2,6-Octadienal, 3,7-dimethyl-, acid-isomerized

Endpoint summary

Description of key information

Skin irritation/corrosion

For skin irritation and skin corrosion there is one key in vitro study available each. Both studies were performed according to their respective OECD guidelines and in compliance to GLP.

Under the experimental conditions reported, the test item is irritant to skin but is non corrosive.

Eye irritation

For eye irritation there is one key in vivo test available. The in vivo study (1984) was performed according to OECD guideline 405 but not according to GLP (pre-GLP).

The test item is not irritant to the eye in the key in vivo study.

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

One key in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. The test was according to OECD 439 and GLP.

Compared to the relative absorbance value of the negative control the mean relative absorbance value was reduced to 37.4% after exposure of the skin tissues to the test item, which is below the threshold for irritancy of ≤ 50%.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is irritant to skin.

One key in vitro study was performed to assess the corrosive potential of the test item by means of the Human Skin Model Test with EpiDerm™ tissues models. The study was performed in compliance to OECD TG 431 and GLP.

Independent duplicate tissues of EpiDerm™ were exposed to either the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively.

After exposure of the tissues to the test item the corrected relative absorbance value did not decrease (101.1%) after 3 minutes exposure as well as after 1 hour exposure (119.7%,corrected value).

Since the thresholds for corrosivity are defined to be 50% after the 3minutes exposure and 15% after the 1 hour exposure, the test item is not considered to be corrosive.

Ski Eye irritation

The key study (1984) evaluated the eye irritant effects of the test item according to OECD 405.

100% of the test item was applied to the right eye of 3 rabbits, while the left served as control. Reactions were read 1, 24, 48 and 72 hours after treatment.

The test material caused irritation in all rabbits 1 hour after application. After 24 hours only 2 animals showed mild conjunctival inflammation, however, the reactions were fully reversible.

The calculated mean scores at 24, 48 and 72 hours for the 3 animals were 0.0 for the cornea, 0.0 for the iris, 0.2 for the conjuctival redness and 0.0 for conjunctival chemosis.

The substance is not irritant to the eye and should not be classified.

Justification for classification or non-classification

Skin irritation/corrosion

In conclusion, it can be stated that under the reported experimental conditions and according to EU CLP regulations, the test item is irritant to skin and should be classified as category 2 (irritant) and the test item is non corrosive to skin and does not need to be classified as corrosive.

Eye irritation

The criteria to classify a substance for eye irritation are set out in Table 3.3.1 and Table 3.3.2 of the EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP).

Accordingly, test item is not irritant to the eye in the key in vivo study (1984) and does not need to be classified.