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EC number: 416-740-6 | CAS number: -
- 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:
- 76 hours
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive patch used in testing
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- The animals were shaved on the day prior to test substance administration. One 1 square inch test site was selected on the right anterior flank and one 1 square inch test site on the right posterior flank of each animal. The sites were designated as anterior (1-hour occlusion) test site and posterior (4- hour, occlusion) test site. 0.5 ml of the test substance was applied to the posterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a non- irritating surgical tape. 0.5 ml of the test substance was applied to the anterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a nonirritating surgical tape. Elizabethan style collars were fitted to each animal after administration of the test substance.
Following a 1 hour exposure the anterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing.
Following a 4 hour exposure the posterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing. The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method. The collars were removed after the 24 hour ocular evaluation. Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter. The condition of each animal (live, dead, moribund) was checked at least once daily in the morning. - GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 416-740-6
- EC Name:
- -
- Molecular formula:
- Can vary from C30H53O4 (di-C11 rxn product) to C36H65O4 (di-C14 rxn product)
- IUPAC Name:
- Ester reaction products of 1,4-Benzenedicarboxylic acid with C11-14 iso-alcohols, C13-rich
- Details on test material:
- The test substance is a colorless homogeneous liquid. This material as stated in the Product Physical And
Chemical Data sheet is a terephthalate ester (di-tridecyl terephthalate).
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male and three female young adult New Zealand White rabbits obtained from Hazieton Research Products, Inc. (Denver, PA.) were used in this study. The animals were identified by individual ear tags and cage cards. The temperature of the study room was maintained at 70-72° F with a relative humidity of 44-61%.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 1 hour or 4 hours
- Observation period:
- 1, 4.5, 28, 52, and 76 hours post treatment
- Number of animals:
- 3 male and 3 female
- Details on study design:
- The animals were shaved on the day prior to test substance administration. One 1 square inch test site was selected on the right anterior flank and one 1 square inch test site on the right posterior flank of each animal. The sites were designated as anterior (1-hour occlusion) test site and posterior (4- hour, occlusion) test site. 0.5 ml of the test substance was applied to the posterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a non- irritating surgical tape. 0.5 ml of the test substance was applied to the anterior test site under Webril patches. The patches were secured with an occlusive rubber dam followed by a nonirritating surgical tape. Elizabethan style collars were fitted to each animal after administration of the test substance.
Following a 1 hour exposure the anterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing.
Following a 4 hour exposure the posterior site was unwrapped and evaluated for dermal corrosion. The residual test substance was wiped from the test site with cotton dampened with saline and the site reevaluated for corrosion at 48 hours post-dosing. The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method. The collars were removed after the 24 hour ocular evaluation. Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter. The condition of each animal (live, dead, moribund) was checked at least once daily in the morning.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 52 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4.5 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4.5 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4.5 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 4.5 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 4.5
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 4.5 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was also evaluated for dermal irritation at 4.5, 28, 52, and 76 hours post-dosing according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 24 hours after a 4-hour occlusion (noted as 28 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 48 hours after a 4-hour occlusion (noted as 52 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 28 hours
- Remarks on result:
- other: The test site was evaluated for dermal irritation 72 hours after a 4-hour occlusion (noted as 76 hours post-dosing by authors) according to the Draize method.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The erythema and edema scores for 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich are less than 2.3. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich as an irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Three male and three female New Zealand white rabbits were treated with 0.5 mL of 1,4 -Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich for 1 or 4 hours to assess skin irritation and corrosion. Clinical observations were made at 4.5, 28, 52, and 76 hours post exposure. Slight erythema (mean Draize score of 1) and edema (mean Draize score of 0.2) were observed at 4.5 hours, but at completely reversed by 52 hours. This finding does not warrant the classification of 1,4-Benzenedicarboxylic Acid, Di-C11-14-Isoalkyl Ester, C13-Rich under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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