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EC number: 230-053-7 | CAS number: 6928-85-4
- 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
The skin sensitization potential of4-Methylpiperazin-1-amine (6928-85-4)was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances4-Methylpiperazin-1-amine was predicted to be not sensitizing to the skin of female Crl:HA guinea pig.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- 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 from OECD QSAR toolbox v3.3 and the QMRF report has been attached.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Prediction was done using OECD QSAR toolbox v3.3, 2017
- GLP compliance:
- not specified
- Type of study:
- other: not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 4-Methylpiperazin-1-amine
- Molecular formula: C5H13N3
- Molecular weight: 115.179 g/mol
- Substance type: organic
- Physical state: Liquid
- Smiles notation: N1(CCN(CC1)C)N
- InChl: 1S/C5H13N3/c1-7-2-4-8(6)5-3-7/h2-6H2,1H3 - Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
- No. of animals per dose:
- Total:30
test group:20
Control group:10 - Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Statistics:
- No data available
- Positive control results:
- No data available
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin sensitization reaction was noted
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitising
- Conclusions:
- The skin sensitization potential of 4-Methylpiperazin-1-amine (6928-85-4) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances 4-Methylpiperazin-1-amine was predicted to be not sensitizing to the skin of female Crl:HA guinea pig.
- Executive summary:
The skin sensitization potential of 4-Methylpiperazin-1-amine (6928-85-4) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances4-Methylpiperazin-1-amine was predicted to be not sensitizing to the skin of female Crl:HA guinea pig.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "Skin Sensitisation"
Estimation method: Takes highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((((((((("a"
or "b" or "c" )
and "d" )
and ("e"
and (
not "f")
)
)
and ("g"
and (
not "h")
)
)
and "i" )
and ("j"
and (
not "k")
)
)
and ("l"
and (
not "m")
)
)
and ("n"
and (
not "o")
)
)
and ("p"
and (
not "q")
)
)
and ("r"
and (
not "s")
)
)
and ("t"
and "u" )
)
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 Radical OR Radical >> Radical
mechanism via ROS formation (indirect) OR Radical >> Radical mechanism
via ROS formation (indirect) >> Hydrazine Derivatives by DNA binding by
OASIS v.1.3 ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as SN1 OR SN1 >> Iminium Ion
Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
by DNA binding by OECD ONLY
Domain
logical expression index: "d"
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 ONLY
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Non binder, impaired OH or NH2
group OR Non binder, MW>500 OR Non binder, non cyclic structure OR
Strong binder, OH group by Estrogen Receptor Binding
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.3
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Carbamates OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >>
Ester aminolysis >> Dithiocarbamates OR Acylation >> Ring opening
acylation OR Acylation >> Ring opening acylation >> beta-Lactams OR SN2
OR SN2 >> Nucleophilic substitution at sp3 carbon atom OR SN2 >>
Nucleophilic substitution at sp3 carbon atom >> Sulfonates OR SN2 >> SN2
Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction at a sp3 carbon
atom >> Activated alkyl esters and thioesters by Protein binding by
OASIS v1.3
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD ONLY
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg AND (!Undefined)Group CN Lipid Solubility < 0.4
g/kg by Eye irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group CNHal Lipid
Solubility < 400 g/kg OR Group All Aqueous Solubility < 0.00002 g/L OR
Group All log Kow < -3.1 OR Group All Melting Point > 200 C OR Group CN
Aqueous Solubility < 0.1 g/L OR Group CN log Kow > 4.5 OR Group CN
Molecular Weight > 290 g/mol OR Group CNHal Aqueous Solubility < 0.1 g/L
OR Group CNS Aqueous Solubility < 0.006 g/l OR Group CNS log Kow > 1.5
OR Group CNS Melting Point > 200 C OR Group CNS Melting Point > 50 C by
Eye irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg AND (!Undefined)Group CN Lipid Solubility < 0.4
g/kg by Skin irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Group CN Vapour Pressure < 0.001
Pa by Skin irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Inclusion rules not met by Skin
irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Ketones OR Tertiary aliphatic
amine by Skin irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Group 14 - Carbon C AND Group 15
- Nitrogen N by Chemical elements
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Group 14 - Metalloids Si,Ge OR
Group 16 - Oxygen O by Chemical elements
Domain
logical expression index: "r"
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 Hydrazine [>N-N<] by Organic functional
groups (US EPA)
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as Amino, aliphatic attach [-NH-]
OR Amino, aliphatic attach [-NH2] OR Aromatic Nitrogen, five-member ring
OR Azomethine, aliphatic attach [-N=C] OR Nitrogen, two or tree olefinic
attach [>N-] OR Olefinic carbon [=CH- or =C<] OR Olefinic carbon [=CH2]
by Organic functional groups (US EPA)
Domain
logical expression index: "t"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -2.15
Domain
logical expression index: "u"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 1.89
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In different studies, 4-Methylpiperazin-1-amine (6928-85-4) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in guinea pig for target chemical, 4-Methylpiperazin-1-amine (6928-85-4) and its structurally similar read across substancesTriethylenediamine(280-57-9)and N-Methyldiethanolamine (105-59-9) the predicted data using the OECD QSAR toolbox has also been compared with the experimental data of read across.
