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Diss Factsheets
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EC number: 204-100-7 | CAS number: 115-69-5
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final amended report on safety assessment on aminomethyl propanol and aminomethyl propanediol
- Author:
- Burnett et al.
- Year:
- 2 009
- Bibliographic source:
- Int. J. Toxicol. 28(65): 141S-161S
Materials and methods
- Principles of method if other than guideline:
- An inhalation toxicity study of a hair spray containing 0.135% of the test substance was performed using female Charles River rats. The rats were exposed for 4 hours a day, 5 days a week for 13 consecutive weeks to an aerosol containing 10 or 100 mg/m3 of 2 different hair spray formulations. The the body weight was recorded and hematological and clincial chemistry parameters were measured. The rats were necropsied, and tissues were subject to histopathological examination. The study was performed in 1975.
- GLP compliance:
- no
- Remarks:
- performed prior to GLP
- Limit test:
- no
Test material
- Reference substance name:
- 2-amino-2-methylpropane-1,3-diol
- EC Number:
- 204-100-7
- EC Name:
- 2-amino-2-methylpropane-1,3-diol
- Cas Number:
- 115-69-5
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-amino-2-methylpropane-1,3-diol
- Details on test material:
- - Name of test material (as cited in study report): Aminomethyl propanediol, AMPD
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Chr/CD Charles River
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet: The animals had acces to feed ad libitum
- Water: The animals had acces to water ad libitum
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature, humidity, pressure in air chamber: The temperature, pressure, and humidity levels were closely monitored.
TEST ATMOSPHERE
- Samples taken from breathing zone: Yes. Aerosol concentrations in the inhalation chambers were monitored hourly and adjusted as necessary. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 hours per day
- Frequency of treatment:
- 5 days per week, for 13 weeks (32 exposure days)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
10, 100 mg/m3
Basis:
other: nominal concentration; 0.135% test substance in formulation with 3% ethylene maleic anhydride copolymer, 50%
- Remarks:
- Doses / Concentrations:
100 mg/m3
Basis:
other: nominal concentration; 0.135% test substance in formulation without 3% ethylene maleic anhydride copolymer, 50%
- No. of animals per sex per dose:
- 16
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: 2 hair spray formulations (particle size not available) containing 0.135% of the test substance were tested. Hair spray formulation 1 contained 3% ethylene maleic anhydride copolymer, 50%; while formulation 2 did not contain the ethylene maleic anhydride copolymer. In addition, a control group was used.
After 32 exposure days, 5 animals of each species from each group were killed. The remaining test animals were killed starting 3 days after the last day of exposure.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes.
HISTOPATHOLOGY: Yes.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
The mortality in the control, 10% formulation 1, 100% formulation 1 and 100% formulation 2 groups was 0/16, 1/16, 0/16 and 1/16. The mortality was probably not an adverse effect of the test substance, as there was no dose-response relationship. No clinical signs were reported.
BODY WEIGHT AND WEIGHT GAIN
There were no statistically significant changes in body weight in any of the groups.
HAEMATOLOGY
There were scattered incidences of statistically significant differences in various hematology parameters; according to the authors there were no dose- or exposure-dependent trends were noted. This conclusion could not be verified as the data was not included in the review.
CLINICAL CHEMISTRY
There were scattered incidences of statistically significant differences in various clinical chemistry parameters; according to the authors there were no dose- or exposure-dependent trends were noted. This conclusion could not be verified as the data was not included in the review.
ORGAN WEIGHT
There were no differences in organ weight between the control and treatment groups.
GROSS PATHOLOGY
There were no notable gross pathology findings.
HISTOPATHOLOGY: NON-NEOPLASTIC
There were no notable histopathology findings.
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/m³ air (nominal)
- Based on:
- other: formulation with 0.135% test substance
- Sex:
- male/female
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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