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EC number: 213-497-6 | CAS number: 959-26-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- The basis for this read-across approach is that the target substance is expected to undergo transformation into terephthalic acid (202-830-0; 100-21-0) and ethane-1,2-diol (203-473-3; 107-21-1). The toxicity of the metabolites will accurately predict the toxicity of the bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6). Refer to the JUSTIFICATION FOR READ-ACROSS OF TOXICOLOGICAL INFORMATION in Section 13 of this dossier for further details.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A radiotracer study was conducted in rats to determine the rate of absorption, distribution and excretion of the test substance following dermal application.
- GLP compliance:
- no
- Remarks:
- pre-dates GLP
- Type of study:
- other: A radiotracer study was conducted in rats to determine the rate of absorption, distribution and excretion of the test substance following dermal application.
- Justification for non-LLNA method:
- Study conducted in 1975
- Specific details on test material used for the study:
- radiolabelled [14C]-terephthalic acid
- Species:
- other: rat
- Strain:
- other: Charles River
- Sex:
- male
- Details on test animals and environmental conditions:
- The animals were adult male Charles River rats weighing 200-225 g. Animals were housed in metabolism cages during the study, and allowed free access to food and water.
- Details on study design:
- labeled TA were prepared in 1% solutions of Triton-X-100.
The doses of TA were applied in 0.2 ml of vehicle to the unabraded, depilated backs of rats. The rats received the same dose on alternate days for 10 consecutive days (five doses).
After dosing, the treated area of the back was covered with a gauze patch. - Key result
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not determinable because of methodological limitations
- Group:
- negative control
- Remarks on result:
- not determinable because of methodological limitations
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The OECD SIDS document references this study and reports that terephthalic acid is not sensitizing.
At the time of final patch removal, there was no evidence of skin irritation at the application site of animals treated with [14C]-TA.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- according to Magnusson and Kligman
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1996 when the GPMT was an international accepted and recommended method to assess skin sensitizing properties.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Housing: individually, in stainless-steel wire-mesh cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2°C
- Humidity (%): 55 ± 5% - Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- 0.2 % (w/w) and 100 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- 100 %
- No. of animals per dose:
- 4
- Details on study design:
- This test was performed according to the method of Magnusson and Kligman. A total of 19 guinea pigs were used. For sensitization, the solution for injection was prepared by mixing equal volumes of Freund's complete adjuvant and distilled water using two 5-mL glass syringes and stainless-steel syringe connector. The experimental dentin primers were diluted with olive oil and acetone (7: 3 v/v). Based on the findings of one of our previous papers, the 2-HEMA (2-hydroxyethyl methacrylate), HD (1,6-hexanediol) and EG (ethylene glycol) solutions for this test were diluted with olive oil and acetone at concentrations of 0.2% by weight. In the first stage of induction, 50 µL of each experimental dentin primer solution was intradermally injected into the back skin near the neck. One week later, as the second stage of induction, a filter paper patch soaked in 0.2 mL (100%) of experimental dentin primer was placed onto the shaved back of the guinea pigs. Finally, the experimental dentin primers (100 µL and 100% each) were applied to the skin at two sites using an Eppendorf filter paper under a sealed dressing for induction for 24 hours.
- Positive control substance(s):
- yes
- Remarks:
- 2-hydroxyethyl methacrylate
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.2% by weight
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethane-1,2-diol (203-473-3; 107-21-1) is not a skin sensitizer
Data source
Materials and methods
Test material
- Reference substance name:
- Bis(hydroxyethyl) terephthalate
- EC Number:
- 213-497-6
- EC Name:
- Bis(hydroxyethyl) terephthalate
- Cas Number:
- 959-26-2
- Molecular formula:
- C12H14O6
- IUPAC Name:
- bis(hydroxyethyl) terephthalate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Bis(2-hydroxyethyl) terephthalate value is read-across from supporting terephthalic acid (202-830-0; 100-21-0) and ethane-1,2-diol (203-473-3; 107-21-1) data.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Not applicable - read-across
- Group:
- test chemical
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: not applicable
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- other: not applicable
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing for each source substance, terephthalic acid (202-830-0; 100-21-0) and ethane-1,2-diol (203-473-3; 107-21-1), reported no skin sensitisation; therefore, it was predicted that BHET will not be sensitising to the skin.
- Executive summary:
The in vivo skin sensitisation of terephthalic acid was assessed in guinea pigs. Terephthalic acid was reported to be non-sensitising to guinea pigs. Following the guinea pig maximization test methodology of Magnusson and Kligman, ethylene glycol was assessed for its skin sensitisation potential. The study reported that none of the four animals tested had a skin sensitisation reaction. For a substance to produce skin sensitisation, skin penetration to some extent would occur which would expose the target substance to esterases which would metabolize the target substance into the two source substances. As in vivo testing for each source substance reported no skin sensitisation, it was predicted that BHET will not be sensitising to the skin.
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