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EC number: 246-119-3 | CAS number: 24280-93-1
- 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:
- June 08 to 11, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study, conducted according to internationally accepted technical guidelines and in compliance with GLP in recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- of 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- of 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Mycophenolic acid
- EC Number:
- 246-119-3
- EC Name:
- Mycophenolic acid
- Cas Number:
- 24280-93-1
- Molecular formula:
- C17H20O6
- IUPAC Name:
- 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
- Reference substance name:
- 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic acid
- EC Number:
- 207-595-8
- EC Name:
- 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methylhex-4-enoic acid
- Cas Number:
- 483-60-3
- Molecular formula:
- C17H20O6
- IUPAC Name:
- 6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydro-2-benzofuran-5-yl)-4-methylhex-4-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): MYCOPHENOLIC ACID
- Appearance: White powder
- Expiration date of the lot/batch: 01 November 2000
- Storage conditions: In refrigerator in the dark
- Stability under storage conditions: Stable
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Age at study initiation (day of dosing): 9 - 12 weeks.
- Number and Sex: 3 males
- Animal supplier: Charles River, Nederland
- Weight at study initiation: Minimum 1453 g, maximum 1719 g (3 males each 8 weeks old).
- Housing: Individual housing in cages with perforated floor and automatic drinking system.
- Diet (approx. 100 g/day): Commercially available pelleted rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits Altromin, Germany).
- Hay (once/week): Supplier: BMI, Helmond, The Netherlands)
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before treatment start under laboratory conditions.
ENVIRONMENTAL CONDITIONS
Animal housing and environmental conditions were appropriate for skin irritation / corrosion testing in the rabbit: Controlled environment with approximately 15 air changes per hour, 12 hours artificial fluorescent light and 12 hours darkness per day and optimal conditions considered to be 21ºC and 50% relative humidity. Fluctuations from these optimal conditions were not considered to have affected the study integrity.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: once or, if appropriate more often, clipped with electric clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test substance moistened with water per approx. 6 cm2 (2 x 3 cm) skin per animal.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours post patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE PREPARATION:
Approximately 24 hours before exposure an area of approximately 10x15 cm on the back of the animal was clipped. If considered necessary, area foreseen for treatment was re-clipped at least 3 hours before treatment start to facilitate evaluation of the skin reactions. During health inspection of the animals prior to commencement of treatment, special attention was paid to the skin to be treated, which was intact and free from abnormalities.
- Area of treated skin: Approx. 6 cm2 (= 2x3 cm).
- Type of wrap used: Metalline patch (2x3 cm) mounted on micropore tape which was wrapped around the abdomen
and secured with Coban elastic bandage.
TEST MATERIAL AND DOSE PREPARATION
- Administration Volume/animal (2x3 cm):
0.5 g Mycophenolic Acid moistened with water (= vehicle) to ensure close contact with the animal's skin.
- Vehicle: Water (Milli-U).
- Justification for choice of vehicle:
The test substance is stable for at least 96 hours in water and no adverse side effects of this vehicle on the animals
are to be expected
TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
Semi-occlusive treatment lasted 4 hours. Then the dressings were removed and the skin cleaned of residual test substance using water.
SCORING SYSTEM:
The treated skin patches were evaluated at 1 hour post end of exposure (not included in the mean dermal irritation score nor used for irritation/corrosion classification) and at 24, 48 and 72 h post end of exposure (included in the mean dermal irritation score and used for irritation/corrosion classification).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema or eschar formation was not evident
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: edma formation was not evident
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In each animal, erythema, eschar or edema formation was not evident at any observation time point of the study.
- Other effects:
- Mortality, symptoms of systemic toxicity or staining of the treated skin were not evident.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In view of the absence of any irritating effects during the present study and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] the test substance is considered "not irritant" and not having any labelling requirement regarding skin irritation.
- Executive summary:
Mycophenolic Acid was tested for skin irritation/corrosion according to OECD TG 404 of 1992 and the corresponding EC Technical Guideline B.4 of 1992 in compliance with GLP. Reliability grade 1 was assigned to the study.
Each of three New Zealand White rabbits was treated for 4 hours by semi-occlusive administration of a single dose of 0.5 g Mycophenolic Acid moistened with water. The test substance was administered to clipped intact skin (approximately 6 cm2/animal). Skin reactions were assessed 1, 24, 48 and 72 hours post patch removal.
In each animal, erythema, eschar or edema formation was not evident at any observation time point of the study. In addition, mortality, symptoms of systemic toxicity or staining of the treated skin were not evident.
In view of the absence of any irritating effects during the present study and according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] the test substance is considered "not irritant" and not having any labelling requirement regarding skin irritation.
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