Registration Dossier
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EC number: 203-468-6 | CAS number: 107-15-3 EDA
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no information on GLP
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- According to Magnusson Kligman Assay
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 10%
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction 5%, Epicutaneous induction 10%, Epicutaneous challenge 10%
- No. of animals per dose:
- 10 male and 10 female
- 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
- Details on study design:
- 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. - Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Ethylenediamine is sensitising.
- Executive summary:
In a Guinea Pig Maximisation test ethylene diamine was a sensitiser. Cross sensitisation with other ethylene amine substances was observed.
Reference
Skin responses were evaluated and scored. 45% of animals tested showed signs of sensitisation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Based on the available Guinea Pig Maximisation study, with an intradermal induction of 5%, and based on moderate effects in humans a category of 1B is justified.
Migrated from Short description of key information:
Ethylenediamine is shown to be sensitising to Guinea Pigs. In a GPMT study the intradermal injection dose was 5%.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In 1999 the World Health Organization published their Concise International Chemical assessment Document 15 on 1,2 –Diaminoethane (ethylenediamine). This document referenced several case reports of respiratory senitisation apparently due to exposure to ethylene daimine but the incidence was not specified other than in one report when it was quoted to be 10%. This was a retrospective study so no challenge tests were done. Aldrich, FD, Strange AW and Geesman RE published in 1987 Smoking and ethylenediamine sensization in an industrial population, J. Occup Med 1987 Apr; 29(4) 311-314., from the abstract the incidence they was 38 out of 337 workers ca. 11%.
The paper by Lars Hagmar, MD et.al, Piperazine induced Occupational Asthma, Journal of occupational Medicine, Vol 24 No 3. March 1982, mention 2 individuals sensitized in a population of 130 workers, who had been exposed to ethylenediamine which was used until the previous year i.e. ca, 3% incidence.
In a large review paper authored by M. Chan-Yeung and J-L. Malo, Aetiological agents in occupational asthma in the Eur Resp J 194, 7 , 346-371, they reviewed about 200 agents implicated in occupational asthma. While they only included some case reports for ethylene diamine they did give percentage incidence values for some known strong respiratory sensitisers such as the diisocyanates, including TDI and HDI and some anhydrides. For these the percentage incidences were in the order of 28-35%. As we would expect these substances to be classified as 1A for respiratory sensitization we see this level of incidence being necessary to support a conclusion of high frequency. Based on this we would interpret the incidence of ca. 3-11% seen with ethylene diamine as being in the low to moderate frequency range and therefore supporting a classification of 1B. None of the admittedly limited available information supports a conclusion of 1A.
So we recommend that ethylenediamine be classified as 1B for respiratory sernsitisation based on the above information.
Migrated from Short description of key information:
Based on data from exposed workers, ethylene diamine can be considered a respiratory sensitiser.
Justification for classification or non-classification
Ethylene diamine is classified as a skin and respiratory sensitiser.
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