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Diss Factsheets
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EC number: 204-101-2 | CAS number: 115-70-8
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-amino-2-ethylpropanediol
- EC Number:
- 204-101-2
- EC Name:
- 2-amino-2-ethylpropanediol
- Cas Number:
- 115-70-8
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 2-amino-2-ethylpropane-1,3-diol
- Reference substance name:
- 2-Amino-2-ethyl-1,3-propanediol
- IUPAC Name:
- 2-Amino-2-ethyl-1,3-propanediol
- Details on test material:
- AEPD (P-1050)
Liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Lot No. NPP-41344
- Purity: 85.34%
- By-products
- Methanol: 1.48%
- Monomethyl amino butanol: 10.92%
- Water: 1.89%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals purchased at least 1 week prior to study and allowed to acclimatise. Healthy animlas free of disease were selected for the study. 24 hours prior to test, animals examined for skin injury. Those with no injury were used in test. Animals were fed Purina Certified Rabbit Chow, ad libitum, certified free of contaminants by supplier. Animals were given tap water ad libitum. Water was tested to ensure levels of contaminants are equivalent to or less than recommended levels as per the primary drinking water regulations.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 48 hours following treatment initiation
- Number of animals:
- 6
- Details on study design:
- The skin corrosion test was carried out in six albino rabbits weighing 2.4 +/- c0.2 kg. The backs were shaved free of hair. A 0.5 m l of liquid t e s t material was applied on the back of each rabbit and the treated skin site was covered with a gauze and a "Dermicel" tape. The animal trunk was then loosely wrapped with an impervious rubberized cloth and a flexible stainless steel protective screen held in place by tape. Following a 4-hour exposure period, the patches were removed and the treated skin sites were gently cleaned. The sites were visually evaluated for erythema, edema, and tissue destruction at 4, 24, and 48 hours after exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 4 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no skin effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- There was no erythema or edema in any of the rabbits at 4, 24, and 48 hours. The treated skin sites were normal and there was no tissue destruction. Nofurther recordings were made.
Any other information on results incl. tables
The liquid material applied easily on the skin. There was no erythema or edema in any of the rabbits at 4, 24, and 48 hours. The treated skin sites were normal and there was no tissue destruction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- AEPD was tested for its skin corrosion and irritation potential in rabbits. It resulted in no skin damage; thus AEPD was found to be non-corrosive. There were also no signs of irritation and therefore it is not considered to be irritating.
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