Registration Dossier
Registration Dossier
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EC number: 916-331-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Cyclabute is non-sensitising based on a GPMT (OECD TG 406) test.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
This Guinea Pig Maximization Test (OECD 406) was performed to determine the sensitising potential of Cyclabute in guinea pigs. Prior to the sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test. For the main test, 10 guinea pigs were first induced by intradermal injections (with a concentration of 0.8% Gardocyclene (as named in the report. It is another name for Cyclabute) and topical application (with a concentration of 100% Gardocyclene). The selection of the final challenge concentrations were based on intradermal and topical effects seen at 1% and 100%. In view of this slight irritation at 100%, the animals were subjected to 2 challenges with 50% and 25% solutions of Cyclabute in acetone/PEG, respectively. At 24 and 48 hours after the challenge the treatment sites were examined and scored for erythema, oedema, and necrosis. The grade of erythema and possible oedema and necrosis determine the possible sensitizing properties of the test substance. For Cyclabute only very faint erythema was observed. Based on this study, Cyclabute does not trigger a sensitization reaction in albino Dunkin/Hartley guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Cyclabute is not a respiratory sensitiser because it is not a skin sensitiser. This conclusion is derived using the ITS on respiratory sensitisation in the ECHA guidance (R7A, Fig. 7.3-4) (2017)
Justification for classification or non-classification
Based on the available information, the substance Cyclabute does not need to be classified for skin and respiratory sensitisation based on the criteria of EU-CLP (1272/2008 and its amendments).
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