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EC number: 211-541-9 | CAS number: 660-68-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2000-2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientific publication that meets basic documentation requirements. No data on positive control substance(s).
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparison of dose–responses of contact allergens using the guinea pig maximization test and the local lymph node assay
- Author:
- Francois M.M. van Och, Rob J. Vandebriel, Menk K. Prinsen, Wim H. De Jong, Wout Slob, Henk van Loveren
- Year:
- 2 001
- Bibliographic source:
- Toxicology 167: 207-215
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals per group
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Diethylamine
- EC Number:
- 203-716-3
- EC Name:
- Diethylamine
- Cas Number:
- 109-89-7
- Molecular formula:
- C4H11N
- IUPAC Name:
- N-ethylethanamine
- Test material form:
- other: free base solution
- Details on test material:
- DEA (diethylamine; 99.5%; free base solution;
Sigma-Aldrich Chemie B.V., Zwijndrecht, The
Netherlands),
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR
- Sex:
- male
- Details on test animals and environmental conditions:
- The experiments were conducted according to the maximization test method as described by Magnusson and Kligman (1969 and 1970), and according to OECD guideline no. 406 (OECD, 1992) and EC guideline B.6 (1992). Approximately 3-wk-old, male SPF-outbred albino guinea pigs (Crl:(HA)BR) with a body weight range of 175–300 g, were purchased from Charles River (Wiga, Sulzfeld, Germany). They were housed in groups of no more than 10 in a mobile battery (IFFA CREDO, Someren, The Netherlands), containing four cages with internal dimensions of 967×512×250 mm in a temperature- and humidity-controlled animal room with a 12-h light/dark cycle. Water and food (SDS Special Diets Services, Witham, UK) were provided ad libitum.
The animals were kept in quarantaine for at least 1 week before the start of the study. During this period the health status was checked by clinical observation and serological examinations.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- intradermal: 0.3 - 0.01%; epicutaneous: 10.0 - 0.3%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 30, 10, 3%
- No. of animals per dose:
- 5 per group
- Details on study design:
- RANGE FINDING TESTS:
The irritation response to intradermal injection of various concentrations of the test substance (3, 1, 0.3 and 0.1%) was examined in three guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1 mL of the selected concentrations were applied by intradermal injection. Approximately 24 h after injection, the animals were examined for signs of irritation.
MAIN STUDY
Briefly, the maximization test consists of two induction treatments, namely intradermally and topically, followed by a resting period of 14 days,which precedes the challenge treatments. Between induction treatments, a 7-day interval was employed. For the induction phase, dose response studies were performed with a fixed ratio of 33 of concentrations between the intradermal and topical administration.
A. INDUCTION EXPOSURE
- No. of exposures: intradermal + topical
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site:
- Frequency of applications: 2
- Duration: 24 h
- Concentrations: 0.3 + 10, 0.1 + 3, 0.03 + 1, 0.01 + 0.3
B. CHALLENGE EXPOSURE
- No. of exposures: 3 test material concentrations + 1 control
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 h
- Test groups: 4
- Control group: 1
- Site:
- Concentrations: 30%, 10 %, 3%
- Evaluation (hr after challenge) 24, 48 h after removal of patches - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%+10% induction, 30 % challenge
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%+3% induction, 30 % challenge
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.03%+1% induction, 30 % challenge
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01%+0.3% induction, 30 % challenge
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% induction, 30 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%+10% induction, 30 % challenge
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%+1% induction, 30 % challenge
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.03%+1% induction, 30 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01%+0.3% induction, 30 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% induction, 30 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%+10% induction, 10 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%+3% induction, 10 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.03%+1% induction, 10 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01%+0.3% induction, 10 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% induction, 10 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%+10% induction, 10 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%+3% induction, 10 % challenge
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.03%+1% induction, 10 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01%+0.3% induction, 10 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% induction, 10 % challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- CLP: Skin Sens. Cat. 1, H317
Diethylamine was evaluated using a dose response analysis for the GPMT with a multiple dose design. The test material was positive in this assay.
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