Registration Dossier

Administrative data

Description of key information

- Irritation
Skin: irritant for rabbit skin (OECD 404)
Eye: irreversible effects on the rabbit eye (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Additional information

Skin Irritation

Animal Data

The irritation to skin by 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 could be regarded as irritant to skin.

In another study performed according OECD guideline 404, intact skin of three New Zealand white rabbits as applied with two types of geraniol (Geraniol 5020 and Geraniol 980) under semiocclusive conditions for 4 h (BBA, 1987). As a result, the primary dermal irritation index (PDII) was found to be 3.8 for Geraniol 5020 and 2.2 for Geraniol 980.

A Draize-test was conducted with 12 angora rabbits, where 0.1 g of geraniol besides two other substances was applied to clipped skin under occlusive conditions for 24 h (Motoyoshi, 1979). The resulting effects was and PDII of 3 after 48 h. In the same study, six Hartley guinea pigs and six Pitman-Moore improved strain miniature swines were also tested and PDII of 3 was found in guinea pigs whereas in miniature swine no irritation was noted (Motoyoshi, 1979).

In addition to the described studies, several other publications and studies by companies showed that geraniol is irritant to skin (Sharp, 1978; Haynes, 1984, 1985, 1986; Klecak, 1977; Troy, 1977; Givaudan, 1977; Buehler, 1992; Givaudan, 1977; Quest International, 1980, 1989). Because of this pronounced irritant effects, geraniol was also used as a positive control in numerous skin irritation studies with other substances performed by Quest International.

Besides this, skin irritation was also tested in a direct topical application test and patch test on the SkinEthic Model reconstituted human epidermis (Tornier, 2006). Since in both test types low cell viability, necrosed histology and an increase of the amount of IL-1alpha was detected, geraniol was regarded as irritant to skin.

Human Data

When geraniol was tested with human volunteers, a concentration of 32% applied for 48 h induced severe skin irritation when evaluated 30 min after patch removal (Motoyoshi, 1979).

In another study, 0.2 ml was a applied progressively from 15 and 30 minutes through 1, 2, 3 and 4 hours to the upper arm of 25 volunteers (York, 1996). In two subjects severe irritation effects were observed after the 4 h exposure period.

Concentrations of 0.5%, 2% and 20% did no cause any irritation to the skin of 84, 30 and 29 subjects, respectively (Fujii, 1972).

In summary, geraniol could be regarded as irritant to skin as demonstrated in numerous animal studies. The grade of severity could be thereby linked to the concentration used as observed in the studies with human. 

Eye Irritation

Irritation to eyes by geraniol was evaluated in a study performed according to OECD guideline 405 and EU method B.5 (Haarmann und Reimer, 2000). 0.1 ml of pure geraniol was administered into the right eye of four SPF albino rabbits and reactions were monitored for 21 days. Well defined signs of irritation were observed on the treated eyes, including cornea opacity, iris lesion, crimson red conjunctiva and swelling of the conjuctiva, while they were not reversible in two out of four animals after the observation period. Thus, geraniol could be regarded as eye damaging (irreversible effects on the eye).

In another study, a Draize-test was performed where 0.1 ml of geraniol was applied into the eyes of six rabbits (Troy, 1977). Irritant effects were noted during the observation period of seven days, so geraniol was regarded as irritant to eyes.

When geraniol at a concentration of 12.5%was instilled into the eye of three albino rabbits, no corneal opacity or iris congestion was observed, but an intense conjunctival irritation was observed involving chemosis and discharge (IFF, 1963). In the same study, only a mild conjunctival irritation was noted, when a concentration of 5% was used.

Thus, geraniol could be regarded as eye damaging due to results in studies including a study performed according to OECD guideline.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irreversible effects

Justification for classification or non-classification

Due to results of studies for skin irritation and for eye irritation performed according to OECD guidelines, Geraniol has to be classified according to Regulation (EC) No 1272/2008 as irritant to skin Cat. 2 (H315) and as eye damaging Cat 1 (H318).