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EC number: 204-658-1 | CAS number: 123-86-4
- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 15 DEC 1994 to 01 AUG 1995 (Analysis Dates)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well conducted and reported GLP study, but no histologic evaluation for testicular staging and spermatogenic index was performed
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Principles of method if other than guideline:
- Analysis of the number and concentration of testicular spermatids and epididymal spermatozoa in male rats exposed for 13-weeks by inhalation
- GLP compliance:
- yes
- Type of method:
- in vivo
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
- Details on test material:
- - Name of test material (as cited in study report): n-butyl acetate
- Physical state: clear liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
- Duration of test:
- 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 1500, 3000
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 males per dose
- Control animals:
- yes, sham-exposed
- Details on study design:
- - tissues were removed at necropsy (12/14/94) at Eastman Kodak Company and shipped to RTI overnight
- right testes from 40 animals were embedded in plastic, then cut, and slides prepared and stained for histological evaluations (fixation at necropsy: Millonig's fixative = NBF formalin diluted with phosphate buffered sline at pH 7.4; embedded in glycol methacrylat, one slight per testes stained with hematoxylin and eosin and the other with hematoxylin and periodic acid Schiff's reagent)
- left testes and left epididymidies from the same animals were frozen and processed to determine sperm concentrations (counting of homogenization resistant spermatids or sperms) - Statistics:
- - Bartlett's test for homogeneity of variances and normality of distribution
- anayllis of variance for overall significance
- Dunnett's test for comparisons of dosed groups to the controls
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 3 000 ppm
- Sex:
- male
- Basis for effect level:
- other: no effects on epididymial spermatozoa counts or testicular spermatid counts; the analytical exposure concentration for the 3000 ppm group was 3010 ppm (14.5 mg/L)
Observed effects
- there was no statistical difference between epididymal weights and epididymal spermatozoa count between control and treatment groups; one, four, five, and four animals from the dose groups 0, 500, 1500 and 3000 ppm, respectively, had low counts (= 12 x 10E6 spermatozoa per epididymis; the high-dose group's counts were decreased on average by 45% from controls (not statistically significant); the authors suggested that the variation in counts could be due to experimental error or that some animals may have ejaculated before or during necropsy
Any other information on results incl. tables
Effects of n-Butyl Acetate on Sperm Parameters in Sprague Dawley Rats
|
|
n-Butyl Acetate (ppm) |
|
|
0 |
500 1500 |
3000 |
||
Testis: |
|
|
|
|
Testicular Weight (g) |
1.78 ± 0.04 |
1.73 ± 0.07 |
1.79 ± 0.06 |
1.74 ± 0.04 |
Testicular Spermatict: |
|
|
|
|
Total Count (x 106) |
105.00 ± 14.27 |
107.30 ± 14.24 |
116.10 ± 8.61 |
89.80 ± 10.21 |
Count per mg (x 103) |
58.74 ± 7.46 |
61.93 ± 7.50 |
65.26 ± 5.13 |
51.54 ± 5.55 |
Epididymis: |
|
|
|
|
Epididymidal Weight (mg) |
823.42 ± 36.16 |
788.23 ± 16.86 |
764.73 ± 21.51 |
736.27 ± 25.81 |
Epididymidal Spermatozoa: |
|
|
|
|
Total Count (x 106) |
33.36 ± 5.09 |
23.04 ± 6.12 |
25.20 ± 10.33 |
18.48 ± 4.91 |
Count per mg (x 103) |
41.48 ± 6.67 |
29.12 ± 7.61 |
33.15 ± 13.71 |
24.14 ± 6.15 |
Values are means ± standard error of the means; n=10. Testes weights are from fresh tissue taken at necropsy. Epididymides weights are from frozen tissue taken at the time the spermatozoan counts were done.
ANOVA detected no significant differences among dose groups.
Applicant's summary and conclusion
- Conclusions:
- Inhalation exposure of n-butyl acetate at levels up to 3000 ppm (14.5 mg/L) for 13 weeks had no effect on the number of maturing spermatids or spermatozoa in male Sprague Dawley rats when epxosure began on at least eight weeks of age.
- Executive summary:
Male and female Sprague-Dawley rats were exposed to nominal concentrations of 0, 500, 1500 or 3000 ppm of n-butyl acetate for 6 hours per day, 5 days per week for 13 consecutive weeks. The time-weighted average analytical concentrations were within 10% of the target concentrations. At the end of the exposure period the animals were necropsied and testes and epididymis of the male animals (10 males per dose group) were collected and processed for the assessment of sperm count. n-Butyl acetate exposure had no effect on epididymidal spermatozoa counts or testicular spermatid counts. Testicular staging and determination of spermatogenic index was not performed. The NOAEC for andrological effects in this study was 3000 ppm (14.5 mg/L) (Francis and Fail, 1995; Bernard and David, 1996; David et al., 2001).
The study is reliable with restrictions (RL2).
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