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EC number: 203-406-8 | CAS number: 106-52-5
- 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
Repeated
dose toxicity: oral
The
No Observed Adverse Effect Level (NOAEL) for the test compound
1-Methyl-4-hydroxypiperidine for rats was estimated to be 1029 mg/kg
bw/day (nominal).
Repeated
dose toxicity: inhalation
A short term toxicity does not needs to be conducted because exposures of humans via inhalation in production and/or use is not likely as based on provided thorough and rigorous exposure assessment (exposure considerations).
Repeated
dose toxicity: dermal
The
acute toxicity value for 1-methylpiperidin-4-ol (as provided in section
7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical;
repeated exposure by the dermal route is unlikely since the use of
gloves is common practice in industries. Thus, it is expected that
1-methylpiperidin-4-ol shall not exhibit 28 day repeated dose toxicity
by the dermal route. In addition, there is no data available that
suggests that 1-methylpiperidin-4-ol shall exhibit repeated dose
toxicity by the dermal route. Hence this end point was considered for
waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Data is predicted using OECD QSAR toolbox version 3.4 and the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 1-methylpiperidin-4-ol
- Molecular formula: C6H13NO
- Molecular weight: 115.175 g/mol
- Substance type: Organic
- Physical state: Liquid - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- No data
- Remarks:
- Doses / Concentrations:
No data
Basis: - No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- No data
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 029 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: Estimated
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound 1-Methyl-4-hydroxypiperidine for rats was estimated to be 1029 mg/kg bw/day (nominal).
- Executive summary:
Repeated dose toxicity study was performed for the test chemical 1-Methyl-4-hydroxypiperidine using SSS QSAR prediction database, 2016. The study assumed the use of rats in a subacute study. The No Observed Adverse Effect Level (NOAEL) for the test compound 1-Methyl-4-hydroxypiperidine is found to be 1029 mg/kg bw/day (nominal).
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and "j" )
and ("k"
and (
not "l")
)
)
and ("m"
and "n" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Aliphatic Amines by US-EPA New
Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Alcohol AND Piperidine AND
Saturated heterocyclic amine AND Saturated heterocyclic fragment by
Organic Functional groups
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Alcohol AND Overlapping groups
AND Piperidine AND Saturated heterocyclic amine AND Saturated
heterocyclic fragment by Organic Functional groups (nested)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] AND
Aliphatic Carbon [-CH2-] AND Aliphatic Carbon [-CH3] AND Amino,
aliphatic attach [-N<] AND Hydroxy, aliphatic attach [-OH] by Organic
functional groups (US EPA)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Alcohol AND Amine AND
Heterocyclic compound AND Hydroxy compound AND Secondary alcohol AND
Tertiary aliphatic amine AND Tertiary amine by Organic functional
groups, Norbert Haider (checkmol)
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.4
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as AN2 OR AN2 >> Michael-type
addition, quinoid structures OR AN2 >> Michael-type addition, quinoid
structures >> Quinones and Trihydroxybenzenes OR Non-covalent
interaction OR Non-covalent interaction >> DNA intercalation OR
Non-covalent interaction >> DNA intercalation >> Amino Anthraquinones OR
Non-covalent interaction >> DNA intercalation >> Quinones and
Trihydroxybenzenes OR Radical OR Radical >> Radical mechanism via ROS
formation (indirect) OR Radical >> Radical mechanism via ROS formation
(indirect) >> Amino Anthraquinones OR Radical >> Radical mechanism via
ROS formation (indirect) >> Quinones and Trihydroxybenzenes OR SN1 OR
SN1 >> Nucleophilic attack after metabolic nitrenium ion formation OR
SN1 >> Nucleophilic attack after metabolic nitrenium ion formation >>
Amino Anthraquinones OR SN2 OR SN2 >> Alkylation OR SN2 >> Alkylation >>
Alkylphosphates, Alkylthiophosphates and Alkylphosphonates by DNA
binding by OASIS v.1.4
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Iminium Ion
Formation AND SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
by DNA binding by OECD
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Michael addition OR Michael
addition >> Polarised Alkenes-Michael addition OR Michael addition >>
Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated esters OR
No alert found by DNA binding by OECD
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Non-Metals by Groups of elements
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Alkali Earth OR Alkaline Earth
OR Metalloids OR Transition Metals by Groups of elements
Domain
logical expression index: "m"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -4.16
Domain
logical expression index: "n"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.9
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 029 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is from K2 prediction database
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Additional information
Repeated dose toxicity: Oral
Prediction model based estimation and data from read across have been summarized to determine the toxic nature of the test compound 1-Methyl-4-hydroxypiperidin upon repeated application by oral route of exposure:
Repeated dose toxicity study was performed for the test chemical 1-Methyl-4-hydroxypiperidine (CAS NO 106 -52 -5) using SSS QSAR prediction database, 2016. The study assumed the use of rats in a subacute study. The No Observed Adverse Effect Level (NOAEL) for the test compound 1-Methyl-4-hydroxypiperidine is found to be 1029 mg/kg bw/day (nominal).
In a study for Read across chemical, Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) was performed to evaluate the toxic nature of the test compound1-Methylpiperazine (RA CAS no 109 -01 -3) upon repeated dosing by oral route (J check, 2016). The test was performed onmale and femaleCrl:CD (SD) rats at dose levels of 0, 80, 200, 500 mg/kg/day. The animals were observed for clinical signs, body weight, food consumption, urinalysis, hematological and blood biochemistry parameters, gross and histopathological changes. On the basis of observations made, The No Observed Adverse effect level (NOAEL) for the test compound 1-Methylpiperazine is found to be 80 mg/Kg bw/day in male and female Crl:CD (SD) rats.
The weight of evidence data summarized suggests the chemical 1-Methyl-4-hydroxypiperidine to be not likely classified for repeated dose toxicity by oral route of administration.
Repeated
dose toxicity: inhalation
A
short term toxicity does not needs to be conducted because exposures of
humans via inhalation in production and/or use is not likely as based on
provided thorough and rigorous exposure assessment (exposure
considerations).
Repeated
dose toxicity: dermal
The
acute toxicity value for 1-methylpiperidin-4-ol (as provided in section
7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical;
repeated exposure by the dermal route is unlikely since the use of
gloves is common practice in industries. Thus, it is expected that
1-methylpiperidin-4-ol shall not exhibit 28 day repeated dose toxicity
by the dermal route. In addition, there is no data available that
suggests that 1-methylpiperidin-4-ol shall exhibit repeated dose
toxicity by the dermal route. Hence this end point was considered for
waiver.
Justification for classification or non-classification
The weight of evidence data summarized suggests the chemical 1-Methyl-4-hydroxypiperidine to be not likely classified for repeated dose toxicity by oral route of administration.
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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