Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

No skin sensitization studies with tripropylene glycol were available for assessment. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across.

Reliable studies on skin sensitization were available for assessment for two structural analogues of tripropylene glycol, mono- and dipropylene glycol. For monopropylene glycol, the LLNA test with mice (Basketter et al., 1998), performed according to the standard protocol, resulted in the stimulation index of 1.6 for neat test substance and 1.2 for 50% aqueous solution, indicating that the substance is not a skin sensitizer. For dipropylene glycol, one Buehler test with guinea pigs (Cosmopolitan Safety Evaluation, Inc., 1995), performed under GLP and in accordance with EPA OPP 81-6 (Skin Sensitization) guideline, was available for assessment. No skin irritation was observed at 24, 48 and 72 hours after the challenge, indicating that dipropylene glycol does not possess skin sensitizing properties.

Based on the overall evidence from mono- and dipropylene glycol, it is concluded that tripropylene glycol is not a skin sensitizer. A full justification for read across is contained in a separate document attached to chapter 13 of the lead registrants IUCLID dossier.


Migrated from Short description of key information:
No studies on skin sensitization with tripropylene glycol were available for assessment. However, based on the available data from two structural analogues, mono- and dipropylene glycol, it is concluded that tripropylene glycol does not possess skin-sensitizing properties.

Respiratory sensitisation

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

No data on respiratory sensitization are available. However, in accordance with Section 1 of REACH Annex XI, the study is scientifically unjustified, as respiratory tract sensitization is not expected based on the fact that tripropylene glycol is not skin sensitizer and no human data are available indicating a concern for respiratory sensitization.

Justification for classification or non-classification

No data on skin and respiratory tract sensitizing properties of tripropylene glycol are available. However, based on the data from two structural analogues of tripropylene glycol, mono- and dipropylene glycol, i.e. the stimulation index of 1.6 observed in LLNA study with monopropylene glycol and the absence of skin sensitizing effect in a Buehler study with guinea pigs with dipropylene glycol, as well as the lack of data indicating concern for respiratory tract sensitization, classification according to Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not warranted.