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EC number: 240-457-5 | CAS number: 16409-43-1
- 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: subacute
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study according to OECD 407 for repeated dose including reproductive parameters
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) including reproductive parameters
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)) including reproductive parameters
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
- Limit test:
- no
Test material
- Reference substance name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- EC Number:
- 240-457-5
- EC Name:
- Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- Cas Number:
- 16409-43-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- for details see Chapter 7.5.1
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- corn oil
- Details on exposure:
- for details see Chapter 7.5.1
- Details on mating procedure:
- No mating performed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- for details see Chapter 7.5.1
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
- Details on study schedule:
- for details see Chapter 7.5.1
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control:
- not applicable
Examinations
- Parental animals: Observations and examinations:
- for details see Chapter 7.5.1
- Oestrous cyclicity (parental animals):
- Vaginal smears for cycle determination were be prepared in the morning and evaluated for at least 2 weeks.
- Sperm parameters (parental animals):
- Parameters examined in [P] male parental generations:
sperm motility, sperm morphology, sperm head count (cauda epididymis), sperm head count (testis) - Litter observations:
- not examined
- Postmortem examinations (parental animals):
- for details see Chapter 7.5.1
- Postmortem examinations (offspring):
- not examined
- Statistics:
- for details see Chapter 7.5.1
- Reproductive indices:
- not examined
- Offspring viability indices:
- not examined
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
No test substance-related effects on estrous cycle length and the number of cycles were obtained.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
In males of test groups 2 and 3 (300 and 1000 mg/kg bw/d), sperm motility and total sperm head counts in the right cauda epididymidis were decreased, whereas the incidence of abnormal sperms in the right cauda epididymidis was increased.
ORGAN WEIGHTS (PARENTAL ANIMALS)
Significant weight increase (relative +26%, absolute +33%) of the epididymides of males of test group 3 (1000 mg/kg bw/d) was observed.
All other weight parameters concerning primary and secondary reproductive organs did not show test substance related changes, i.e. Adrenal glands, Ovaries, Prostate, Seminal vesicles with coagulating glands, Testes, Thyroid glands, Uterus with cervix
GROSS PATHOLOGY (PARENTAL ANIMALS)
All findings occurred individually. They were considered to be incidental in nature and not related to treatment.
HISTOPATHOLOGY (PARENTAL ANIMALS)
- Epididymis, left
Test group 3: 1000 mg/kg bw/d
o Immature ducts in all males (slight to severe)
o Interstitial edema in all males (minimal to slight)
o Intraductal granulocytic infiltration in 2 of 5 males (minimal)
Test group 2: 300 mg/kg bw/d
o Immature ducts in all males (minimal to slight)
o Interstitial edema in 1 of 5 males (minimal)
Test group 1: 100 mg/kg bw/d
No histopathological changes were found.
- Testis, left
No histopathological changes were found in the left testes.
No test substance related changes were observed in other primary or secondary reproductive organs, i.e. Adrenal glands, Ovaries, Pituitary gland, Prostate, Seminal vesicles, Thyroid glands, Uterus, Vagina
For further information, see Chapter 7.5.1.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: spermatotoxicity, pathology epididymis
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Reprod. organs, estrous cycling
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- other: Effects on parameters addressing reproductive toxicity in F0 males, indicative of adverse effects on F1 offspring.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
In mid/ high dose males sperm function and morphology in the cauda epididymidis were adversely affected.
Histopathology revealed in the left epididymis the presence of immature ducts in the distal corpus and/or cauda epididymis in all mid/ high dose males. Immature ducts increased in severity dose dependently. With increasing severity the immature ducts were accompanied by increasing interstitial edema, which correlated with the significant weight increase found in the high dose group. In only two of five high dose males, additional intraductal granulocytic infiltration was observed in single distended ducts of the cauda with apparent sperm stasis. All of these findings were attributed to treatment and were regarded as adverse.
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