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EC number: 279-815-0 | CAS number: 81782-77-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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