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Diss Factsheets
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EC number: 253-649-9 | CAS number: 37743-18-3
- 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:
- 2003-11-24 to 2003-12-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to OECD Guideline 404 study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
Test material
- Reference substance name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- EC Number:
- 253-649-9
- EC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Cas Number:
- 37743-18-3
- Molecular formula:
- C18H20NO.Br
- IUPAC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test material applied - Duration of treatment / exposure:
- A single 4-hour semi-occluded application to the intact skin of 3 male rabbits; 3 minute and 1-hour semi-occluded application to the intact skin of 1 male rabbit.
- Observation period:
- at 1, 24, 48, and 72 h intervals after administration
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Draize Scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal: 147
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Remarks:
- mean
- Basis:
- animal: 148
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not applicable
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal: 147
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not applicable
- Irritation parameter:
- edema score
- Remarks:
- mean
- Basis:
- animal: 148
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- not applicable
- Irritant / corrosive response data:
- The test substance caused mild erythema at 24 and 48 h at 2 skin sites. The erythema had reversed by the 72 h observation. No edema was evident at any time at any skin site. No response was noted in the rabbit treated for 3 minutes and 1 hour.
Any other information on results incl. tables
Expert report (issued 2015 -04 -29 by data-owner):
The expert report provides an expert judgement of T000836 of study SPL 1827/115.
The expert conclusion stated: Three animals were observed for skin irritation after a dermal application of the test substance. For each of the three test animals the average scores for three consecutive days (usually 24, 48 and 72 hours) were calculated separately for oedema and erythema. Due to the fact that the cut-of value defined in the criteria of the GHS regulation (i.e. 1.5) was not reached for at least two animals out of three, the test item is not considered as a skin irritant according to the new guidelines. For this reason it was decided not to classify the compound as a skin irritant.
Reason for expert report: criteria for classification changed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be mildly irritating to rabbit skin. However, based on the criteria of the CLP Regulation, the test item should not be classified for skin irritation as reversible effects are observed and the scores for erythema and edema of the three animals were below the cut-off value of 2.3.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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