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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: weight of evidence of supporting substance (structural analogue)
- Adequacy of study:
- weight of evidence
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no information on GLP
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- According to Magnusson Kligman Assay
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study conducted in 1997 by Leung et al. based on former standards. The study was conducted before the Local Lymph Node Assay was accepted as a OECD TG (first in 2002).
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Dunkin Hartley Haz:(DH)fBR albino guinea pigs
- Source: HRP Inc. (Denver, PA).
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 278-444 gr) - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 5%
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 5%
- No. of animals per dose:
- 10 male and 10 female
- Details on study design:
- The maximization procedure involved the induction of an immunologically based sensitization process by injection of the test material into the skin (intradermal induction) followed by application of test material on the skin at the challenge site. Any of the observations greater than that seen in the irritation control animals was considered an allergic response.
Groups of 10 male and 10 female guinea pigs each received 0.1 mL intradermal induction injections into 2 sites each of the clipped shoulder skin as follows: 50% (v/v) Freund's complete adjuvant (FCA) water emulsion, the test material or vehicle, and the test material in FCA/water emulsion or FCA/water emulsion. Epicutaneous inductions were conducted 7 days later. The test material was applied to a 2 x 4 cm filter paper, which was then placed on the test site and secured with tape. The patches were left in place for 48 h, after which they were removed and the skin wiped free of any excess test material.
Epicutaneous challenge was undertaken by applying 2 x 2 cm filter paper squares soaked in the ethylenediamine solution to a previously untreated site (right flank) 14 days after epicutaneous induction (i.e., 21 days from the start of the study). Patches were left in place for 24 h, and the sites inspected for signs of irritation 24-48 h after removal of the occlusive dressings.
In general, scores of 1 or greater were considered clearly indicative of sensitization. Scores of 0.5 were considered equivocal, although a high percentage of 0.5 scores with no response in irritation control animals would be considered suggestive of sensitization. The percentage of animals reacting, rather than the intensity of reactions, was the criterion for assessing sensitization potency.
Grading scale used for evaluation of skin responses:
Score 0: No reaction
Score 0.5: Very slight (barely perceptible) erythema, usually nonconfluent
Score 1: Slight (well-defined) erythema
Score 2: Moderate erythema
Score 3: Severe erythema, with or without edema, necrosis, or eschar formation - Challenge controls:
- Irritation control animals, five male and five female guinea pigs, received the same challenge procedures as in the definitive sensitization study, but did not have preceding intradermal and/or epicutaneous induction procedures
- Positive control substance(s):
- no
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 2 448
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- 45% in the group (n = 20) showed a positive skin response with score equal or greater than 1 at readings 24-48h after removal of the occlusive dressings.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st and 2nd reading. . Hours after challenge: 2448.0. Group: test group. Dose level: 5%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: 45% in the group (n = 20) showed a positive skin response with score equal or greater than 1 at readings 24-48h after removal of the occlusive dressings..
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Ethylenediamine was tested in the Guinea Pig Maximization Test according to the method described by Magnusson and Kligman (Leung, H.W. et al., 1997) in Dunkin-Hartley guinea pig (10 males and 10 females per dose). The maximization procedure involved the induction of an immunologically based sensitization process by injection of the test material into the skin (intradermal induction) followed by application of test material on the skin at the challenge site. Control animals (5 males and 5 females) received the same challenge procedures as in the definitive sensitization study, but did not have subsequent intradermal and/or epicutaneous induction procedures. Any of the observations greater than that seen in the control animals was considered an allergic response. Skin responses were evaluated and scored. In general, scores of 1 or greater were considered clearly indicative of sensitization. Scores of 0.5 were considered equivocal, although a high percentage of 0.5 scores with no response in irritation control animals would be considered suggestive of sensitization. The percentage of animals reacting, rather than the intensity of reactions, was the criterion for assessing sensitization potency. 45% of animals tested showed signs of sensitisation. Based on the facts that ethylenediamine was found to be a skin sensitizer and has also been reported to cross-sensitize for chemicals of similar structure (same publication, Leung, H.W. et al., 1997) and trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group), trimethylenediamine is assumed to be also a skin sensitizer.
Migrated from Short description of key information:
Based on the facts that ethylenediamine is reported as skin and as cross-sensitizer for chemicals of similar structure and trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group), trimethylenediamine is assumed to be a skin sensitizer.
Justification for selection of skin sensitisation endpoint:
A reliable read across study.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Trimethylenediamine is structural very similar to ethylenediamine (difference: chain length / one CH2-group). Therefore, the conclusions drawn, are sufficient for read across and assessment of the toxicity of trimethylenediamine.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- experience in humans with ethylenediamine (CAS# 107-15-3)
- GLP compliance:
- no
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Route of induction exposure:
- inhalation
- Route of challenge exposure:
- inhalation
- Results:
- According to the evaluations reported in "OECD SIDS Ethylenediamine CASN°: 107-15 -3" (2003), there are rare reports on cases of occupational sensitization in production facilities induced by ethylenediamine. Delayed-type asthma and occasionally dual-type asthma has been observed but no cases of immediate-type asthma were reported. Also the relationship between allergy symptoms and smoking practice on respiratory sensitization to ethylenediamine has been studied in employees of a manufacturing plant in USA. A subset of 38 individuals of 337 was identified by clinical and work history as having become sensitized to ethylenediamine showing symptoms like rhinitis, coughing and expiratory wheezing which cleared after removal from ethylenediamine work environment. Based on this information ethylenediamine is found to be a respiratory sensitizer in humans. Since trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group), it is assumed to be a respiratory sensitizer in humans.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
According to the evaluations reported in "OECD SIDS Ethylenediamine CASN°: 107-15 -3" (2003), there are rare reports on cases of occupational sensitization in production facilities induced by ethylenediamine. Delayed-type asthma and occasionally dual-type asthma has been observed but no cases of immediate-type asthma were reported. Also the relationship between allergy symptoms and smoking practice on respiratory sensitization to ethylenediamine has been studied in employees of a manufacturing plant in USA. A subset of 38 individuals of 337 was identified by clinical and work history as having become sensitized to ethylenediamine showing symptoms like rhinitis, coughing and expiratory wheezing which cleared after removal from ethylenediamine work environment. Based on this information ethylenediamine is found to be a respiratory sensitizer in humans. Since trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group), it is assumed to be also a respiratory sensitizer in humans. However, no quantitative data were found regarding levels of ethylenediamine that cause respiratory sensitization in exposed workers.
Migrated from Short description of key information:
Based on the facts that ethylenediamine is reported as respiratory sensitizer and as cross-sensitizer for chemicals of similar structure and trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group), trimethylenediamine is assumed to be a respiratory sensitizer.
Justification for selection of respiratory sensitisation endpoint:
Most reliable read across study.
Justification for classification or non-classification
Based on read across to a Magnusson Kligman Assay performed with ethylenediamine and to observation in workers when exposed to ethylenediamine, the test substance has to be classified with respect to skin and respiratory sensitisation with
- "R 42/43 May cause sensitization by inhalation and skin contact" according to Directive 67/548/EEC (DSD) and
- "H317 May cause an allergic skin reaction" and "H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled" according to Regulation (EC) No 1272/2008 (CLP, GHS).
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.