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EC number: 429-990-6 | CAS number: -
- 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
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- Flash point
- Auto flammability
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
- Biodegradation
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- 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 1998-02-18 to 1998-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- cited as: Directive 92/69/EEC method B4, from 29 Dec 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted: 17 Jul 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 429-990-6
- EC Name:
- -
- Molecular formula:
- Not applicable as multi-const. substance. Please refer to IUCLID section 1.2 for details on constituents.
- IUPAC Name:
- 2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol; 2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate; 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol; bis{2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl} carbonate; methyl 2-[(2R)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate; methyl 2-[(2S)-2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethyl carbonate
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd. Margate
- Age at study initiation: 10 to 14 weeks old
- Weight at study initiation: 2.35 to 2.58 kg
- Housing: floor-pens, minimum floor area of 0.6 sq m
- Diet: ad libitum, SQC TRB Rabbit Diet 9603 (pelleted) from Harlan Teklad. Bicester
- Water: tab water, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 22 °C.
- Humidity (%): 40 - 80 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod: 12 hours light, from 6.00 a.m to 6.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 500 mg - Duration of treatment / exposure:
- 4 h
- Observation period:
- 15 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 10x8 cm
- % coverage: not specified
REMOVAL OF TEST SUBSTANCE
- Washing: not performed
- Time after start of exposure: 4 hours
SCORING SYSTEM: Macroscopic Dermal Grading System based on Draize (erythema /edema score).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max. duration: 8 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean)
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Max. duration: 8 d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 14 days. Based on the Regulation (EC) No 1272/2008 (CLP) , the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single semi-occluded application of Incozol LV to intact rabbit skin for four hours caused marked inflammation and other dermal changes including petechial haemorrhage. However, all overt signs of irritation resolved within fourteen days of treatment. Thus, based on the Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.
- Executive summary:
A study was conducted according to OECD TG 404 and Directive 92/69/EEC method B.4 to assess the irritation or corrosion caused to the intact dorsal skin of rabbit following a single (4 hour) semi-occluded topical application of Incozol LV. Therefore, 3 New Zealand White rabbits were administrated to the test item Incozol LV. A single semi-occluded application of Incozol LV to intact rabbit skin for four hours caused marked inflammation and other dermal changes including petechial haemorrhage. However, all overt signs of irritation resolved within fourteen days of treatment. Thus, based on the Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a non-irritant to the skin of the rabbit based on both, the erythema and edema score.
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