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EC number: 247-415-5 | CAS number: 26021-57-8
- 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:
- From 05 May 1994 to 25 August 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- EC Number:
- 247-415-5
- EC Name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- Cas Number:
- 26021-57-8
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 3,4-dihydro-2H-1,4-benzoxazin-6-ol
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: not specified
- Weight at study initiation: mean body weight of 2.4 ± 0.1 kg
- Housing: the animals were housed individually in polystyrene cages (35 x 55 x 32 em or 48.2 x 58 x 36.5 em). Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): All the animals had free access to 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France).
- Water (e.g. ad libitum): drinking water filtered by a F.G. Millipore membrane (0.22 micron) and contained in bottles was provided ad libitum.
- Acclimation period: at least 5 days before the beginning of the study
There were no contaminants in the diet or water at levels likely to have influenced the outcome of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From 25 May 1994 To 28 May 1994
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
A dose of 500 mg of the test substance in its original form was applied to a 6 cm² hydrophilic gauze patch moistened with 0.5 ml of water for injections and this was then applied to the right flank.
NEGATIVE CONTROL
The left flank did not receive any test substance and served as control. - Duration of treatment / exposure:
- The test substance was applied to the right flank of rabbits for 4 hours.
- Observation period:
- The skin was examined approximately 1, 24, 48 and 72 hours after removal of the dressing. When there is no evidence of dermal irritation after 72 hours, the study is ended. Any change in the animals' behaviour was noted.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
The day before treatment, the flanks of each animal were clipped using electric clippers. Only animals showing no obvious signs of irritancy were used for the study.
The test substance and the gauze patch were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
Four hours after application, the dressings were removed and any residual test substance was removed with a dry gauze patch.
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the dressing
SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to the following scoring scale:
Erythema and eschar formation:
no erythema .......................................................................................................... 0
very slight erythema (barely perceptible) ............................................................. 1
well-defined erythema .......................................................................................... 2
moderate to severe erythema ............................................................................. 3
severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema formation
no oedema............................................................................................................. 0
very slight oedema (barely perceptible) .............................................................. 1
slight oedema (edges of area well-defined by definite raising) ......................... 2
moderate oedema (raised approximately 1 millimetre)...................................... 3
severe oedema (raised more than 1 millimetre and extending beyond area
of exposure) .......................................................................................................... 4
Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No cutaneous reactions were observed during the study.
- Other effects:
- None.
Any other information on results incl. tables
Table 1: Individual cutaneous examinations and mean score of the values recorded after 24, 48 and 72 hours for each animal
Rabbit number |
Dermal irritation |
Scores |
Mean irritation scores (24, 48, 72h) |
Interpretation |
|||
1h |
24h |
48h |
72h |
||||
01 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
|
Other |
none |
none |
none |
none |
|
|
|
|
|||||||
02 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
|
Other |
none |
none |
none |
none |
|
|
|
|
|||||||
03 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Non-irritant |
|
Other |
none |
none |
none |
none |
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this test, the test substance hydroxybenzomorpholine was considered as non-irritant when administered by cutaneous route in rabbits.
- Executive summary:
Approximately 24 hours prior to the application of hydroxybenzomorpholine, the flanks of 3 male rabbits were clipped free of fur. A 500 mg sample of neat hydroxybenzomorpholine moistened with 0.5 ml water was applied to a 6 cm² area of the right flank of each animal (the untreated left flank served as control). It was held in contact with the skin for 4 hours by means of a semiocclusive dressing.
Subsequently, the dressings were removed, any residual test substance was removed and the treated area was observed 1, 24, 48 and 72 hours afterwards.
Results
There were no skin reactions at any observation time-point.Conclusion
Under the conditions of this study, hydroxybenzomorpholine was non-irritating to rabbit skin when tested undiluted.
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