4-methyl-3-decen-5-ol

Endpoint summary

Description of key information

Oral Toxicity:
Weight of evidence: No adverse effects, NOEL 10,000 ppm (equivalent to 10,000 mg/kg diet), 16 week feeding study (rat), Hagan et. al. 1996 (reaction mass of geraniol and linalool).
Weight of evidence: No adverse effects, NOEL 1,000 ppm (equivalent to 1000 mg/kg diet), 27-28 week feeding study (rat), Hagan et. al. 1996 (reaction mass of geraniol and linalool).
Inhalatory and Dermal Toxicity:
As the oral route was considered a likely route of exposure that would deliver a systemic dose representative of a worst case scenario, testing via the inhalatory and dermal routes were considered inappropriate.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

chronic

Species:

rat

Quality of whole database:

The quality of the dataset is considered high, and the data sufficient to address this endpoint.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral Toxicity

The subchronic oral toxicity of 4-methyl-4-decen-5-ol has been assessed using the analogous substance geraniol extra, a reaction mass of geraniol and linalool (3,7-Dimethyl-2,6-octadienol and 3,7-Dimethyl-1,6-octadienol).

Two separate studies, reported in the same publication (Hagan, 1996), have been provided as a weight of evidence. The individual studies were conducted as part of a screening study on 48 food flavourings. Both studies follow a similar methodology, where the first study was conducted at 10,000 ppm for 16 weeks, and the second at 1000 ppm over 27-28 weeks. Rats were exposed to the test material in a feeding study, where prepared diet was provided ad libitum over the designated exposure period. General condition, bodyweight and food consumption were recorded on a weekly basis. At termination blood samples were collected for haematology examination. Subsequently all rats were sacrificed for gross necropsy and histopathology. A control group was run concurrently.

Under the conditions of both tests, no treatment related effects on growth, haematology, macroscopic or microscopic changes in tissue were noted in any of the exposed animals. Since no effects were observed the NOELs were determined to be the maximum concentration tested, 10,000 and 1000 ppm (equivalent to 10,000 and 1,000 mg/kg diet, respectively) in the 16 and 27 -28 weeks studies respectively.

Important considerations for the use of read-across for repeated dose toxicity are: i) 4-methyl-3-decen-5-ol (the target substance) has similar physico-chemical properties to Geraniol Extra (a reaction mass of Geraniol (2E)-3,7-dimethylocta-2,6-dien-1-ol and Linalool 3,7-dimethylocta-4,6-dien-3-ol (the source substance), ii) there are structural similarities between the two chemicals and iii) the OECD QSAR Toolbox assigns an identical toxicity profile to both chemicals. The source substance is therefore considered suitable for classification and labelling and risk assessment purposes using a read-across approach.

Inhalatory and Dermal Toxicity:

In accordance with point 8.6.1 and 8.6.2, column 1 and column 2 of Annexes VIII and IX, respectively, of Regulation 1907/2006, testing for this endpoint should be performed using an appropriate route of exposure. The oral route is considered a likely route of exposure, one that would deliver a systemic dose representative of a worst case scenario, testing via the inhalatory and the dermal route were therefore considered inappropriate.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
One study could not be selected as key as both are from the same report and of equal quality, furthermore, no distinguishable differences could be noted between the effects of a higher dose level vs. a longer exposure period. The studies were performed using the analogous substance geraniol extra, a reaction mass of geraniol and linalool (3,7-Dimethyl-2,6-octadienol and 3,7-Dimethyl-1,6-octadienol). The investigations were performed in line with generally accepted scientific principles, with a sufficient level of reporting to assess the quality of the submitted data. Accordingly the studies have been assigned a reliability score of 2 in accordance with the criteria defined in Klimisch (1997).

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Data waivers have been submitted to address repeated dose toxicity via the inhalation route.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Data waivers have been submitted to address repeated dose toxicity via the inhalation route.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Data waivers have been submitted to address repeated dose toxicity via the dermal route.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Data waivers have been submitted to address repeated dose toxicity via the dermal route.

Justification for classification or non-classification

In accordance with the criteria for classification in Directive 67/548/EEC and the guidance provided for determining classification as outlined in Regulation No. 1272/2008, the substance does not require classification for repeated dose toxicity or specific organ toxicity after repeated exposure.