Registration Dossier

Administrative data

Description of key information

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 (irritating)

Additional information

Skin irritation:

three studies performed on animals and one on human volunteers were available. Only one was performed on rabbits was considered as reliable (reliability 2 according to Klimish ranking) and was selected as a key study. In this study (Haynes, 1988), four New-Zealand White female rabbits were dermally exposed to 0.5 ml of guaiacol for 4 hours to left flank (6 cm square). Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize. In this study, guaiacol was slightly irritating.

Moreover, guaiacol was tested in a international prevalidation study (Fentem et al.,1998) on in vitro tests forreplacing the in vivo rabbit test  for skin corrosivity conducted during 1996 and 1997under the auspices of European Centre for the Validation of Alternative Methods (ECVAM) (see section 7.12).

Eye irritation:

Two studies were available. Only one was considered as reliable (Reliability 1according to Klimish) and was considered as a key study.

In this study (CERB, 2006), 0.1 ml of gaiacol (99.6% of purity) was instilled into the conjunctival sac of left eye of adult New Zealand White rabbits (female). Eyes were not rinsed and the other eye served as control.
Animals then were observed for 14 days. Irritation was scored by the method in accordance with EU and OECD guidelines, and results gave "slightly irritating" and should not be classified as irritating.

Respiratory irritation:

No data available.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

The available studies selected as key studies showed that guaiacol is slightly irritating for skin and eye rabbits and should not be classified for these endpoints based on the calculated scores and according to the Directive 67/548/EEC annex VI and to the Regulation (EC) n°1272/2008 annex I.

However, guaiacol is officially classified as Irritant for the eyes and skin (Xi R36/38), in the Regulation (EC) n° 1272/2008 annex VI table 3.2 and as Eye Irrit. and Skin Irrit. Category 2 (H319: Causes serious eye irritation - H315: Causes skin irritation) according to the Regulation (EC) n° 1272/2008 annex VI table 3.1.