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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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 irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Guideline:
- other: Not Reported
- GLP compliance:
- yes
- Species:
- rabbit
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- overall irritation score
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Terephthalic acid is not irritating to skin.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- - Reliability scoring based on 2002 guideline.
- Deviations:
- yes
- Remarks:
- - Insufficient details on test substance and study design; no individual data.
- GLP compliance:
- no
- Specific details on test material used for the study:
- test concentration: 100%
Reported as: Ethylene glycol - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: undiluted and diluted in water
- Controls:
- no
- Duration of treatment / exposure:
- Not reported.
- Observation period:
- Not reported.
- Number of animals:
- Not reported.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: Primary cutaneous irritation index
- Basis:
- mean
- Remarks:
- Undiluted test substance
- Time point:
- other: Not reported
- Score:
- 0.08
- Max. score:
- 2
- Reversibility:
- no data
- Other effects:
- Results for rabbits tested with 10% diluted in water not reported. No further details reported.
- Interpretation of results:
- other: unable to classify, documentation insufficient for assessment.
- Conclusions:
- Ethylene glycol is not irritating to skin.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 6-week cumulative irritation test in rabbits.
- GLP compliance:
- no
- Specific details on test material used for the study:
- test concentration: 100%
Reported as: Ethylene glycol - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- no
- Duration of treatment / exposure:
- 6 weeks
- Observation period:
- Daily readings for 6 weeks of treatment. Study of recovery from cutaneous injuries by stopping application for 7 days and examining the skin after this rest.
- Number of animals:
- 3 rabbits.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable because of methodological limitations
- Irritation parameter:
- other: MMII
- Basis:
- mean
- Remarks:
- -Undiluted test substance
- Time point:
- other: Addition of the erythema and oedema scores obtained each week (from five daily readings)
- Score:
- 0.47
- Reversibility:
- no data
- Remarks on result:
- other: Well tolerated; Maximum score not reported
- Irritation parameter:
- other: MMII
- Basis:
- mean
- Remarks:
- -10% test substance
- Time point:
- other: Addition of the erythema and oedema scores obtained each week (from five daily readings)
- Score:
- 0
- Reversibility:
- no data
- Remarks on result:
- other: Very well tolerated; Maximum score not reported
- Other effects:
- Cumulative cutaneous irritation index: Concerning the skin response to repeated exposure, the interpretation is more complex because for the series of products tested after several applications, erythema was noted lasting until the final test. This erythema, scarcely visible for the diluted materials, was more serious when the products were tested undiluted. It was also frequently observed that vesicles appeared for spasmodic or prolonged periods, as well as papules, maculae, or patches of erythema. However, if the presence of vesicles is an allergic reaction in the human, it would appear that this is not applicable to the rabbit because in this event 60 to 70% of cosmetics would appear to contain allergy-inducers. It appears that this is due to an occlusive film formed by the remaining material, in spite of all the precautions taken to remove the excess of test substance. The pores in the skin of a rabbit are more dilated than those of human skin and materials tend to accumulate in these cavities. Furthermore, these products, when applied under the same conditions to hairless or normal rats, rarely provoke the appearance of vesicles.
- Interpretation of results:
- other: unable to classify, documentation insufficient for assessment.
- Conclusions:
- Ethylene glycol is not irritating to skin.
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
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- overall irritation score
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Neither the terephthalic acid (202-830-0; 100-21-0) nor ethane-1,2-diol (203-473-3; 107-21-1) metabolites are irritating to the skin. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Neither the terephthalic acid (202-830-0; 100-21-0) nor ethane-1,2-diol (203-473-3; 107-21-1) metabolites are irritating to the skin. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the skin.
- Executive summary:
The in vivo skin irritation of terephthalic acid was assessed in rabbits in a GLP-compliant abbreviated acute dermal irritancy/corrosivity study. No irritancy or corrosivity was observed. Guillot, et al. assessed the in vivo skin irritation of ethylene glycol in a non-GLP-complaint study following the procedure described in the Journal Officiel de la République Française. No irritancy was reported following either single contact or repeated application for 6 weeks. For a substance to produce skin irritation, 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 irritation, it was predicted that BHET will not be irritating to the skin.
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