Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate

Endpoint summary

Description of key information

Skin irritation: the substance does not cause skin irritation based on OECD TG 439

Eye irritation: not irritant based on OECD TG 438

The substance is not a skin or eye irritant and therefore it is not likely to be a respiratory irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

In a study, performed according to OECD TG 439 and in compliance with GLP, the test substance was examined for its potential to cause in vitro skin irritation using the EpiDerm™ reconstructed skin membranes. The EpiDerm™ skin membranes were topically exposed to one dose level of the test substance (30 μL undiluted) for 1 h. After culturing for 42 h the viability of the epidermal cells was assessed using the MTT test. The general principle for the detection of viability via the MTT test is the conversion of the yellow tetrazolium salt (MTT) to the blue/purple coloured product formazan by mitochondrial enzymes. The formation of formazan was measured using a spectrophotometer. Phosphate-buffered saline and 5% sodium dodecyl sulphate were used as positive and negative control, respectively. Mean tissue viability of the positive control was 6%. Tissue viability following exposure to the substance was 93± 10% (mean ± SD) compared to the negative control. As this value was above the limit value of 50%, the substance was considered to be non-irritating to human skin.

Eye irritation

In a study, performed according to OECD TG 438 and in compliance with GLP, the substance was evaluated for eye irritation potential in the Isolated Chicken Eye (ICE) test. ln addition, the test included a negative control (saline) and a positive control (BAC 5%). Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of 30 µL of the test sample for 10 seconds followed by a 20 mL saline rinse. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells. The substance caused very slight swelling of the cornea, slight or slight to moderate corneal opacity, and very slight or slight fluorescein retention. The calculated Irritation Index was 43 (max possible score is 200). The negative control (saline) caused no corneal effects. The positive control BAC 5% caused moderate corneal swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 145. Based on the results of this in vitro study, the substance is considered not to be an ocular corrosive or severe irritant.

Respiratory irritation

For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3). There are no human data such as indicated in R7.2.3 of the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. In addition, the substance is not corrosive or severely irritating which further minimizes the respiratory irritation hazard (REACH guidance: 7.2.1.2).

Justification for classification or non-classification

Based on the negative results of the available studies, classification of CP Formate for skin, eye or respiratory irritation is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and its amendments.