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EC number: 251-780-6 | CAS number: 33996-33-7
- 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
Endpoint summary
Administrative data
Description of key information
Oxaceprol has to be classified as Eye Dam. 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-03-09 to 2001-11-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kyowa Hakko Kogyo Co., Ltd. / lot 000703
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: highly soluble
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: grounded to fine powder - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2001-05-18 or earlier To: 2001-05-28 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: distilled water - Duration of treatment / exposure:
- 1 h, 24 h, 48 h, 72 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Type of wrap if used: adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure:
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 3 min, 1 h, 24 h, 48 h, 72 h
SCORING SYSTEM:
- Method of calculation: according to Draize - Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not fully reversible within:
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- other: Erythema / eschar formation
- Basis:
- other: All 3 animals
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- other: All 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance Oxaceprol is not irritant or corrosive to the skin
- Executive summary:
The study according to OECD 404 was performed to assess the irritancy potential of Oxaceprol to the skin of the New Zealand White rabbit.
The test material procuded a primary irrittaion index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.
Oxaceprol did not meet the criteria for classification as irritnat or corrosive to the skin according to CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-02-13 to 1984-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- no
- Remarks:
- Study performed before introduction of OECD principles of GLP
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Degussa AG / 22.2393.12.01
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable according to information by Degussa AG
- Solubility and stability of the test substance in the solvent/vehicle: soluble
OTHER SPECIFICS: pH-value 0 1.7 (10.0 % solution) - Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Asta Werke AG
- Age at study initiation: 5 months
- Weight at study initiation: 2.10 - 2.35 kg
- Housing: stainless steel cages, type ASTA
- Diet (e.g. ad libitum):standardised test animal food for rabbits
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2°C
- Humidity (%): 55 % +/- 15 %
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From:1984-02-12 To: 1984-03-05 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- (21 d)
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 56.3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- Mean value "5" derived from 4 instead of 12 individual values as assessment was not possible for 2 animals due to severe cornea opacity.
- Time point:
- other: 1h, 24 h, 48 h, 72 h
- Score:
- ca. 5
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h, 24 h, 48 h, 72 h
- Score:
- 15.7
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- probability of severe irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The irritation index could not be derived due to methodological reasons as the iris could not be assessed with 2 animals due to severe cornea opacity.
The results from cornea and conjunctivae as well as the strong acidic pH value of 1.7 lead to the conclusion that oxaceprol has eye damaging properties under the conditions of the test. - Executive summary:
Oxaceprol was tested for eye damaging properties in a guideline study according to OECD 405. The irritation index could not be derived due to methodological reasons as the iris could not be assessed with 2 animals due to severe cornea opacity. The results from cornea and conjunctivae as well as the strong acidic pH value of 1.7 lead to the conclusion that oxaceprol has eye damaging properties under the conditions of the test.
Reference
Cornea:
After application almots the entire cornea showed opacity. Details of the iris were not observable value 39 or invisible (value 4). The opacity was not fully reversible with all animals after the 3 weeks observation period. Insertion of vascular vessels into the cornea was observed with 1 animal.
Iris:
The iris of all animals showed moderate circcum corneal hyper anemia until the end of the 3 weeks observation period (value 1). This diagnostic finding could not be assessesd before day 7 or day 8, resp., with 2 animals due to severe opacity of the cornea.
Conjunctivae:
The conjunctivae responded with diffuse respectively flesh-coloured redness (value 2 respectively 3). Additionally, suppurative focuses appeared with 2 animals over a short period of time. Swelling which resulted in semi or fully closed lids (value 3 repsectively 4) was observed with all animals. These reactions resolved almost complete until the end of the 3 weeks observation period.
Hypersecretion was observed with all animals. The hypersecretion moistened significant areas araound the eye and lasted until the end of the 3 weeks observation period. In addition, hair loss around the eye occured with 2 animals.
Systemic toxic effects:
Not observed.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
The pH-value of oxaceprol was measured not only in the key study for the endpoint "eye irritation" but in other contexts as well. pH-values were between 1.4 and 2.0
Justification for classification or non-classification
The results from cornea and conjunctivae as well as the strong acidic pH value of 1.7 lead to the conclusion that oxaceprol has eye damaging properties under the conditions of the test.
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