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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In vitro skin corrosion: not corrosive (OECD431)
In vitro skin irritation: irritating (OECD439)
In vitro eye irritation: not irritating (OECD437)

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)

Additional information

- The in vitro skin corrosion study was performed to assess the corrosive potential of Nutmeg oil by means of the Human Skin Model Test (OECD 431). Independent duplicate tissues of the human skin model EST-1000™ were exposed to the test item, the negative control or the positive control. Absorbance measurements of the negative controls confirmed the acceptable quality of the tissues, while the positive control confirmed the validity of the test system. After exposure to Nutmeg oil the relative absorbance values decreased to 89.9% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to 25.9%. Both values did not exceed the threshold for corrosivity of 50% for the 3 minutes exposure and 15% for the 1 hour exposure. Therefore, the test item was not considered to be corrosive.

- The in vitro study was performed according to OECD 439 to assess the irritation potential of Nutmeg oil by means of the Human Skin Model Test. Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes. 10 µL of the test item were applied to each tissue, spread to match the tissue size. After treatment with the test item Nutmeg oil the relative absorbance values decreased to 21.7%. This value is below the threshold for irritancy of ≤50%. Therefore, the test item is considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg oil is irritant to skin and according to EU classification needs to be classified as Irritant (I), R38 (according to Directive 67/548/EEC), and H315 (category 2) (according to Regulation (EC) 1272/2008).

- The in vitro study was performed according to OECD Guideline 437 to assess the corneal irritation and damage potential of Nutmeg oil by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh bovine corneae. The test item Nutmeg oil did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro Score was 2.72 and therefore, the test item was classified as non eye irritant. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Nutmeg oil is not considered to be an eye irritant.

The Respiratory irritation was not tested for Nutmeg oil.

Justification for classification or non-classification

In 2 key in vitro studies, the in vitro skin corrosion test and the in vitro eye irritation test the results were negative for Nutmeg oil, i.e. not corrosive and not irritating, resp. However, in the in vitro skin irritation test Nutmeg oil was considered to be irritating.

Based on the available information, it can not be ignored that Nutmeg oil is found to be skin irritating in one of the two in vitro tests and therefore the substance needs to be classified as such according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) and Annex VI of 67/548/EEC. The substance does not need to be classified for eye irritation.