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EC number: 619-596-4 | CAS number: 915095-86-2
- 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:
- 16 Jul 2007 - 16 Oct 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- exception: The test article was characterized for composition and purity. However, it was not done under GMP/GLP. It was not characterized for stability.
Test material
- Reference substance name:
- (2-chloro-5-iodophenyl)(4-fluorophenyl)methanone
- EC Number:
- 619-596-4
- Cas Number:
- 915095-86-2
- Molecular formula:
- C13 H7 Cl F I O
- IUPAC Name:
- (2-chloro-5-iodophenyl)(4-fluorophenyl)methanone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: 14 weeks at start of dosing; records of dates of birth for animals used in this study are retained in the Calvert archives. Body weight range: 2.2-2.3 kilograms at the outset (Day 1) of the study. Animal Source: Harlan, Oxford, MI Experimental history: Purpose-bred and experimentally naive at the outset of the study. Identification: Ear tag and cage card. The rabbit is the standard species used in dermal irritation studies and is acceptable to regulatory agencies. The albino rabbit is recommended as the preferred species because of its size, skin permeability and published historical database for dermal irritation assays.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- Each animal received 500 mg of the test material on an intact skin site moistened with distilled water (0.3 ml).
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48, 72h
- Number of animals:
- 3 male
- Details on study design:
- The test article, IN 00078280, was applied to one site on the clipped dorsal trunk of three male New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrovisity were recorded for each 30-60 minutes after patch removal and at 24, 48 and 72 hours after unwrap. Grdaing of irritation was according to the method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A primary Irritation Index (PII) will be calculated from the erytherma and edema scores according to the following formula:
PII= Sum of erytherma and edema scores for the 1, 24, 48 and 72-hour evaluation
--------------------------------------------------------------------------------------------------
4 evaluation intervals x number of animals
The maximum possible score is 8.0. The PII of the test item will be used to classify the test article as follows:
Primary Irritation index (PII) Irritation Rating
----------------------------------------------------------
0 non-irritating
0.1-2.0 Slightly Irritating
2.1-5.0 Moderately Irritating
5.1-8.0 Severly Irritating
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. CLP
- Conclusions:
- The test article, BI 10773, was not found to be irritant to the skin of rabbits with a Primary Irritation Index score of 0.
- Executive summary:
A. Title Primary Dermal Irritation Study of IN 00078280 in Rabbits
B. Objective The purpose of this study was to determine the potential irritant and/or corrosive effects of IN 00078280 on the skin of rabbits.
C. Methods The test article, IN 00078280, was applied to one site on the clipped dorsal trunk of three male New Zealand White rabbits. The total exposure period was 4 hours. Observations for dermal irritation and corrosivity were recorded for each site 30-60 minutes after patch removal and at 24, 48 and 72 hours after unwrap. Grading of irritation was according to the method of Draize.
D. Results The Primary Irritation Index (PII) was calculated and determined to be 0.
E. Conclusion Under the conditions of this study, IN 00078280, was found to be a nonirritant to the skin of rabbits with a Primary Irritation Index score of 0.
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