Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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

Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: published study results; acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
- Principles of method if other than guideline:
- see Test sections "Test materials", "Test animals" and "Administration/exposure"
- GLP compliance:
- not specified
- Limit test:
- no
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
- Reference substance name:
- Isophorone diamine
- IUPAC Name:
- Isophorone diamine
- Details on test material:
- Isophorone diamine; purity not reported
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- details not reported
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Remarks:
- aerosol/vapour atmosphere
- Remarks on MMAD:
- MMAD / GSD: no data
- Details on inhalation exposure:
- - Concentrations (substance concentrations in aerosol/vapour atmosphere): 18 (low dose group) / 200 (medium dose group) / 550 mg/m3 (high dose group)
- Doses: 9 inhalation nose-only exposures for 6 hours per day in low and medium dose groups; exposure of high dose group ended after 4 nose-onl y exposures due to unexpected mortality of 4 rats - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- low and medium dose group: 9 exposures (1 exposure/day; 6hours/day )
high dose group: 4 exposures (1 exposure/day; 6hours/day) - Frequency of treatment:
- each group: 1exposure /day (6hours/day)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/m³ air
- Remarks:
- control group
- Dose / conc.:
- 18 mg/m³ air
- Remarks:
- low dose group
- Dose / conc.:
- 200 mg/m³ air
- Remarks:
- intermediate dose group
- Dose / conc.:
- 550 mg/m³ air
- Remarks:
- high dose group
- No. of animals per sex per dose:
- 10
- Control animals:
- other: use of control rats reported but no specific information provided
- Details on study design:
- - Concentrations (substance concentrations in aerosol/vapour atmosphere): 18 (low dose group) / 200 (medium dose group) / 550 mg/m3 (high dose group)
Low and medium dose groups (10 male rats/group):
- Doses: 9 inhalation nose-only exposures for 6 hours per day in low and medium dose groups;
- end of exposure period: 5 rats/dose group were sacrified for pathological examinations after collection of blood and urine samples and the remaini g 5 rats/dose group undergone a 20 day recovery period. After 20 day recovery period the rats were used for pathology examinations
High dose group (10 male rats/group):
- exposure of high dose group ended after 4 nose-only exposures (6 hours/day) due to unexpected mortality of 4 rats
- remaining 6 rats were killed and necropsied one day after fourth exposure - Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- Daily examinations during exposure period:
- weighing of rats
- observation for clinical signs of toxicity - Sacrifice and pathology:
- Sacrifice:
- no detailed information available: see "Details on study design"
Pathology:
- microscopic examination of nose, trachea, larynx and lungs - Other examinations:
- not reported
- Statistics:
- not reported
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1 during 3rd exposure, 2 during 4th exposure and 1 after 4th exposure in high dose group
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weight and mean body weight gain: significantly reduced in high dose group during period of exposure
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose and compound-related microscopic alterations were observed in the nose, trachea, larynx and lungs of the rats in the medium dose group (200 mg/m3) and in the high dose group (550 mg/m3) and only in the nose of rats of the low dose group (18 mg/m3). In all dose groups after exposure period these alterations were in general characterized by necrosis but also repair (hypertrophy and hyperplasia) was evident at tis time. Lungs and trachea of rats of the low (18 mg/m3) and medium (200 mg/m3) dose group were normal at the end of recovery period (20 days) and tissue repair was still in progress in nose and larynx in these dose groups
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: 1 during 3rd exposure, 2 during 4th exposure and 1 after 4th exposure in high dose group
- Mean body weight and mean body weight gain: significantly reduced in high dose group during period of exposure
-Respiratory system: dose and compound-related microscopic alterations were observed in the nose, trachea, larynx and lungs of the rats in the med ium dose group (200 mg/m3) and in the high dose group (550 mg/m3) and only in the nose of rats of the low dose group (18 mg/m3). In all dose g roups after exposure period these alterations were in general characterized by necrosis but also repair (hypertrophy and hyperplasia) was evident at tis time. Lungs and trachea of rats of the low (18 mg/m3) and medium (200 mg/m3) dose group were normal at the end of recovery period (20 da ys) and tissue repair was still in progress in nose and larynx in these dose groups. Hence the authors expect close to full microscopic restitution.
Effect levels
- Dose descriptor:
- LOEC
- Effect level:
- 18 mg/m³ air
- Sex:
- male
- Basis for effect level:
- other: substance releated effects in the nose (considered to be reversible)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
no further information
Applicant's summary and conclusion
- Conclusions:
- The substance isophorone diamine was examined in an inhalation repeated toxicity study (nose-only) using male rats (10/dosage group) exposed to aerosol/vapour concentrations of 18, 200, and 550 mg/m³ (6 hours/day for 9 exposures with low and medium dose groups and for 4 exposures with the high dose group). Dose-dependent histopathology was identified in the respiratory tract. A NOEL was not reported in the published study information. The LOEC is 18 mg/m3 air.
- Executive summary:
The substance isophorone diamine was examined in an inhalation repeated toxicity study (nose-only) using male rats (10/dosage group) exposed to aerosol/vapour concentrations of 18, 200, and 550 mg/m³ (6 hours/day for 9 exposures with low and medium dose groups and for 4 exposures with the high dose group). Treatment with 550 mg/m³ was associated with mortality, significantly reduced mean body weights and significantly reduced mean body weight gains. Dose-dependent histopathology was identified in the respiratory tract. In the low and medium dose groups these microscopic alterations in the respiratory tract are considered to be reversible. A NOEL was not reported in the published study information. The LOEC is 18 mg/m3 air.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
