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EC number: 229-176-9 | CAS number: 6422-86-2
- 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:
- 8 days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Reliable without restriction; study was conducted according to acceptable scientific methodology and according to Good Clinical Practices (GCPs). The investigation was reviewed by an Institutional Review Board in accordance with Title 21 of the U.S. Code of Federal Regulations (CFR).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Principles of method if other than guideline:
- The test substance was evaluated in 18 test subjects. Subjects were patched dermally on the back under semi-occlusive patches with 0.2 mL of five dilutions of the test substance in acetone. Subjects were patched three times over a period of five days (Days 1, 3, and 5). The subjects removed the patches after 24 hours, and scoring of patch sites for irritation was made prior to applications on Days 3 and 5 and on Day 8. Dermal reactions, if any, were assessed to determine the primary irritation potential of the test substance. The clinical investigation was reviewed by an Institutional Review Board in accordance with CFR, Title 21, Parts 50 and 56.
- GLP compliance:
- yes
- Remarks:
- As this was a human clinical study, it was conducted in compliance with Good Clinical Practice Regulations.
Test material
- Reference substance name:
- Bis(2-ethylhexyl) terephthalate
- EC Number:
- 229-176-9
- EC Name:
- Bis(2-ethylhexyl) terephthalate
- Cas Number:
- 6422-86-2
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) benzene-1,4-dicarboxylate
- Reference substance name:
- Reference substance 001
- Cas Number:
- 6422-86-2
- Details on test material:
- -Test material (as cited in study report): Eastman DOTP Plasticizer
-Source: Eastman Chemical Company
-Lot No: M04595, EAN 907040
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- -A total of 38 persons were screened for the study; eighteen subjects (9 males and 9 females) were enrolled and completed all phases of the study.
Study Dates:
-Study Initiation: March 12, 2001
-Study Completion: March 19, 2001
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- other: acetone
- Controls:
- other: Skin adjacent to the application site was used as a control.
- Amount / concentration applied:
- 0.2 mL of 0.01, 0.05, 0.1, 0.2, and 0.5% of the test substance in acetone
- Duration of treatment / exposure:
- Each subject received three 24 hour dermal applications of each of the five dilution preparations used in the study.
- Observation period:
- All sites were scored for irritation approximately 48 hours after patch application.
- Number of animals:
- 9 males and 9 females
- Details on study design:
- A series of skin sites on the back were used for the application of 0.2 mL of a preparation containing 0.01, 0.05, 0.1, 0.2, and 0.5% of the test substance in acetone. The application sites were semi-occluded using a non-woven cotton pad (Webril) held in place on all sides by a strip of hypoallergenic tape (Micropore) for approximately 24 hours. Applications were made on Days 1, 3, and 5; subjects removed the patches 24 ± 1 hr after applications, and scoring took place on Days 3, 5, and 8. The assignment of the five test substance preparations to individual skin sites were varied in order to eliminate any position or order bias.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Irritation score
- Basis:
- other: Human
- Remarks:
- Human
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Not performed
- Basis:
- other:
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Not performed
- Basis:
- other:
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At 48 or 72 hours after patch application, individual overall irritation scores ranged from 0 to 1 (mild erythema (pink)). Reversibility was not addressed. Average scores for the evaluations made on Days 3, 5, and 8 and the overall average score for the different concentrations of the test substance were as follows:
0.01%: 0.00, 0.03, 0.00, and 0.06
0.05%: 0.03, 0.03, 0.06, and 0.11
0.1%: 0.00, 0.03, 0.03, and 0.06
0.2%: 0.00, 0.00, 0.00, and 0.00
0.5%: 0.00, 0.03, 0.03, and 0.06
Any other information on results incl. tables
Since the irritation that was noted was minimal and did not occur in a concentration-dependent manner, it was not considered to be related to test substance exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on minimal irritation which did not occur in a concentration-dependent manner following three 24-hour applications to intact human skin under semi-occlusive contact, di (2-ethylhexyl) terephthalate is not classified as a primary skin irritant. Therefore, the concentration selected for use in a subsequent HRIPT study was the top concentration, 0.5%.
Under the conditions of the study, di (2-ethylhexyl) terephthalate is not classified under GHS. - Executive summary:
In a primary dermal irritation study, 18 panelists (9 male and 9 female) were exposed to di (2-ethylhexyl) terephthalate at concentrations of 0.01, 0.05, 0.1, 0.2, and 0.5% under semi-occlusion for three 24 hour periods over a period of six days. After 24 hours of exposure, the patches were removed, and 48-72 hours after patch application, the sites were graded for irritation. The maximum irritation score noted was 1 on a scale of 1-3. Irritation was seen irregularly and only at a small proportion of the application sites, was not observed in a concentration-dependent manner, and was therefore not considered to be related to test substance exposure.
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