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EC number: 251-974-0 | CAS number: 34375-28-5
- 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
The skin sensitization potential of 2-[hydroxy(methyl)amino]ethanol(34375-28-5) was estimatedby SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances. 2-[hydroxy(methyl)amino]ethanol(34375-28-5)was predicted to be sensitizing to the skin of female Pirbright-Hartley 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 version.3.3 and QMRF report has been attached.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3 with logKow as the primary descriptor.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 6-9 weeks
- Weight at study initiation: 344-485 g
- Housing: single housing makrolon cage, type III
- Diet: standard diet ad libitum (ALTROMIN(R) Nr. 3022 from Altromin, Lage, Germany)
- Water: ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 55 +/- 15 %
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: Intrademal 30 %Epidermal: paste (0.5 g test substance with 0.4 ml physiol.
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50%
- Day(s)/duration:
- 48 hour
- No. of animals per dose:
- control group: 10
test group: 20 - Details on study design:
- MAIN STUDYA. I
NDUCTION EXPOSURE
Intradermal
- No. of exposures: 6 (2 x test substance, 2 x test substance / FCA (1:1), 2x FCA)
- Exposure period: Day 1
- Test groups: test group: see above
- Control group: same treatment, but vehicle instead of test substance
- Site: shoulder region
- Frequency of applications: once on day 1
- Duration: single exposure, next exposure on day 8
- Concentrations: 30 %Epidermal
- No. of exposures: 1
- Exposure period: Day 8-
Test groups: occlusive patch with test substance: paste (0.5 g test substance with 0.4 ml physiol. saline)
- Control group: same treatment, but vehicle instead of test substance
- Site: shoulder region
- Frequency of applications: once on day 8
- Duration: 48 h
- Concentrations: paste (0.5 g test substance with 0.4 ml physiol. saline)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 22, day 23
- Exposure period: 24 h
- Test groups: right flank (vehicle), left flank (test substance)
- Control group: same as test group- Site: flank
- Concentrations: 50 %
- Evaluation (hr after challenge): 48 hrs after last challenge - Challenge controls:
- yes
- Positive control substance(s):
- no
- Statistics:
- No data available.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- Skin sensitization effect were observed.
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: Sensitizing .
- Conclusions:
- The skin sensitization potential of 2-[hydroxy(methyl)amino]ethanol(34375-28-5) 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. 2-[hydroxy(methyl)amino]ethanol(34375-28-5)was predicted to be sensitizing to the skin of female Pirbright-Hartley guinea pig.
- Executive summary:
The skin sensitization potential of 2-[hydroxy(methyl)amino]ethanol(34375-28-5) was estimatedby SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances. 2-[hydroxy(methyl)amino]ethanol(34375-28-5)was predicted to be sensitizing to the skin of female Pirbright-Hartley guinea pig.
Reference
The
prediction was based on dataset comprised from the following
descriptors: "S M W N"
Estimation method: Takes highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((("a"
or "b" or "c" or "d" )
and ("e"
and (
not "f")
)
)
and "g" )
and "h" )
and ("i"
and "j" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Alcohol OR N-Hydroxylamine
derivatives by Organic Functional groups ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Alcohol OR N-Hydroxylamine
derivatives OR Overlapping groups by Organic Functional groups (nested)
ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] OR
Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Amino, aliphatic
attach [-N<] OR Hydroxy, aliphatic attach [-OH] OR Hydroxy, nitrogen
attach [-OH] OR Oxygen, nitrogen attach [-O-] by Organic functional
groups (US EPA) ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Alcohol OR Hydroxy compound OR
Hydroxylamine OR Primary alcohol by Organic functional groups, Norbert
Haider (checkmol) ONLY
Domain
logical expression index: "e"
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: "f"
Referential
boundary: The
target chemical should be classified as Alkylalkanol-amines by Skin
irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "h"
Similarity
boundary:Target:
CN(O)CCO
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "i"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -4.16
Domain
logical expression index: "j"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 3.8
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization
In different studies, 2-[hydroxy(methyl)amino]ethanol(34375-28-5)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 and human for target chemical2-[hydroxy(methyl)amino]ethanol(34375-28-5) .The predicted data using the OECD QSAR toolbox has also been compared with the experimental data of target chemical.
The skin sensitization potential of 2-[hydroxy(methyl)amino]ethanol(34375-28-5) was estimatedby SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and considering the six closest read across substances. 2-[hydroxy(methyl)amino]ethanol(34375-28-5)was predicted to be sensitizing to the skin of female Pirbright-Hartley guinea pig.
It is supported by experimental study conducted by SHIRO TANAKA et al.(Contact Dermatitis, 1984) to evaluate the skin sensitizing potential of target substance 2-[hydroxyl (methyl)amino] ethanol (34375-28-5) in Human. Skin sensitization test for 2[(hydroxymethyl)amino]ethanol (34375-28-5) was assessed for its possible contact allergenic potential .For this purpose11 paperhangers (ages from 31 to 59; median 49 years old) were patch tested for the additives, 2-[(hydroxymethyl)amino ]ethanol and polyethylene glycol monolauroyl ester. They were observed for skin reactions after 48 and 72hours. The test material was patch tested at concentration of 5%.When pretested on 6 control subjects, these patch test solutions produced negative reactions. 2-[(hydroxymethyl) amino ] ethanol was the most allergenic to the patients after 72 hours observationIt can be concluded that2[(hydroxymethyl)amino]ethanol (34375-28-5)is a strong skin sensitizer in human .
Thus based on the above predictions on 2-[hydroxy(methyl)amino]ethanol(34375-28-5)andapplying weight of evidence, it can be concluded that2-[hydroxy(methyl)amino]ethanol is a strong skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 2-[hydroxy(methyl)amino]ethanol(34375-28-5)can be considered as “classified” for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus comparing the above annotations with the criteria of CLP regulation, 2-[hydroxy(methyl)amino]ethanol(34375-28-5)can be considered as “classified” for skin sensitization.
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