Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer revieved journal.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Dermatitis in paperhangers
- Author:
- SHIRO TANAKA AND JAMES B. LUCAS
- Year:
- 1 984
- Bibliographic source:
- Contact Dermatitis, Volume 10, Issue 1, page 54, January 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- 2-[hydroxy(methyl)amino]ethanol /(34375-28-5) was evaluated for its skin sensitizing potential.Skin sensitisation test performed on human by using patch test.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Not specified .
Test material
- Reference substance name:
- 2-(hydroxymethylamino)ethanol
- EC Number:
- 251-974-0
- EC Name:
- 2-(hydroxymethylamino)ethanol
- Cas Number:
- 34375-28-5
- Molecular formula:
- C3H9NO2
- IUPAC Name:
- 2-[hydroxy(methyl)amino]ethanol
- Details on test material:
- - Name of test material: Ethanol, 2-(hydroxymethylamino)
- Molecular formula: C3-H9-N-O2
- Molecular weight: 91.1091 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): 2[(hydroxymethyl)amino]ethanol
Molecular formula (if other than submission substance): C3H9NO2
Molecular weight (if other than submission substance): 91.1091
Substance type: Organic
Physical state: Liquid
In vivo test system
Test animals
- Species:
- human
- Strain:
- other:
- Remarks:
- Not applicable.
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
Source: members of the paperhanger's union in New York City.
Age at study initiation: ages from 31 to 59; median49 years old
Weight at study initiation: Not mentioned
Housing: Not mentioned
Diet (e.g. ad libitum): Not mentioned
Water (e.g. ad libitum): Not mentioned
Acclimation period: Not mentioned
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous solution
Challenge
- Route:
- other: Not performed
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous solution
- No. of animals per dose:
- 11 male humans
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
No. of exposures: Single
Exposure period: 72 hours
Test groups: 11 volunteers
Control group: 6
Site: hands
Frequency of applications:
Duration:72 hours
Concentrations: 5%
B. CHALLENGE EXPOSURE
No. of exposures: Not mentioned
Day(s) of challenge: Not mentioned
Exposure period: Not mentioned
Test groups: 11
Control group: 6
Site: Not mentioned
Concentrations: 5 %
Evaluation (hr after challenge): 48 and 72 hour
OTHER:
Full-time paperhangers have continuous exposure to the paste and its chemical additives which may cause allergic contact dermatitis. The manufacturer of pastes used by these paperhangers reported that the paste was made of water, starch, refined clay, vinyl acetate and chemical additives like chloromethoxy propyl mercuric acetate, 2-[(hydroxymethyl)amino ]ethanol and polyethylene glycol monolauroyl ester. - Challenge controls:
- Pretested on 6 control
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available.
Results and discussion
- Positive control results:
- When pretested on 6 control subjects, these patch test solutions produced negative reactions
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% aqueous solution (v/v) of the test chemical
- No. with + reactions:
- 11
- Total no. in group:
- 11
- Clinical observations:
- Not mentioned
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
When pretested on 6 control subjects, these patch test solutions produced negative reactions.
Patch test results for 2-[(hydroxymethyl)amino ]ethanol
Chemical name |
Test solution |
Patients results (72 h) |
|||||
2-[(hydroxymethyl)amino ]ethanol |
5% |
1 |
2 |
3 |
4 |
5 |
6-11 |
- |
+++ |
++ |
+++ |
+++ |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitising
- Conclusions:
- 2[(hydroxymethyl)amino]ethanol was observed for its skin sensitizing potential in human by patch test.In this limited series of patch testing, 2-[(hydroxymethyl) amino ] ethanol was the most allergenic to the patients after 72 hours observations.
- Executive summary:
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 observation
It can be concluded that2[(hydroxymethyl)amino]ethanol (34375-28-5)is a strong skin sensitizer in human .
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.