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EC number: 610-201-0 | CAS number: 446292-08-6
- 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
Skin corrosion in vitro (3D-skin model with EST-1000, GLP, OECD TG 431 guideline draft, EU Method B.40): not corrosive [Bayer AG, Report No. PH-34412, 2006-04-20]
Skin irritation in vivo (Rabbit-NZW, GLP, OECD TG 404, EU Method B.4): not irritating to the skin [Bayer AG, Report No. PH-34402, 2006-04-10]
Eye irritation in vivo (Rabbit-NZW, GLP, OECD TG 405, EU Method B.5): not irritating to the eye [Bayer AG, Report No. PH-34401, 2006-04-10]
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431 guideline draft
- Version / remarks:
- 1996/ 1998
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- purity 99.8%
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Corrosion of the skin is defined as an irreversible necrotic alteration of the tissue induced by a chemical. While the testing for corrosives usually involves the rabbit skin as a predictive in vivo test method, substances may be classified according to their corrosive potential by the determination of their cytotoxic effects on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after short term exposure of the epidermal equivalent to topically applied Oxaphthalimid.
- Vehicle:
- physiological saline
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT: 3 min; 37 ± 2°C: 60 min
- Temperature of post-treatment incubation (if applicable):
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 3 washing steps, volume not reported
- Observable damage in the tissue due to washing: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 2 h
- Spectrophotometer: (EL808, Bio-Tek; 96 well format, 200 µL)
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: not reported
- Procedure used to prepare the killed tissues (if applicable): not reported
- N. of replicates : not reported
- Method of calculation used: not reported
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: None - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1/ 60 min
- Value:
- 95.27
- Vehicle controls validity:
- valid
- Positive controls validity:
- not examined
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 / 3 min
- Value:
- 97.26
- Vehicle controls validity:
- valid
- Positive controls validity:
- not examined
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not corrosive to skin
- Executive summary:
The study on a reconstructed human epidermis EST-1000 was carried out for detection of topically applied skin corrosives with the test item Oxaphthalimid.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 minutes (room temperature) and 60 minutes (incubator), respectively. Using the MTT (methylthiazoletetrazolium) method the cell viability after 3 minutes or after 60 minutes of incubation was determined to be 97.26% and 95.27%, respectively. Thus, Oxaphthalimid was not characterised by a significant impact on cell viability and it therefore showed no corrosive properties.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar 2006
- 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:
- 2002
- 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:
- purity 99.8%
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany, 69592
- Age at study initiation: young adult animals
- Weight at study initiation: 2.6 kg — 2.8 kg
- Housing: The animals were housed individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “SsniffK-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- pulverized test item moistened with water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g - Duration of treatment / exposure:
- one animal: first patch removed after 3 minutes, second patch (because no serious skin reactions were observed after the first patch) removed after 1 hour and third patch removed after 4 hours
two more animals: exposed for 4 hours - Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 0.5 g of the pulverized test substance moistened with Aqua p.i. (to ensure good contact with the skin) was applied to the skin of the animal under a gauze patch. The patch was placed on the dorso-lateral areas of the trunk of each animal and was held in place with non-irritating tape for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposed skin area was carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48, 72 h
SCORING SYSTEM: The degree of erythema/eschar formation and oedema formation was recorded as specified by DRAIZE - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not irritating to skin
- Executive summary:
500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.
In this skin irritation study Oxaphthalimid was not irritating to the skin.
Referenceopen allclose all
The MTT method has determined the following values of viability:
after 3 min of incubation: 97.36%
after 60 min of incubation: 95.27%
Results of the study:
Irritant Effects (Scores) | ||||||||||
24 h | 48 h | 72 h | Mean scores | |||||||
animal | erythema | edema | erythema | edema | erythema | edema | erythema | edema | ||
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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:
- Mar 2006
- 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:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- purity 99.8%
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 88353 Kißlegg, Germany, 69592
- Age at study initiation: young adult animals
- Weight at study initiation: 2.5 kg — 2.8 kg
- Housing: The animals were housed individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettenmaier & Söhne, 73494 Rosenberg, Germany).
- Diet (e.g. ad libitum): The animals received the standard diet “SsniffK-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±25
- Photoperiod (hrs dark / hrs light): 12/12
- 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:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h
SCORING SYSTEM: According to DRAIZE
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: not reported - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is not an irritant to eyes
- Executive summary:
0.1 g of the test substance was administered into the conjunctival sac of in each case one rabbit eye of 3 females and after 24 h the treated eyes were rinsed with physiologic saline.
Evaluation of eye irritation was made according to Draize.
According to the classification criteria Oxaphthalimid is not irritating to eyes.
Reference
Results of the study
Irritant Effects (Score) | |||||
Animal | 24 h | 48 h | 72 h | Mean scores | |
1 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iritis | 0 | 0 | 0 | 0.0 | |
Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
2 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iritis | 0 | 0 | 0 | 0.0 | |
Redness conjunctivae | 1 | 0 | 0 | 0.3 | |
Chemosis conjunctivae | 0 | 0 | 0 | 0.0 | |
3 | Corneal Opacity | 0 | 0 | 0 | 0.0 |
Iritis | 0 | 0 | 0 | 0.0 | |
Redness conjunctivae | 0 | 0 | 0 | 0.0 | |
Chemosis conjunctivae | 0 | 0 | 0 | 0.0 |
All animals showed reddening of the conjunctivae 1 h after administration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
In the skin corrosion test in vitro with reconstructed human epidermis EST-1000 no corrosive property of the test item could be determined.
In the skin irritation test in all 3 animals no signs of skin irritation could be observed. There were no systemic intolerance reactions.
In the eye irritation test all animals showed reddening of the conjunctivae 1 h after instillation, only 2 of them had slight irritation signs at the conjunctivae after 24 h. All effects were fully reversible within 2 days. There were no systemic intolerance reactions.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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