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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
Endpoint summary
Administrative data
Description of key information
Not irritating to the skin or eyes
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- 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.
- 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- 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.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis 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 eye. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the eye.
- 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 eye. Therefore, it was predicted that bis(2-hydroxyethyl)terephthalate (BHET; 959-26-2; 213-497-6) will not be irritating to the eye.
- Executive summary:
The in vivo eye irritation of terephthalic acid was assessed in rabbits in a GLP-compliant abbreviated primary eye irritation study. Virtually no irritation was observed. Carpenter and Smyth (1946) assessed the in vivo eye irritation of ethylene glycol in a non-GLP-complaint study. Minimal to no eye irritation was reported following application of 0.5 mL of undiluted ethylene glycol. The target substance was expected to undergo metabolism by esterases into the two source substances. As in vivo testing for each source substance reported no eye irritation, it was predicted that BHET will not be irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation/Corrosion
The in vivo skin irritation of terephthalic acid (202-830-0; 100-21-0) was assessed in rabbits in a GLP-compliant abbreviated acute dermal irritancy/corrosivity study. No irritancy or corrosivity was observed (OECD SIDS, 2001). Guillot, et al. (1982) assessed the in vivo skin irritation of ethane-1,2-diol (203-473-3; 107-21-1) 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 the target substance will not be irritating to the skin.
Eye Irritation
The in vivo eye irritation of terephthalic acid (202-830-0; 100-21-0) was assessed in rabbits in a GLP-compliant abbreviated primary eye irritation study. Virtually no irritation was observed (OECD SIDS, 2001). Carpenter and Smyth (1946) assessed the in vivo eye irritation of ethane-1,2-diol (203-473-3; 107-21-1) in a non-GLP-complaint study. Minimal to no eye irritation was reported following application of 0.5 mL of undiluted ethane-1,2-diol. The target substance was expected to undergo metabolism by esterases into the two source substances. As in vivo testing for each source substance reported no eye irritation, it is predicted that the target substance will not be irritating to the eye.
Justification for classification or non-classification
Neither of the source substances are classified as either skin or eye irritants according to Europe CLP (EC 1272/2008 as amended). Therefore, the target substance is predicted to not be classified as either an eye or skin irritant according to CLP criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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