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Diss Factsheets
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EC number: 201-265-7 | CAS number: 80-26-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: 20-weeks repeated dose toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability 2 is assigned because the information is based on a reliable subchronic repeated dose toxicity study predating OECD Guidelines and GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity
- Author:
- Hagan et al.
- Year:
- 1 967
- Bibliographic source:
- Hagan E.C., Hansen W.H., Fitzhugh O.G., Jenner P.M., Jones W.I., Taylor J.M., Long E.L., Nelson A.A., and Brouwer J.B. (1967) Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity, Food Cosm. Toxicol., 5, 141-157.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- yes
- Remarks:
- Most parameters have been evaluated according to current guidelines but not all.
- Principles of method if other than guideline:
- See repeated dose toxicity section
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- p-menth-1-en-8-yl acetate
- EC Number:
- 201-265-7
- EC Name:
- p-menth-1-en-8-yl acetate
- Cas Number:
- 80-26-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- See repeated dose toxicity section.
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- See repeated dose toxicity section.
- Details on mating procedure:
- Not applicable
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- See repeated dose toxicity section.
- Duration of treatment / exposure:
- 20-weeks
- Frequency of treatment:
- Dietary dosing
- Details on study schedule:
- See repeated dose toxicity section.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
nominal in diet
1000, 2500 and 10000 ppm
- No. of animals per sex per dose:
- 10/sex/dose
Examinations
- Parental animals: Observations and examinations:
- See repeated dose toxicity section.
- Oestrous cyclicity (parental animals):
- No information
- Sperm parameters (parental animals):
- No information
- Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- See repeated dose toxicity section.
- Postmortem examinations (offspring):
- Not applicable
- Statistics:
- See repeated dose toxicity section.
- Reproductive indices:
- Not applicable
- Offspring viability indices:
- Not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- See repeated dose toxicity section.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See repeated dose toxicity section.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- See repeated dose toxicity section.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- See repeated dose toxicity section.
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects were seen on male and female gonads in a 20-week dietary study similar to OECD TG 408, which leads to the conclusion that there are no effects on male and female fertility
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No effects were seen on male and female gonads after 20-weeks of administration of the test substance
- Executive summary:
See repeated dose toxicity section.
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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