Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD TG 404, GLP): irritating (Bush Boake Allen 1989)
Eye irritation (WoE): irritating

Key value for chemical safety assessment

Additional information

Skin irritation:

In the key study for irritation to skin performed in compliance with OECD guideline 404 and GLP, 0.5 ml of undiluted tetrahydrogeraniol was applied to the clipped dorsal skin of three New Zealand white rabbits under semiocclusive condition for 4 hours (Bush Boake Allen 1989). The mean scores (24, 48, 72 hours) was 2, 1.7, 2 for erythema and 1, 1, 1 for edema for animal 1, 2, 3 respectively. Two of 3 animals showed a grade 1 erythema at the end of the observation period (14 days). Thus, tetrahydrogeraniol was found to be irritating to skin.

 

Eye irritation:

An in vitro eye irritation test on bovine eyes, similar to the BCOP test is available (Frey-Tox 2000). 0.5 mL of undiluted tetrahydrogeraniol was applied to the corneas of 4 bovine eyes. After an incubation period of 30 seconds, the test item was rinsed off and corneas were analysed for corneal damage. Very slight to slight reactions have been observed. Test substance is an alcohol, representing a structural class being prone to be false positive in the BCOP.

Further information on eye irritation can be derived from a structurally similar substance, i.e. tetrahydrolinalool (CAS 78-69-3). Both substances share the same functional groups, belong to the group of the saturated branched chain alcohols and are similar in their chain length, giving confidence in chosing tetrahydrolinalool for read across.

In the available key study for tetrahydrolinalool, a Draize test was performed with 2 White Vienna rabbits (BASFAG XXVI402). Eyes were left unwashed after application of 0.05 ml undiluted tetrahydrolinalool and the animals were observed for 8 days. The mean score (24 and 48 h reading; all animals) was 1.5 for conjunctiva redness; 0.75 for chemosis and 1.0 for corneal opacity. Iritis was not observed. Conjunctiva redness was not reversible at the end of the observation period of 8 days in both animals.

In addition, according to the OECD SIDS for members of the Oxo Alcohols C9 to C13 Category being structurally similar to tetrahydrogeraniol, these structures were moderately irritating to the skin of rabbits and generally irritating (range: non-irritating to severely irritating) to the eyes of rabbits.

Overall in a weight of evidence, tetrahydrogeraniol is considered to be irritating to eyes.

Respiratory irritation:

No data available

Justification for classification or non-classification

Based on the erythema scores of 2 in 2/3 animals and the erythema found at the end of the observation period (14 days) in 2/3 animals, the present data 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. According to 1272/2008/EEC, a classification as "eye irritant" (Category 2A) is warranted.