Registration Dossier
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EC number: 204-709-8 | CAS number: 124-68-5
- 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
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- 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
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- Nanomaterial surface chemistry
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- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific standards, well-documented, and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Airborne Contact Dermatitis from 2-Amino-2-methyl-1-propanol in a Cosmetic Company
- Author:
- Cipolla et.al.
- Year:
- 1 977
- Bibliographic source:
- Arh. hig. rada. toksikol 48:205-209
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- not specified
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-amino-2-methylpropanol
- EC Number:
- 204-709-8
- EC Name:
- 2-amino-2-methylpropanol
- Cas Number:
- 124-68-5
- Molecular formula:
- C4H11NO
- IUPAC Name:
- 2-amino-2-methylpropan-1-ol
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- not specified
- Subjects:
- cosmetic company workers
- Clinical history:
- Two cases of airborne contact dermititis were noted in a cosmetic company during the hair dye production using AMP-100. Subjects suffered for months from periorbital oedema and facial erythema which worsened during work hours and improved with time away from work. Eight additional asymptomatic workers from the same company were studied concurrently.
- Route of administration:
- dermal
- Details on study design:
- Skin prick tests and patch tests with the test material and common inhalant allergens were performed on all subjects. AMP-100 was dissolved in both water and ethyl alcohol separately at 0.1%, 0.5%, 1%, 2%, 5%, 10%, 20%. Patch tests were applied on the back and read at 48 and 72 hours. Positive results were recorded for erythema, oedema, and blisters.
Results and discussion
- Results of examinations:
- The prick and patch tests were all negative except for one positive reaction to Dermatophagoides pteronyssinus in a worker on a different production line. All patch tests carried out with substances used in the production line proved negative except for AMP-100 at 10% and 20% dilutions in water and ethyl alcohol. All positive results manifested as erythema with oedema without blistering.
Positive results at 10% and 20% may be considered as irritative responses. There was lack of response to the lower doses (that would have been considered allergenic responses) noted in both the asymptomatic and symptomatic subjects.
Applicant's summary and conclusion
- Conclusions:
- The authors conclude that under these conditions, AMP-100 causes airborne irritative contact dermatitis, favored in this study by elevated production temperatures and high ambient humidity.
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