Registration Dossier

Administrative data

Description of key information

Skin irritation: Read across within citrus oils and major constituent limonene: irritating
Eye irritation: Read across within citrus oils and major constituent limonene: not irritating

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 irritation

Three in vivo skin irritation studies with grapefruit, lemon and lime oil showed that these NCSs should be considered irritating, although these studies were not conducted according to the guideline (only one time point was included). The study with orange oil should be classified as skin irritating according to the French DSD classification system, but according to CLP Orange oil in this study would be classified as not skin irritating.

 

A study with D-limonene showed that this major constituent was irritating to the skin. D-limonene is also classified with R38. As D-limonene is present in all NCSs at levels higher than the thresholds mentioned for classification and labeling (in both 68/548/EEC and 1272/2008/ECand three studies showed evidence of skin irritation, these results were read across to the other NCSs: The whole citrus NCS group is considered to be irritating to the skin.

 

Eye irritation

Two in vivo eye irritation studies with orange and lemon oil showed that these NCSs are not irritating to the eye. A study with D-limonene showed that this major constituent also was not irritating to the eye. These results are read across to the other citrus NCSs and the whole group is considered non-irritating to the eye.This read across is considered valid because of:1) the similar origin of the oils in this group, 2) the dominant presence of D-limonene in all oils of this group, 3) the same and similar other constituents.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available information, the substance mandarin oil needs to be classified for skin irritation according to the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS).

Based on the available information, mandarin oil does not need to be classified as eye irritant according to the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS).