Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Skin irritation

No key study is available for geranyl acetate. In a skin irritation test in rabbits not according to current guidelines, geranyl acetate was applied open to the clipped skin of 6 rabbits for 24 hours (Motoyoshi, 1979). 30 min after first reading, the skin was clipped again and a new application of geranyl acetate followed. Another reading was then done 48 h after the start of 2nd exposure. Intravenous injection of Evans Blue was made and 1 h after injection dorsal skin was removed to asses dilating rate and capillary permeability. Primary irritation index was determined as the total of the averages of reddening rate (erythema, 72 hours reading) + dilating rate (of blood vessels) + swelling rate (edema) + blueing rate (as a result of increased capillary permeability). Geranyl acetate was reported to be severely irritating (no further data given).

Further skin irritation data from a structurally and metabolically related substance, i.e. geraniol (CAS 106-24-1) give further indications for a the skin irritating potential of geranyl acetate. The skin irritation potential of geraniol was analyzed in a study with three experiments performed according to OECD guideline 404 as stated in the ECETOC Technical Report No. 66 (Givaudan, 1995). In these experiments, 0.5 ml of geraniol was applied to three to four rabbits for 4 h and the application site was observed the following 7 days. Resulting erythema and edema were scored 24, 48 and 72 h later, as well as 7 days after application and scored according to Draize. The results were erythema scores of 2, 2.08 and 1.92 and edema scores of 1.67, 1.25 and 1 in the experiments 1, 2 and 3, respectively. Since the irritation effects were still apparent and desquamation was noted at the end of observation time geraniol is regarded as irritating to skin.

Overall in a weight of evidence, geranyl acetate is considered to be irritating to skin.

Eye irritation

No key study for eye irritation is available for geranyl acetate. However data from the structurally related respective stereoisomer (nerylacetate; CAS 141 -12 -8) are taken into account for assessment.

In the chosen key study for eye irritation according to OECD TG 405 and GLP, 0.1 ml of undiluted neryl acetate was instilled into the eyes of four SPF albino rabbits (Symrise, 2000). The resulting mean scores for corneal opacity, iritis, conjunctival redness and chemosis (24 - 72 h readings over all animals investigated) were 0, 0, 0.4 and 0.3, respectively. The findings were fully reversible within 72 hours.

Overall, based on the findings for the stereoisomer neryl acetate, geranyl acetate was found to be not irritating to eyes. 

Justification for classification or non-classification

The present data on skin irritation fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and a classification "irritating to skin" (R38) and "skin irritant" (category 2) is warranted.

The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.