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 irritation (OECD TG 404): the substance causes skin irritation.

Eye irritation (OECD TG 405): the substance causes eye irritation.

Respiratory irritation: the substance causes no respiratory irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

The substance is tested in an in vivo acute dermal irritation test (OECD TG 404). An amount of 0.5 mL was applied in a semi-occlusive manner to the clipped skin of 3 New Zealand White female rabbits. Exposure time was 4 hours after which skin reactions were observed for 13 days. Very slight to well-defined erythema with very slight to slight oedema was seen in all three animals following removal of the dressings. These reactions increased in severity, and well-defined to severe erythema with blanching and/or necrosis and very slight to moderate oedema was observed. The reactions gradually ameliorated and had resolved completely by Day 6, 9 or 13. Average scores over the observation period were 2, 2 and 4 for erythema and 2, 3 and 1 for oedema. There were no signs of toxicity or ill health in any rabbit during the observation period. Based on these results, the substance causes skin irritation.

 

Eye irritation:

The substance is tested in an in vivo acute eye irritation study (OECD TG 405). Three female rabbits were exposed to the substance for a duration of 1 hour using a single application of 0.1 mL. The treatment was followed by an observation period of 14 days. No corneal damage or iridial inflammation was observed. Redness and chemosis were observed (scores 2, 2 and 3 for redness and scores 2, 3 and 3 for chemosis) increasing in severity from 1 hour to 3 days in one animal and from 1 hour to 7 -14 days after installation in the other two animals. There were no signs of toxicity or ill health in any rabbit during the observation period. Based on these results, the substance causes serious eye irritation.

 

Respiratory irritation:

There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The ECHA guidance (R7a: 7.2.12.1, 2017) presents that respiratory irritation may be indicated when the substance is a severe irritant. The substance is a skin irritant but not corrosive, it is an eye irritant (Cat 2) but in absence of human data the substance does not need to be classified as a respiratory irritant. Also the substance has a low vapour pressure (1.5 Pa) which minimises the exposure via the inhalation route.

Justification for classification or non-classification

The substance has to be classified as skin irritation category 2 and eye irritation category 2 and shall be labelled with H315: Causes skin irritation and H319: Causes serious eye irritation according to EU CLP (EC no. 1272/2008 and its amendments).