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EC number: 220-666-8 | CAS number: 2855-13-2
- 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:
- 1983-09-19 - 1983-10-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no positive control group (not required by 1981 version of guideline)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no positive control group (not required by 1981 version of guideline)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1981 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- 3-aminomethyl-3,5,5-trimethylcyclohexylamine
- EC Number:
- 220-666-8
- EC Name:
- 3-aminomethyl-3,5,5-trimethylcyclohexylamine
- Cas Number:
- 2855-13-2
- Molecular formula:
- C10H22N2
- IUPAC Name:
- 3-aminomethyl-3,5,5-trimethylcyclohexylamine
- Details on test material:
- Isophorone diamine of Hüls AG, purity >= 99.7 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley (Bor: DHPW)
- Source: Winkelmann, Borchen (Germany)
- Weight at study initiation: 363 g (mean)
- Housing: 1-5 animals in Makrolon cages type IV
- Diet: ad libitum, special diet for guinea pigs, SSniff G 4 (Ssniff, Soest, Germany)
- Water: ad libitum, tab water
- Acclimation period: 5-8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 1 °C
- Humidity: 60 +/- 5 %
- Photoperiod: 12 hours artificial light, 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intracutaneous (1st) and occlusive epicutaneous (2nd)
- Vehicle:
- other: 10 % ethanol
- Concentration / amount:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 7.5 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 10 % ethanol
- Concentration / amount:
- 1st application: Induction 0.1 % intracutaneous
2nd application: Induction 7.5 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous
- No. of animals per dose:
- 9 (10) control group, 1 animal died after 1 week, cause of death is unkwon
20 test group - Details on study design:
- - Induction schedule: injection followed 1 week later by patch treatment (0.3 ml) for 48 hours;
- Injection details: 0.1 ml each at 6 positions on shoulders:
2 x Freund's Complete Adjuvant
2 x 0,1% test substance in 10 % ethanol
2 x Freund's Complete Adjuvant / 0.2 % test substance (1:1)
simultaneous and symmetrical application of each solution
controls: 10 % ethanol instead of test substance
- Challenge schedule: 2 weeks after end of induction patch treatment for 24 hours
- Concentrations used for challenge: 2.5 and 5 %; readings 24, 48, and 72 hours after removal of patch
- Rechallenge: no
EXAMINATIONS
- Grading system: possible scores 0 / 1 / 2 / 3
- Pilot study: dose range finding study - Challenge controls:
- 9 (10) animals, 1 animal died after 1 week, cause of death is unkwon
vehicle treatment - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5 %. No with. + reactions: 7.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5 %. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2.5%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 2.5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 2.5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 18.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 15.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5 %. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 5% test substance used for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- see section "Remarks on results including tables and figures"
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 5% test substance used for challenge. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: see section "Remarks on results including tables and figures".
Any other information on results incl. tables
Local effects:
- 24 hours after intracutaneous applications, animals mainly from the test substance treated group displayed poorly healing necrotic inflammations.
- After the induction patch treatment for 48 hours, the animals treated with the test substance had bleeding and matter discharging inflammations at the places of injections leading to thick crusts.
- In general after removal of the patch, severe inflammation and itching were observed, causing particularly the animals treated with test substance to scratch their skins open in the area of injection.
- after challenge scale formation and desiccation of skin was observed during the observation period on some animals
Applicant's summary and conclusion
- Conclusions:
- Isophorone diamine has to be considered to be sensitizing to the skin of guinea pigs under the conditions of the study.
- Executive summary:
The skin sensitizing properties of isophorone diamine were determined in a guinea pig maximation test according to OECD TG 406 (positive controls not required by 1981 guideline version). Twenty male guinea pigs were intradermally injected with isophorone diamine at 0.1 % in 10% ethanol and one week later epidermally exposed to a 7.5 % concentration of test substance for 48 hours (occlusive). Ten control animals were similary treated, but with vehicle alone. Two weeks after the epidermal application all animals were challegend with 2.5 % and 5 % test substance and with vehicle (24 hours occlusive). At challenge concentration of 2.5 % 7/20 animals showed a sensitization 24 hours after the patch test, 5/20 animals 48 hours after the test and 2/20 72 hours after the test. At challenge concentration 5 % 18/20 animals showed a sensitization 24 hours after the patch test, 15/20 animals 48 hours after the patch test and still 10/20 72 hours after the test. No animal of the control group showed any positive reaction. Therefore, Isophorone diamine has to be considered to be sensitizing to the skin of guinea pigs under the conditions of the study.
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