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Diss Factsheets
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EC number: 408-200-3 | CAS number: 63187-91-7 FRESCOLAT MGA
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No screening for reproductive/developmental study was performed. The REACH Annex VIII data requirements are adapted according to column II of the Annex stating that such a study does not need to be conducted if a pre-natal developmental toxicity study is available.
Effects on developmental toxicity
Description of key information
No studies are available that address the toxicity to reproduction of menthon glycerin ketal. In the available 28d repeated dose study on menthon glycerin ketal, no adverse effects were observed in the reproductive organs examined at any of the dose levels.
The two-generation reproductive toxicity study that is available on read-across substance L-menthol did not show any embryotoxic or teratogenic effects at the highest administered dose of 218 mg/kg bw/d.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No studies are available in which reproductive toxicity of the test substance is examined. In stead, a study is available on the read-across substance menthol. The hypothesis supporting the read-across justification is based on the fact that the source chemical, menthol, is formed upon the metabolisation of the target substance, menthon 1,2 -glycerin ketal. This hypothesis is substantiated by the ADME information available on the target and the source chemicals. A complete description of the read-across justification is attached as background material in IUCLID and can be found in the CSR.
A teratologic evaluation of FDA 71-57 (menthol natural, Brazilian) was performed according to unspecified guideline. Twenty-five female Wistar rats per group were assigned to five dosage groups. Virgin adult females were mated with young adult males. Suspensions of the test substance or the vehicle, corn oil, were administered orally via gavage to 0, 2.18, 10.15, 47.05 and 218.0 mg/kg bw/day at a volume of 10 mL/kg on days 6 through 15 of gestation. Detailed clinical observations were performed daily. Body weight was examined on days 0, 6, 11, 15 and 20. The animals were scarified on gestation day 20 and urogenital tract, number of implantations and resorptions were examined. Foetus was weighted per litter. In addition external, soft tissue and skeletal examinations were performed.
There was no cleary discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.
Therefore the NOEL for maternal toxicity and teratogenicity/fetotoxicity is considered to be at 218 mg/kg bw/day of L-Menthol, i.e. the highest applied dose. The NOEL for maternal toxicity and teratogenicity/fetotoxicity extrapolated to menthonglycerin ketal is 318 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
The study available on the read-across substance menthol did not show any adverse effects.
Justification for classification or non-classification
As no toxic effects are observed in the 2 -generation reproductive toxicity study that is available on read-across substance methanol, classification for reproductive toxicity under EU Regulation No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP) or Directive 67/548/EEC (Dangerous Substances Directive) is not required.
Additional information
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.
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