- no data
- No. of animals per sex per dose:
- 4 males
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson* using the tables of Weil**.
*Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 11: 115 (June 1947).
**Weil, C. S.: Tables for Convenient Calculation of median-Effective Dose (LD50 or ED50) and Instruction in Their Use. Biometrics 8: 249 (Sep 1952) - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 178 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 0.13 - <= 0.24
Reference
Details of toxic effects not reported other than lethal dose value.
Result in publication is given as 0.2 mL/kg (0.15 - 0.27 mL/kg ).
Density used by the registrant for conversion: 0.89 g/mL
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 178 mg/kg bw
- Quality of whole database:
- No GLP, but scientifically well documented studies
Additional information
Oral:
The lowest LD50 was found in an acute oral toxicity study (Smyth, H.F. et al., 1962) where groups of five male Carworth-Wistar rats were exposed to Triethylenediamine by single oral doses (gastric intubation). Animals then were observed for 14 days. The identified LD50 value was 0.35 mL/kg bw, corresponding to 311 mg/kg bw (95% CL: >= 196 to <= 507 mg/kg). This study is classified as acceptable key study. The other available study results on oral acute toxicity reveal higher LD50 values:
- 500 mg/kg bw [Source: Encyclopaedia of Chemical Technology" (Spitz, R.D. , 1962)]
- 548 mg/kg bw (95% CL: >= 0.340 to <= 0.883 mg/kg bw), calculated from the published data of 0.616 mL/kg (95% CL: >= 0.382 to <= 0.992 mL/kg). [Source: NTIS/OTS (1991), also cited by Myers and Ballantyne (1997)]
- ca. 707 mg/kg bw (BASF, 1966).
Dermal:
In an acute dermal toxicity study (Smyth et al., 1962, also reported by RTECS, 2011) the penetration of rabbit skin by the test substance was examined in groups of four male albino New Zealand rabbits that were occlusively exposed for 24 hours and then observed for 14 days.
The identified LD50 value was 0.2 mL/kg bw, corresponding to 178 mg/kg bw.
This finding is supported by several studies (also under occlusive conditions) resulting in LD50 values of
- 356 mg/kg bw (95% confidence interval: equal/higher 218 and equal/lower 581 mg/kg bw), NTIS/OTS (1991), also reported by Myers and Ballantyne (1997), and
- ca. 200 mg/kg bw (BASF, 1979).
Inhalation:
In an acute inhalation toxicity study (NTIS/OTS, 1991), no mortality occurred in 6 rats exposed for 8h to a substantially saturated vapour, dynamicallly generated at 23 degree C (some skin irritation noted; 14 -day observation period).Based on conversion (1 ppm = 3.08 mg/m3), the inhaled concentration is equivalent to 14165 mg/m3.
The same or identical results were reported by Myers and Ballantyne (1997) and Smyth et al. (1962).
Two further studies (BASF, 1966) support the findings in the key study: 12 rats were exposed by inhalation to a vapour-air mixture of the test substance at 20 degrees centigrade at 8300 mg/m3 for 1h and at 1950 mg/m3 for 8h exposure. In both studies, none of 12 animals died.
Other routes:
LD50 (i.p.) values of about 57 mg /kg bw (7 days post observation period) and about 53 mg /kg bw (14 days post observation period) were derived from an unpublished study in mouse (BASF, 1966).
A LD50 (i.p.) in mouse of 296 mg/kg bw is cited by RTECS. The original bibliographic source is Yakugaku Zasshi, a journal of pharmacy (1977).
Justification for selection of acute toxicity – oral endpoint
Most reliable study.
Justification for selection of acute toxicity – inhalation endpoint
Most reliable study.
Justification for selection of acute toxicity – dermal endpoint
Most reliable study
Justification for classification or non-classification
Acute oral toxicity
Based on a LD50 of 311 mg/kg bw, the test substance trimethylenediamine has to be classified Xn, R22 "Harmful if swallowed" according to Commission Directive 2001/59/EC and as acute oral cat. 4 (H302, "Harmful if swallowed") according to Regulation (EC) No 1272/2008 (CLP).
Acute inhalation toxicity
In an acute inhalation study the LC0 was found to be greater than 14165 mg/m3 for the test substance as no mortality occured at test conditions. Based on this data, trimethylenediamine is not liable for classification and labelling for inhalation toxicity according to Regulation (EC) No 1271/2008 (CLP) or Directive 67/548/EC (DSD) criteria.
Acute dermal toxicity
In an acute dermal toxicity study the LC50 was found to be 178 mg/kg bw. Based on this data, trimethylenediamine has to be classified T, R24 "Toxic in contact with the skin" according to Commission Directive 2001/59/EC and as acute dermal cat. 2 (H310, "Fatal in contact with skin") according to Regulation (EC) No 1272/2008 (CLP).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)