A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]

Endpoint summary

Description of key information

Skin sensitisation: no skin sensitiser based on testing in OECD TG 406.

Respiratory sensitisation: the substance is not a respiratory sensitiser in absence of human data and in absence of skin sensitisation from an animal test.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

GPMT:

The substance was tested in a guinea pig maximisation test (OECD TG 406) using ten animals and five control animals. The concentrations were selected based on the results of a preliminary study. In the induction phase, the substance was tested both through intradermal injections at a concentration of 7.5% in Alembicol D as well as through topical application using the test substance as supplied. In the challenge phase, the substance was tested as supplied and at a concentration of 50% in Alembicol D. No signs of illness or toxicity were observed. Bodyweight increased as expected during the period of the study. In the induction phase, necrosis was observed in both test and control animals after intradermal injections of Freund's Complete Adjuvant. Slight irritation was seen in test animals after receiving the test substance, 7.5% v/v in Alembicol D and very slight irritation was seen in control animals after receiving Alembicol D without test substance. Topical application of the substance as supplied resulted in very slight erythema in test animals. Slight erythema was also observed in control animals. In the challenge phase, no reactions were observed in any of the test or control animals except for dryness and sloughing of the epidermis in one test animal 48 and 72 hours after the challenge phase. The degree and duration of this reactopn was not considered to represent evidence of skin sensitisation. Based on the results obtained in this study, the substance is not sensitising to the skin.

 

HRIPT

In addition to the GPMT test, a HRIPT study with the substance is available. However, because the substance did not induce dermal reactions and because it is also no skin sensitiser in the GPMT this information is not used for further assessment and therefore not further described in detail.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Respiratory sensitisation can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2015) that indicate respiratory reactions e.g. from consumer experience or occupational exposure. In case no sich data are available the respiratory sensitisation can be assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3 -4, 2017), which says that if the substance is not a skin sensitiser, it is unlikely to be a respiratory sensitiser.

Justification for classification or non-classification

The substance is not sensitising to the skin and therefore it does not have to be classified for skin sensitisation in accordance with EU CLP (EC no. 1272/2008 and its amendments).