Reaction mass of 2,6-Octadien-1-ol, 3,7-dimethyl-, (E) and 2,6-Octadien-1-ol, 3,7-dimethyl-, (Z)-

Endpoint summary

Description of key information

Repeated Dose Toxicity:
- NOAEL: 10000 ppm > ca. 550 mg/kg bw/day (112 days)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

550 mg/kg bw/day

Additional information

Oral

No data concerning the repeated dose toxicity of the reaction mass of geraniol and nerol is available. However, the oral repeated dose toxicity was evaluated in a study (Hagan, 1967) with a mixture of 3,7-dimethyl-2,6-octadienol and 3,7-dimethyl-1,6-octadienol (named "Geraniol extra" by the authors). Due to the structural analogy, this study is used for read across, expecting the reaction mass of geraniol and nerol to have similar effects.

The test substance was feed to five male and five female individually housed Osborne-Mendel rats per dose group. Thereby, a concentration of 1000 ppm (= ca. 55 mg/kg bw/day) was administered for 189-169 days and a concentration of 10000 ppm (= ca. 550 mg/kg bw/day) was given for 112 days. During the study, the food consumption was monitored and blood was collected at the end of study and was subjected analysis of white cell counts, red cell counts and hemoglobin and hematocrit content. Also, animals were necropsied and histopathology was performed. Since no clinical signs, no effects on body weight as well as no histopathological changes were observed, the NOEL could be estimated as 10000 ppm. Thus the NOAEL would be > 550 mg/kg bw/day.

In another study, ten rats per dose were fed with 0.1% geraniol for 28 weeks and with 1% for 16 weeks (FDA, 1954). Since no effects were reported, a NOEL of 1% could be estimated. However, this data could not be considered for assessment since only concentrations of 1% and 0.1% were used and only limited data were given.

Inhalation

In an inhalative repeated-dose toxicity study, eight complex fragrance mixtures consisting of approximately 200 ingredients (close to one-half of the ingredients present at a level of 1% or more) were tested (Fukayama, 1999). Geraniol was present in 3 out of the eight mixtures and was tested in Syrian hamster and CD and Sprague-Dawley rats. They were whole-body exposed to the mixtures at 5, 9 or 50 mg/m³ for 4 h/day, 5 days/week for 6 or 13 weeks. The concentrations of fragrance in the chamber used were monitored and the found particle size ranged from 0.5 to 4.3 µm. Thereby, the highest determined exposure levels were 5.7 and 37.8 µg/m³. No gross pathological or histopathological findings related to test material exposures were observed. However, because different mixtures of substances were used in this study, the data could not be taken into account for assessment.

Justification for classification or non-classification

Based on the results from repeated dose toxicity testing no classification for specific target organ toxicity after repeated exposure is warrented according to Regulation (EC) No 1272/2008.