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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
Endpoint summary
Administrative data
Description of key information
skin sensitisation (OECD 406, RL2) males guinea pigs, GPMT: sensitising
RA from diethylamine (CAS 109-89-7)
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:
- 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).
- 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.
- 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. - Route:
- intradermal and epicutaneous
- Vehicle:
- maize oil
- Concentration / amount:
- intradermal: 0.3 - 0.01%; epicutaneous: 10.0 - 0.3%
- 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
- 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
- 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. - Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- refer to the analogue approach justification document provided in section 13
- Reason / purpose for cross-reference:
- read-across source
- 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
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.01%+0.3% induction, 10 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
- 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
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% induction, 10 % challenge. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- CLP: Skin Sens. Cat. 1, H317
Applying the RA approach, similar results are expected for the target substance.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to diethylammonium chloride, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
The available data on skin sensitisation of the source substance (diethylamine) meet the criteria for classification according to
Regulation (EC) 1272/2008 as Skin Sens. Cat 1 (H317). Applying the RA-A approach, similar results are expected for the target substance diethylammonium chloride.
No data on respiratory sensitisation are available.
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.
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