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Diss Factsheets
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EC number: 252-036-3 | CAS number: 34451-19-9
- 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:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- SIDS Initial assessment reports for SIAM 13 - n-Butyl Alcohol (CAS Nr 71-36-3)
- Author:
- OECD SIDS
- Year:
- 2 001
- Bibliographic source:
- https://hpvchemicals.oecd.org
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
The potential testicular toxicity of n-butyl acetate was examined in a 14-weeks inhalation study with male rats.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-butyl acetate
- EC Number:
- 204-658-1
- EC Name:
- N-butyl acetate
- Cas Number:
- 123-86-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- butyl acetate
Constituent 1
- Specific details on test material used for the study:
- no specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 6 hours per day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Remarks:
- Control
- Dose / conc.:
- 500 ppm (nominal)
- Remarks:
- low concentration
- Dose / conc.:
- 1 500 ppm (nominal)
- Remarks:
- mid concentration
- Dose / conc.:
- 3 000 ppm (nominal)
- Remarks:
- high concentration
- No. of animals per sex per dose:
- Total number of animals: 40
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data - Postmortem examinations (parental animals):
- At necropsy, right testes (n= 40) were prepared for histological examination and left testes and left epididymis (n= 40) from the same animal were frozen and processed for determination of sperm concentrations.
- Statistics:
- not specified
- Reproductive indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- male reproductive toxicity
- Effect level:
- 3 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive function (sperm measures)
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of testicular toxicity in male rats exposed via inhalation to 0, 500, 1500, or 3000 ppm of n-butyl acetate (6 hrs/day) for at least 65 exposures over 14 weeks. Therefore, the NOAEL for male reproductive toxicity following repeated inhalation exposure was determined to be 3000 ppm.
- Executive summary:
In a repeated dose toxicity study, male rats were exposed via inhalation to 0, 500, 1500, or 3,000 ppm (6 hrs/day) for at least 65 exposures over 14 weeks. At necropsy, right testes (n=40) were prepared for histological examination and left testes and left epididymis (n=40) from the same animal were frozen and processed for determination of sperm concentrations.
Overall weight gains for 3000 ppm exposure groups were 64% and 59% of controls for males and females, respectively. Overall weight gains for 1500 ppm exposure groups were 82% and 74% of controls for males and females, respectively. No significant differences in weight gain at 500 ppm vs. control.
Furthermore, there was no evidence of male reproductive toxicity at any exposure concentration based on lack of significant differences between treatments and controls for testicular spermatid head counts and epididymal spermatozoa counts as endpoints of toxicity. Therefore, a NOAEL for male reproductive toxicity following repeated exposure was 3000 ppm.
It should also be mentioned that the rapid in vivo hydrolysis of n-butyl acetate to 1-butanol makes this study directly applicable to 1-butanol exposures.
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