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EC number: 253-657-2 | CAS number: 37763-23-8
- 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
- Study period:
- end on 9-APR-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- EC Number:
- 253-657-2
- EC Name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- Cas Number:
- 37763-23-8
- Molecular formula:
- C9H11NO3
- IUPAC Name:
- methyl (2R)-2-amino-2-(4-hydroxyphenyl)acetate
- Details on test material:
- - Name of test material (as cited in study report): FGHM
- Molecular formula (if other than submission substance): C9H11NO3
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: stability in water not indicated
- Storage condition of test material: in refrigerator in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 1564 - 1740 g
- Housing: individually in labelled cages with perforated floor
- Diet: standard laboratory rabbit diet, approx. 100 g per day. In addition, hay was provided once a week.
- Water: free access to tap water diluted with decalcified water.
- Acclimation period: at least 5 days before start of the treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50%
- Air changes: approx. 15 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: data not available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- moistened
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: moistened with water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: shaved on 10 x 15 cm2
- % coverage: data not available
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with a tissue moistened with tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean vamue (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No skin irritation/corrosion was caused by FGHM after 4 hours of exposure.
All scores of erythema and edema were "0" at 1, 24, 48 and 72h. - Other effects:
- No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HPGM (FGHM) is not irritating to the skin in the rabbit.
- Executive summary:
In a primary dermal irritation study (OECD 404, GLP), 8 week old New Zealand White rabbits (3 males) were dermally exposed to 0.5 g of HPGM (FGHM) moistened with water for 4 hours under semi-occlusive conditions. Animals then were observed for 72 hours. Irritation was scored by the method of OECD guideline.
No skin irritation/corrosion was caused by FGHM after 4 hours of exposure.
All scores of erythema and edema were "0" at 1, 24, 48 and 72h.
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