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Diss Factsheets
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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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of the substance was evaluated on the basis of the results of two valid key studies.
Givaudan (1980b) determined the skin sensitisation potential of the test material in an open epicutaneous test in the guinea pig. A preliminary test was conducted to define the test concentrations for the definitive test; the maximum non-irritating and minimum irritant concentrations. In the definitive test, guinea pigs received daily topical induction applications of the test material in solution with ethanol at 100, 30, 10 and 3% for 21 consecutive days. A 0.1 mL aliquot of the appropriate test solution was applied to an area 8 cm² located on the flank of each animal and left uncovered. Each animal was challenged on the untreated flank on days 21 and 35 with a 10% of less test solution. The sensitisation potential was scored 24, 48 or 72 hours after challenge. Under the conditions of the test, the highest non-irritating concentration after a single application of the test material in ethanol was 10%. Only very slight skin irritation occurred with repeated applications. None of the tested animals elicited a positive reaction to the challenge exposure. Accordingly the test material was considered to be non-sensitizing.
Harrison (1981) determined the skin sensitisation of the test material in human volunteers in a repeat insult patch test (HRIPT). Forty human volunteers were exposed to the test material in a repeated insult patch test at a concentration of 10 %. Under the conditions of the test, no reactions were observed in any of the exposed volunteers and thus the test material was determined to be non-sensitising.
Both studies were performed to sound scientific principles and were assigned reliability scores of 2 in accordance with the principles for assessing data quality as set out by Klimisch (1997). Both studies provide sufficient information to assess the skin sensitisation of 4-methyl-3-decen-5-ol and a conclusion of non-sensitising to the skin was carried forward for risk assessment.
Migrated from Short description of key information:
Key study: None sensitising, open epicutaneous test (guinea pig), Givaudan. 1980b.
Key study: None sensitising, HRIPT (human), Harrison (1981)
Justification for selection of skin sensitisation endpoint:
The key study Anon. (1980) was submitted to fulfil the data requirements of this endpoint. This study pre-dates GLP and was performed to sound scientific principles following the open epicutaneous test methodology. The report includes sufficient detail to assign the study a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-sensitising.
The key study Harrison (1981) was submitted to fulfil the data requirements of this endpoint. The study was performed to sound scientific principles and was followed the HRIPT (Human Repeat Insult Patch Test) methodology). The report includes sufficient detail to assign the study a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-sensitising.
The endpoint was therefore addressed in line with the provisions detailed in Annex XI of REACH (Regulation EC 1907/2006) which states that historical human data shall be considered.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the EU Regulation EC 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for skin sensitisation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.