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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restriction; the study was conducted according to GLPs and OECD Guideline 405 .
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Due to a technician error, the animals did not receive local anesthetic prior to instillation of the test material. This deviation did not impact the quality or integrity of the study.
- GLP compliance:
- yes
- Remarks:
- Compliant with two exceptions; information about the test material characterization retained by the Study Sponsor, and Study Director did not fill in proposed Experimental Start and Termination dates before signing the protocol or prior to study start.
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 substance (as cited in the study report): 1, 4 Diethylhexyl terephthalate
-Batch number: TD5023342
-Purity: 98.21% (as provided on Certificate of Analysis). Impurities included water (0.0179%) and the ethylhexyl-methyl ester (1.60%).
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals:
-Source: Robinson Services, Inc. Clemmons, NC
-Sex: 1 male,and 2 females
-Age at study initiation: young adult
-Acclimation period: 23 days
-Housing: singly housed in suspended stainless-steel cages with mesh floor
-Diet: pelleted Purina Rabbit Chow #5326
-Water: filtered tap water ad libitum
-Method of animal identification: Uniquely numbered stainless steel ear tag
Environmental Conditions:
-Temperature: 20 - 24 °C
-Photoperiod: 12 hours light/12 hours dark
Study Dates:
-Study Initiation Date: 8 March 2006
-Experimental Start Date: 10 March 2006
-Experimental Completion Date: 13 March 2006
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each rabbit was not treated and served as a control.
- Amount / concentration applied:
- 0.1 mL undiluted
- Duration of treatment / exposure:
- The test substance (0.1 mL) was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for approximately 1 second. Eyes were not washed.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Prior to the test, both eyes of a group of animals were examined for pre-existing ocular irritation. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds later and subsequently evaluated for corneal damage using an ultraviolet light source. Three healthy animals without evidence of preexisting ocular irritation were selected for use in the study based on this screening procedure. The test substance (0.1 mL) was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for approximately 1 second. The other eye of each rabbit was not treated and served as a control. Ocular irritation, including effects on the cornea, iris, and conjunctiva were evaluated according to the method of Draize et al. (1944), using a high intensity white light (Mag Lite) 1, 24, 48 and 72 hours after instillation. In addition, flourescein dye was used as described above to evaluate corneal damage 24 hours after treatment. Individual scores were recorded for each animal. The average score for all rabbits was determined for each evaluation time. The time interval with the highest mean score for all rabbits was used to classify the test material according to the method of Kay and Calandra (1962). The animals were observed at least once daily for signs of gross toxicity and behavioral changes during the test period. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
References Cited:
Kay, JH and Calandra, JC, 1962. Interpretation of eye irritation tests. J. Soc. Cos. Chem. 13:281-289.
Draize et al., 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther., 82:377-390.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 10.7
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals
- Time point:
- other: 1 hour only
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: all other chemosis scores at 24 and 48 hours were 0
- Irritation parameter:
- other: redness score
- Basis:
- other: all animals
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Diffuse, deep crimson red, individuals not easily discernable
- Irritation parameter:
- other: redness score
- Basis:
- other: all animals
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Injected above normal
- Irritation parameter:
- other: redness score
- Basis:
- other: all animals
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: discharge score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Discharge with moistening of the lids and hair of a considerable area around the eye.
- Irritation parameter:
- other: discharge score
- Basis:
- other: animals #2 and #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Discharge with moistening of the lids and hair adjacent to the lids.
- Irritation parameter:
- other: discharge score
- Basis:
- other: all animals
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: The assigned score of 1 was based on the presence of any amount of discharge different from that normally seen in the untreated rabbit eye.
