3,7-dimethyloctan-1-ol

Endpoint summary

Description of key information

Acute oral toxicity: non-toxic after single oral administration (Shelanski 1973)
Acute dermal toxicity: of low acute toxicity after single dermal administration (WoE).

Additional information

Acute oral toxicity:

In the key study for acute oral toxicity of tetrahydrogeraniol, ten rats were administered with 5000 mg/kg bw tetrahydrogeraniol (Shelanski, 1973). Since no mortality was noted within the 14 days observation period the LD50 was determined as >5000 mg/kg bw.

Therefore, tetrahydrogeraniol is considered non-toxic after single oral administration.

Acute inhalative toxicity:

No data are available for acute inhalative toxicity of tetrahydrogeraniol. For the coverage of a second and human relevant route of exposure, data on acute dermal toxicity are available. Based on the available acute oral and dermal data, no acute inhalative toxicity for tetrahydrogeraniol is indicated.

Acute dermal toxicity:

In an acute dermal toxicity study in rabbits according to guideline section 191.10 of the Final Order, Enforcement Regulations 0.25, 0.5, 1, 2 or 4 ml/kg bw tetrahydrogeraniol was applied to the abraded skin of two rabbits and to the intact skin of two additional animals (Shelanski, 1973a). As a result, a LD50 of 2.4 ml/kg bw was calculated. Based on the limited documentation it is unclear if the LD50 calculated refers to undiluted dimethyl-1-octanol or a formulation containing 8% dimethyl-1 -octanol.

In an acute dermal toxicity study in rabbits, a dose of 5000 mg/kg bw tetrahydrogeraniol was applied to six rabbits resulting in lethargy, malaise, prostration, coma and mortality in 4 of 6 animals. The LD50 has been set at <5000 mg/kg (Shelanski, 1973b).

 

Further information on acute dermal toxicity 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 respective dermal toxcity study available from secondary sources being cited in a peer reviewed publication, tetrahydrolinalool was administered to 10 rabbits (Moreno 1976). The LD50 was reported to be >5000 mg/kg bw.

 

In addition, according to the OECD SIDS for members of the Oxo Alcohols C9 to C13 Category being structurally similar to tetrahydrogeraniol, oral LD50s ranged from > 2000 to 5400 mg/kg bw and dermal LD50s ranged from > 2600 to 5010 mg/kg bw (SIDS INITIAL ASSESSMENT PROFILE, attached to 7.12).

Overall in a weight of evidence, tetrahydrogeraniol is considered to be of low acute toxicity after single dermal application.

Justification for classification or non-classification

The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted. According to UN-GHS, the test substance needs to be classified as acute dermal toxicant (Category 5).