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Diss Factsheets
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EC number: 202-802-8 | CAS number: 99-93-4
- 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, other
- Remarks:
- in vivo study available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
Test material
- Reference substance name:
- 4'-hydroxyacetophenone
- EC Number:
- 202-802-8
- EC Name:
- 4'-hydroxyacetophenone
- Cas Number:
- 99-93-4
- Molecular formula:
- C8H8O2
- IUPAC Name:
- 1-(4-hydroxyphenyl)ethan-1-one
- Details on test material:
- Name of the test substance used in the study report: C-01650 (4-HAP)
Purity: 99.97%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Weight: 2.0 - 4.0 kg at time of dosing
Each animal was assigned a unique and individual number. This number was permanently indicated on each animal with an ear tag.
Animals were housed separately from any other species. They were individually housed in stainless steel, wire mesh bottom cages.
Room temperature: 63 - 73°F; relative humidity: 30 - 70%; day/night rhythm: 12 h dark/12 h light.
Fresh certified rabbit feed and fresh potable water were provided ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- The eyes were examined 1, 24, 48 and 72 h following test article administration and also on days 4, 7, 14 and 21 of the study where appropriate. Scoring was done according to the method of Draize.
Responses of cornea, iris and conjunctivae were examined using a hand held ophthalmoscope.
In addition, the eyes were examined at 24, 48 and 72 h as well as on day 4 and day 7 where appropriate with fluorescein
stain.
One animal was dosed initially to determine the potential for the test article to produce ocular irritation prior to treating multiple animals. For this animal the treated eye remained unrinsed. Dependent upon the response noted in this animal, additional testing was performed, i.e. in this case, additional testing was done in 3 rabbits, where anesthetic was used prior to dosing as well as for the control eye. The eyes were rinsed 30 seconds after test material administration for approx. 30 seconds using a volume of approx. 120 ml 0.9% saline at room temperature.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- other: rinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: unrinsed eye
Any other information on results incl. tables
Results for the initially treated animal that remained unrinsed:
-At the 1 h reading corneal opacity 2 was noted with the area involved ranging from 50 to 75%: Conjunctival redness 2, chemosis 3 and discharge 2 were also noted.
-At the 24 h reading corneal opacity 2 was noted with the area involved ranging from 75 to 100%.
Iridial irritation 1 was noted.
Conjunctival redness 2, chemosis 3 and discharge 3 were also noted.
Fluorescein staining of the corneal epithelium was evident with the area involved ranging from 75-100%.
Hair loss below the lower eyelid was also seen which remained the same until day 14 when new hair started growing in the
area.
-At the 72 h reading corneal opacity 2 was noted with the area involved ranging from 50-75%.
Iridial irritation 1, conjunctival redness 2, chemosis 2 and discharge 3 were still noted.
Fluorescein staining was evident with the corneal area involved ranging from 25-50%.
On day 21 of the study, the unrinsed animal was free of ocular irritation.
The maximum Draize score was recorded 48 h after treatment and was 63/110.
Results for the animals of the rinsed group:
The rinsed eyes showed somewhat milder conjunctival effects which were completely resolved by observation day 7. Slight corneal opacity was reported in 2/3 animals but only at the 24-h reading.
On day 7 of the study, all of the rinsed animals were free of ocular irritation.
According to the authors, the classification of the test material is considered to be a severe irritant based upon the maximum total score of 63 calculated for the initially treated rabbit, that remained unrinsed.
The irritation appeared to be essentially fully reversible within 21 days of treatment. The rinsing procedure for the additional 3 treated animals appeared to have reduced the severity and duration of irritation. Based upon the mean total score of 22 calculated for the three rabbits in the rinsed group, the classification considered to be as a moderate irritant.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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