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no corneal opacity was observed at any time during the study
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no iritis was observed at any time during the study
- Irritation parameter:
- cornea opacity score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal opacity or iritis was observed in any treated eye at any time during the study. All three treated eyes exhibited conjunctivitis 1, 24 and 48 hours after instillation but were normal at 72 hours. Redness scores in the 3 rabbits were 2 (diffuse, deep crimson red, individual vessels not easily discernable), 1 (injected above normal), and 1 at 1, 24 and 48 hours, respectively. Chemosis scores of 1 (any swelling above normal) were recorded at 1 hour for all 3 animals (all other chemosis scores were 0). Discharge scores of 3 (discharge with moistening of the lids and hairs; considerable area around the eye), 2 (discharge with moistening of the lids and hairs just adjacent to the lids), and 2 were recorded in the three animals one hour after instillation. Discharge scores of 1 were observed in all 3 animals at 24 hours. The mean irritation scores at 1, 24 and 48 hours were 10.7 (12 + 10 + 10/3), 4.0 (4 + 4 + 4/3) and 2.0 (2 + 2 + 2/3) (respectively). All animals were free of ocular irritation by 72 hours. The maximum mean total score was 10.7, which corresponded to a classification of minimally irritating using the Kay and Calandra (1962) classification system. According to their guidance, since all scores were not 0 at 48 hours, the classification was increased one level (to mildly irritating from minimally irritating).
- Other effects:
- Other than minimal eye irritation, there were no other signs of toxicity or abnormal behavior.
Any other information on results incl. tables
Rabbit 1 | Rabbit 2 | Rabbit 3 | |||||||||||
Hours | Hours | Hours | |||||||||||
1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | ||
I. Cornea | |||||||||||||
A. Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
B. Area | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 | |
(AxB)x5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
II. Iris | |||||||||||||
A. Values | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Ax5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
III. Conjunctivae | |||||||||||||
A. Redness | 2 | 1 | 1 | 0 | 2 | 1 | 1 | 0 | 2 | 1 | 1 | 0 | |
B. Chemosis | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | |
C. Discharge | 3 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | |
(A+B+C)x2 | 12 | 4 | 2 | 0 | 10 | 4 | 2 | 0 | 10 | 4 | 2 | 0 | |
Total | 12 | 4 | 2 | 0 | 10 | 4 | 2 | 0 | 10 | 4 | 2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: minimally irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The maximum mean total score in a primary eye irritation study in rabbits was 10.7, which corresponded to a classification of minimally irritating according to the test scheme of Kay and Calandra (1962). According to their guidance, since all scores were not 0's at 48 hours, the classification was increased one level (to mildly irritating). There was no evidence of corneal opacity or iritis at any time during the study. Conjunctival redness was observed in all animals at 1, 24 and 48 hours but all animals were normal at the 72 hour observation period and the calculated mean score following grading at 24, 48 and 72 hours after installation of the test material was <2. Conjunctival chemosis (grade 1) was also observed in all animals at the 1 hour observation period but all animals were normal
at the 24 hour observation period. Based on these results, di (2-ethylhexyl) terephthalate is not classified as an ocular corrosive or irritant according to GHS. - Executive summary:
In an acute ocular irritation study, 0.1 mL of di (2-ethylhexyl) terephthalate was administered into the conjunctival sac of one eye of three New Zealand White Rabbits. The untreated eye of each rabbit served as a control. The eyes were examined at 1, 24, 48, and 72 hours post-instillation and graded according to the method of Draize. There was no evidence of corneal opacity or iritis at any time during the study. Signs of irritation were limited to conjunctivitis. Chemosis (grade 1) which was observed at the 1 hour observation period was absent at all later observation periods. Conjunctival redness (grade 2 at 1 hour and grade 1 at 24 and 48 hours) had cleared by 72 hours. The pattern of irritation which was observed led to a classification of the test substance as mildly irritating using the method of Kay and Calandra. However, the mean test scores did not meet the criteria for classification as corrosive or irritating to the eye under GHS. Based on the results of this study, di (2-ethylhexyl) terephthalate may cause slight transient ocular irritation and presents a low toxicity hazard.
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