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EC number: 203-842-9 | CAS number: 111-18-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb - Mar 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981-05-12)
- Deviations:
- yes
- Remarks:
- (number of animals in test and control group smaller than recommendations in guideline (12 vs. 20), no data of positive controls given)
- Principles of method if other than guideline:
- Test procedure was conducted according to Magnusson and Kligmann (Magnusson, B. and Kligman A.M.: The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J. Invest. Dermatol. 52, 268 – 276 (1969))
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Equivalent study of good quality from 1982 is available, additional conduct of LLNA is not deemed scientifically justified.
Test material
- Reference substance name:
- N,N,N',N'-tetramethylhexamethylenediamine
- EC Number:
- 203-842-9
- EC Name:
- N,N,N',N'-tetramethylhexamethylenediamine
- Cas Number:
- 111-18-2
- Molecular formula:
- C10H24N2
- IUPAC Name:
- [6-(dimethylamino)hexyl]dimethylamine
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N,N',N'-Tetramethyl-1,6-hexanediamine
- Analytical purity: 97.5 %
- Expiration date of the lot/batch: 1984-01 (on account of the sufficient stability no analytical evidence of the stability was necessary during the study)
- Impurities (identity and concentrations): N,N',N'-Trimethyl-1,6-hexanediamine 2 %
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 235 - 310 g
- Housing: 6 animals per cage (Type IV Makrolon cage)
- Diet: SSNIFF GK 4 mm, standard diet for rabbits and guinea pigs, Ssniff Versuchstierdiäten GmbH, Soest, Germany
- Water (e.g. ad libitum): ad libitum (fully demineralized from monday to friday, tap water on saturdays and sundays; about 2 g ascorbic acid/ 10 L water was added to the drinking water twice per week)
- Acclimation period: at least 7 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): 25 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- pretest: 0.5, 1, 3, 5, 10 % in aquous solution
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % in aquous solution
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5 % in aqueous solution
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 3 % in aqueous solution
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 3 % in aqueous solution
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 6 (control group 1 and 2)
12 (test group) - Details on study design:
- RANGE FINDING TESTS:
Amount applied: 0.15 g of test substance preparation occlusive (by filter strips soaked with a 0.5mm layer of the test substance)
Preparations of the test substance: 0.5, 1, 3, 5, 10 % in aqua dest
Exposure period: 24 hrs
Number of animals: 4/ test concentration
Readings: 24 and 48 hrs after application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal), after 7 days epicutaneous application (48 hrs)
Intradermal iinjection:
- Site: shoulder region
- Frequency of application: once
- Test groups:
3 pairs of injections
1.) 1:1 mixture (Freund's adjuvant/ water)
2.) test substance preparation (5%)
3.) mixture of Freund's adjuvant/water (1:1) and test substance preparation (5%)
- Control group (2 identical control groups)
3 pairs of injections
1.) 1:1 mixture (Freund's adjuvant/ water)
2.) aqua dest
3.) mixture of Freund's adjuvant/water (1:1) and aqua dest
Epicutaneous application: test substance 5% in aqua dest. (controls were not applied), occlusiv
- Site: shoulder region (same region as with intradermal injection)
- Frequency of applications: once, 7 days after intradermal injection
- Duration: 48 hrs
- Concentrations: 5% test substance in aqua dest. (0.3 g test substance preparation using 2x4 cm test filter paper strip)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge:
1.) First challenge:
14 days after epicutanous application
2.) Rechallenge:
about one week after first challenge
- Exposure period: 24 hrs for challenge and rechallenge
- Test groups: test substance in aqua dest.
- Control group: 1st control group: test substance in aqua dest (3%), 2 nd control group: aqua dest
- Site: right flank (1st challenge), left flank(2nd challenge)
- Concentrations: 3%
- Evaluation (hr after challenge): 24, 48, 72
Assessment of Skin findings:
1. Erythema and eschar formation:
a) No erythema: 0
b) Very slight erythema (barely perceptible): 1
c) Well-defined erythema: 2
d) Moderate to severe erythema: 3
e) Severe erythema (beet redness) to slight eschar
formation (injuries in depth): 4
2. Edema formation:
a) No edema: 0
b) Very slight edema (barely perceptible): 1
c) Slight edema (edges of area weil defined by definite raising): 2
d) Moderate edema (raised approximately 1 mm): 3
e) Severe edema (raised more than 1 mm and extending beyond the area of exposure: 4
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3 % (first control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 % (first control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only (second control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no application since distilled water was used as vehicle
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle only (second control group). No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no application since distilled water was used as vehicle.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only (second control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no application since distilled water was used as vehicle
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle only (second control group). No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no application since distilled water was used as vehicle.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3 % (first control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 % (first control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3 % (second control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3 % (second control group)
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no observations
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
A test on substance N,N,N',N'-Tetramethyl-1,6-hexanediamine was conducted for assessing the skin sensitization potential of the compound. The test was conducted according to the method of Magnusson and Kligmann which was comparable to the OECD guideline study 406 (1981) with deviations (no data of positive control, smaller number of test and control animals; 12 vs. 20).
The substance was applied on female guinea pigs with 2 groups of negative control (6 animals per group) and one test group (12 animals). For induction, a 5 % solution of test substance with water was injected intradermally and after 7 days applied epicutaneously. Then a first challenge 14 d after percutanous application and a 2nd challenge one week later was done with control and test substance (3 % in aqua dest.). No positive results were obtained for the test substance -neither in the challenge nor in the rechallenge application. Consequently the substance is to be considered as non-sensitizing in the Magnusson-Kligman-Test under the test conditions chosen.
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