cis-2-tert-butylcyclohexan-1-ol

Endpoint summary

Description of key information

Skin corrosion: Not corrosive based on an OECD TG 431 test.

Skin irritation: Irritating based on OECD TG 439 test.

Eye irritation: Not irritating based on an OECD TG 438 test.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin corrosion

The potential of Verdol to cause dermal corrosion was also assessed in the EpiDerm skin corrosivity test according to OECD guideline 431. 25 mg of the test item (moistened with 25 μL H2O) were applied directly atop the EpiDerm tissue. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls. The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥50% (96.5%) after 3 min treatment and ≥15% (67.1%) after 60 min treatment.

 

Skin irritation:

The skin irritant potential of Verdol was analysed using the EpiDerm™-Standard Model (EPI-200™). 25 mg of the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls. The test item has no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary. The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 50% (2.9%) after 60 min treatment and 42 h post-incubation. The test item is therefore classified as “irritant”.

 

Eye irritation:

An Isolated Chicken Eye Test (ICET) was performed with the substance according to OECD guideline 438 and in accordance with GLP principles. Thirty mg of the substance was applied to corneas (n=3). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. Slight corneal swelling change (mean = 14.2%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (severity 1 on all three eyes) was observed. No fluorescein retention change was noted on all eyes. No other morphological effect was observed. Based on the results, the endpoints Corneal swelling and Corneal opacity were assigned ICE CLASS II and the Fluorescein retention endpoint was assigned ICE CLASS I. Therefore, the substance is considered as non-irritant.

Justification for classification or non-classification

Based on the results of the available in vitro skin and eye studies, the substance need to be classified as Category 2 skin irritant and not classified for eye irritation according to EU CLP (EC 1272/2008 and its amendments).