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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 9-APR-1996
- Reliability:
- 2 (reliable with restrictions)
- 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 405 (Acute Eye 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: not indicated
- Storage condition of test material: in refrigerator in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 7 or 10 weeks
- Weight at study initiation: 1378 to 2086 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 26 +/- 0.9 mg (approx. 0.1 mL)
- Concentration: undiluted - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean value (24, 48, 72h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Iridic irritation (grade 1) was noted in 2 animals at one hour after instillation only.
The irritation of the conjuntivae consisted of redness, chemosis and discharge (all at grade 1), which has resolved after 48h of treatment.
No corneal opacity was onserved and treatment of the eyes with 2% fluorescein, 24h after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion. - Other effects:
- No staining of the peri-ocular tissues by the test substance was noted.
Remnants of the test substance were present in the eye of all animals 1h after instillation.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0 / 0 / 0 |
0 / 1 / 1 |
1 / 1 / 1 |
0 / 0 / 1 |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0 / 0 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24h, 48h, 72h |
0 / 0 / 0 |
0 / 0 / 0 |
0.3 / 0.3 / 0.3 |
0 / 0 / 0 |
Reversibility |
- |
yes |
yes |
yes |
Average time for reversion |
- |
After 24h |
After 48h |
After 24h |
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 eye in the rabbit.
- Executive summary:
In a primary eye irritation study (OECD 405, GLP), 26 mg (ca. 0.1 mL) of undiluted HPGM (FGHM) was instilled into the conjunctival sac of one eye of New Zealand White rabbits (3 males). Animals then were observed for 72 hours. Irritation was scored by the method of OECD guideline.
Iridic irritation (grade 1) was noted in 2 animals at one hour after instillation only.
The irritation of the conjuntivae consisted of redness, chemosis and discharge (all at grade 1), which has resolved after 48h of treatment.
No corneal opacity was onserved and treatment of the eyes with 2% fluorescein, 24h after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion.
The mean scores at 24, 48 and 72h were:
- Cornea, Iris, Chemosis : 0
- Conjunctivae : 0.3
According to EC criteria for classification of dangerous substances (DSD directive and CLP regulation), HPGM (FGHM) is not classified as irritating to the eyes.
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.