Bis(hydroxyethyl) terephthalate

Endpoint summary

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

Reference

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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.