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EC number: 241-774-1 | CAS number: 17796-82-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(cyclohexylthio)phthalimide
- EC Number:
- 241-774-1
- EC Name:
- N-(cyclohexylthio)phthalimide
- Cas Number:
- 17796-82-6
- Molecular formula:
- C14H15NO2S
- IUPAC Name:
- N-(cyclohexylthio)phthalimide
- Details on test material:
- Test batch No.: 041/07
Active substance: 99,42 % weight
Weight loss: 0,08 % weight
Toluene insolubles: 0,05 % weight
Ash: 0,008 % weight
Melting point: first liquid 92,3°C
complete liquid 92,5 °C
Sieve retention: 2,0 mm 0 %
0,5 mm 0 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Number and Sex: Four healthy young adult animals (males), weighing from 3,20 kg to 3,89 kg
Source: VÚŽV Nitra, Slovakia
Identification: The animals were housed individually in cages. The animals were marked by serial numbers 1 - 4. These numbers were placed on the cage and on the auricle.
Housing: Animals were housed in cages individually.
Diet: A standard certified laboratory diet ( supplier Top DOVO Dobrá Voda) was served.
Water: Ad libitum
Environment: Environmental controls for the animal room was set to maintain 18± 3°C, a relative humidity of 40 - 70 %a minimum of 10 air changes/hour, and a natural light regime.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Olivae oleum raffinatum
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- The test article was applied in a single dose to the clipped skin of experimental animals, each animal serving as its own control. A dose of 0,5 g Duslin was pulverised , moistened with olivae oleum and applied to the intact skin of rabbits for 4 h under semi-occlusive dressings.
The study was begun with an initial test using one animal. The test article was applied to a small ares (approximately 6 cm2 ) of skin and covered with a gauze patch. The patch was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period (4h). At the end of the exposure period, residual test preparation was removed using with olivae oleum. Because a corrosive effect was not observed in initial test, the irritant response was confirmed using up to three additional animals simultaneously. - Duration of treatment / exposure:
- Duration: 4h
- Observation period:
- Observation period: 1h, 24h, 48h and 72h after test
- Number of animals:
- four animals: albino rabbits (males)
- Details on study design:
- The study Duslin. Acute toxicity:Dermal Irritation/Corrosion (OECD 404) was performed according to SOP 001/215/03 in complince with the OECD
Guidelines for Testing of Chemicals - Method No 404 Acute Dermal Irritation/Corrosion, 2002 (OECD 404) and Principle of Good Laboratory Practice.
Evaluation of results:
For acute exposure, the Primary Irritation Index (PII) was determined as follows:
1. For each animal, the Irritation Scores for both erythema and oedema at each time specified were added together and divided by the total number of observations. Only 24h, 48h, 72h obsevations were used for calculations.
2. The irritation scores of each animal were added and divided by total number of animals. This value is the Primary Irritation Index.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 1,1
- Basis:
- animal #1
- Time point:
- other: after 24, 48 and 72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 1,1
- Basis:
- animal #2
- Time point:
- other: after 24, 48, 72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 1,1
- Basis:
- animal #3
- Time point:
- other: after 24, 48, 72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: weeping skin was appeared
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 1,1
- Basis:
- animal #4
- Time point:
- other: after 24, 48, 72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The degree of irritation was read and scored at specified intervals (1h, 24h, 48h and 72h following removal of the patches) and was described to
provide a complete evaluation of the effects. - Other effects:
- The Primary Irritation Index of Duslin for single exposure determined in this study was PII = 1,1. According to this value the test article belongs to
response category "Slight".
Any other information on results incl. tables
The moderate erythema classified as grad 3 was observed as the worst skin reaction on the Duslin. We did not observe erythema and oedema on the vehicle application site. During 7 days after removal of patches erythema was disappeared by all animals, but in animal No. 3 weeping skin was appeared. No oedema was occurred in the course of study.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
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