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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Not sensitising to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Justification for classification or non-classification

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.  According to European CLP (EC 1272/2008 as amended), BHET (959-26-2; 213-497-6) was not classified as sensitising to skin.