The skin sensitization potential of 4-Methylpiperazin-1-amine (6928-85-4) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances4-Methylpiperazin-1-amine was predicted to be not sensitizing to the skin of female Crl:HA guinea pig.
The experimental study conducted by OECD HPV SIDS (OECD HPV Chemical Programme, SIDS Dossier approved at SIAM 21, 2005) to evaluate the skin sensitizing potential of read across substanceTriethylenediamine(280-57-9). The skin sensitization study of Triethylenediamine(280-57-9)was performed by Guinea pig maximisation test in 20 Male and female Dunkin-Hartley albino guinea pigs. An additional 10 animals served as the vehicle control group; a positive control group was not included in the study.In induction phase,1stinduction given using 0.1concentration in physiological saline by intradermal route while in 2ndinduction done by using 25% concentration by epidermal application. In challenge phase, test substance 10 % concentration in same vehicle used for first and second challenge dose. No skin sensitizing reaction observed after challenge application.2 Female showed emaciation at day 36 and37. One Female showed emaciation from day 36 to 39 of test. While 2 female showed diarrhea at day 37.The body weight gain of the animals was not affected during the test with the exception of 3 animal, 2 female died spontaneously at day 37 of the test study. No macroscopic findings were observed at necropsy for these animals had reddened abdominal wall, reddened diaphragm, and fluid in the myocardium were observed. Hence it is considered that Triethylenediamine(280-57-9)was not skin sensitizing in guinea pig by Guinea pig maximisation test.
It is further supported by experimental study conducted by European Commission – European Chemicals Bureau(IUCLID Dataset-European Chemicals Bureau- 18–FEB–2000) to evaluate the skin sensitizing potential of read across substance N Methyldiethanolamine ( 105-59-9)The skin sensitization study of N Methyldiethanolamine was carried out in 20 guinea pigs by guinea pig maximization test. During induction animals were first induced intradermal with 5% test material in propylene glycol and dermally with 100%.following induction challenge was performed .since results at Challenge were equivocal a Re–Challenge was performed in the same manner as the Challenge, but at concentrations of 50% and 10% N–methyldiethanolamine. In order to differentiate dermal reactions produced by irritation from those produced by sensitization, 20 animals (5/sex/Challenge; treated concurrently during Induction with only vehicle or FCA/water emulsion) were subjected to the same Challenge or Re Challenge procedures as the animals which received test material during the Induction exposures. Fourteen days after the last induction exposure, the Challenge treatment was administered topically at 100%. Eighteen of the 20 animals challenged with 100% N–methyldiethanolamine exhibited clear dermal responses. Index of Sensitization at Challenge to N–methyldiethanolamine was 90%. The Severity Indices at Challenge for the test material group at 24 and 48 hours are 0.8 and 1.8, respectively, compared to 0.8 and 1.6, respectively, for the irritation control group (out of a maximum Index of 3.0). Due to the responses seen in the irritation controls, a Re–Challenge was performed at lower, less irritating concentrations. Animals were re–challenged with both 50% and 10% N–methyldiethanolamine at separate sites. Dermal evaluations were made approximately 24 and 48 hours after the removal of Challenge/Re–Challenge patches. It was observed that the test animals treated with re-challenged dose 50% and 10% N–methyldiethanolamine were free of dermal responses. The Severity indices at Re–Challenge at 24 and 48 hours were both 0.0 for both the test group and the irritation control group. Hence the test chemical N-Methyldiethanolamine (CAS No: 105-59-9) can be considered as non-sensitizing to guinea pigs at 50% and 10% concentration.
Thus based on the above predictions on4-Methylpiperazin-1-amine (6928-85-4) as well as its read across and applying weight of evidence, it can be concluded that 4-Methylpiperazin-1-amine (6928-85-4) is not a skin sensitizer. Thus comparing the above studies with the criteria of CLP regulation, 4-Methylpiperazin-1-amine (6928-85-4) can be considered as not classified for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus comparing the above studies with the criteria of CLP regulation, 4-Methylpiperazin-1-amine (6928-85-4) can be considered as not classified for skin sensitization.
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