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EC number: 225-730-9 | CAS number: 5036-48-6
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL (90d oral, rat) / [sRV * time] *absorption oral/absorption inhal. * no/light work
= NOAEL / [0.8 L/min/kg bw rat * 8*60 min] *50%/100% * 6.7m3/10m3
= 300 mg/kg bw/d /0.384 m3/kg /2 *0.67 = 261.7 mg/m3- AF for dose response relationship:
- 1
- Justification:
- The NOAEL of 300 mg/kg bw/d is the mid-dose of a GLP compliant OECD408 study.
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default after correction to NOAEC by route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- Study according to GLP and OECD TG guideline
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Worst case: oral = dermal absorption --> dermal NOAEL = 1 * oral NOAEL
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL of 200 mg/kg bw/d is the mid-dose of a GLP OECD407 study.
- AF for differences in duration of exposure:
- 2
- Justification:
- default for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance: rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- EACH REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guidline studies
- AF for remaining uncertainties:
- 1
- Justification:
- EACH REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General considerations
As N-(3-Aminopropyl)-imidazol, CAS 5036-48-6 (API) is classified as Skin Corr. 1B, H314 (CLP EU), it should be attributed to a moderate hazard class according to the Guidance on information requirements and chemical safety assessment, Part E - Risk Characterisation, E.3.4 (ECHA, May 2008). Appropriate RMMs (risk management measures) and OCs (operational conditions) should therefore be implemented, when developing exposure scenarios.
The primary route of anticipated occupational exposure to API is via skin contact. Given its low vapour pressure at room temperature (0.12 Pa), inhalation of API vapour is not likely to be high. As API is used as an additive in polymerization processes, spraying uses can occur. However, the exposition to aerosols or droplets of an inhalable size is rather unlikely due to the operational conditions and risk management measures, protecting against the corrosivity.
Concerning acute toxicity API is moderate toxic after single ingestion (LD50 (oral, rat) > 1780 mg/kg bw). According to the REACh regulation, annex VIII, 8.5 column 2, inhalation or dermal study does not need to be conducted due to the corrosivity of API to the skin. Furthermore, according to the REACh regulation, annex VII+VIII, 8.2 and annex VII, 8.3, column 2 neither an eye irritation / corrosion study nor a skin sensitization study was performed due to the corrosivity.
DNEL derivation: Point of departure
The starting point for the systemic long term inhalation and dermal DNEL is a NOAEL of 300 mg/kg bw/d, obtained by Wistar rats from an oral 90-d study (OECD TG 408 with exposure via gavage; 2019; RL1). The local irritation of the mucosa of the stomach/forestomach in the high dose group (1000 mg/kg bw/d) was considered to be the main effect of the test substance. This might be the reason for the general systemic toxicity (clinical findings, decrased BW gain and grip strength of hindlimbs in males, decrased MA measurements). However, incrased liver weights in the high dose females were also observed and some changes in clinical chemistry (lower total protein, albumin and globulin levels in males and females, higher urea levels in males and higher triglyceride levels in females) indicated a dysregulation of the liver cells.
Supportingly, the NOAEL in an oral 28 -d study was 200 mg/kg bw (OECD407, 1999; RL1) and the maternal NOAEL in an oral OECD414 was 300 mg/kg bw/d (2019; RL1). The developmental NOAEL of this OECD414 study was 1000 mg/kg bw/d. No adverse effects of API were found in an oral OECD421 stud y (2012; RL1) up to the highest dose tested (1000 mg/kg bw).
No local (long term or acute/short term) DNELs and no systemic short term DNELs were derived, because API is classified as Skin Corr. 1B, H314 (GHS EU) and dose-response information is not available (Guidance on information requirements and chemical safety assessment, Part R.8 - Characterisation of dose [concentration]-response for human health; ECHA, v 2.1, November 2012).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
There are no consumer uses known for API. Thus, no DNELs for the general population were derived.
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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