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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

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

The key GPMT study (Richeux, 2008) was performed with diglycerol using 12.5% intradermally and 100% topically for induction. After challenge, none of the animals showed a positive response.

In addition, several other studies were available, however, each study showed some deviations, limitations, and thus were considered to be supporting. In a second GPMT Test (Honack, 1996) with diglycerol, guinea pigs were induced with 5% intradermally and 100% topically. None of the guinea pigs showed signs of sensitization after challenge to 100% diglycerol, however the intradermal induction showed no skin reaction at all, and thus a higher concentration should have been used. In a third GPMT test (Chubb, 1997) with 5% diglycerol in water as test substance, guinea pigs were induced with 10% intradermally and 100% topically. After challenge with 100% of the test substance, none of the animals showed a positive response. No test substance information was available. In a fourth GPMT test (Chubb, 1996) with cycl. diglycerol, guinea pigs were induced with 20% intradermally and 100% topically. After challenge with 100% diglycerol, none of the animals showed a positive response. In a fifth GPMT test (Karunaratne, 1996) with diglycerol, guinea pigs were induced using 20% intradermally and 100% topically. After challenge with 100% diglycerol, three animals showed a positive response (30%), while none in the control group showed a response. As 30% is the limit value for considering a substance as sensitizing, it is strongly recommended according to OECD 406 to use 20 test animals and 10 control animals in this test, instead of 10 test and 5 control animals.

All tests were performed using Freund's Complete Adjuvant and sodium lauryl sulphate as prescribed by OECD 406. Thus animals were sufficiently induced.

In addition, a human patch test has been performed, showing no skin sensitisation after induction and challenge with diglycerol.

Based on the above information, the overall conclusion is that diglycerol is not sensitizing to skin.

Migrated from Short description of key information:

Four GPMT tests with diglycerol and one GPMT test with cycl. diglycerol are available. The tests have all been performed according to OECD 406 and GLP. In addition, a human patch test was available. Although one animal test showed a positive response (30% response), the overall conclusion is that diglycerol is not sensitizing to skin.

Justification for classification or non-classification

In view of the test results described above, diglycerol does not need to be classified for skin sensitization according to CLP Regulation (EC) No. 1272/2008.