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EC number: 204-634-0 | CAS number: 123-54-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conduction and documentation of study very acceptable.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- Timed-pregnant Fischer 344 rats were exposed to 2,4-pentanedione vapour by inhalation on gestational days (gd) 6 to 15 at exposure target concentrations of 0, 50, 200 and 400 ppm to evaluate the embryotoxic and fetotoxic (including teratogenic) potential of the test substance administered during organogenesis. The day a copulation plug was found was designated gestational day (gd) 0. Twentyfive plug-positive females were assigned to each experimental group. Clinical observations were recorded daily, and maternal body weights were taken on gd 0, 6, 9, 12, 15 and 18. At scheduled necropsy on gd 21 (CO2 asphyxiation), dams were evaluated for body weight, liver and thymus weights, gravid uterine weight, and status of implantation sites (i.e. resorptions, dead fetuses, live fetuses). Maternal brains were removed, fixed and examined histopathologically. Live fetuses were dissected from the uterus, counted, weighed and sexed and examined for external abnormalities. Approximately one-half of the live fetuses in each litter was examined for visceral abnormalities. These fetuses were then decapitated and their heads fixed in Bouins solution and examined for soft tissue craniofacial malformations. The remaining intact fetuses in each litter were eviscerated, fixed in alcohol, stained with alizarin red S, and examined for skeletal defects and deficits.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Details on test material:
- Purity: 99.2%
Lot No.: S-050082
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Harlan Fischer F-344/HarBR
- Age: 81 days
- Housing: single housing in stainless steel wire-mesh cages
- Diet: Certified Rodent Chow, Ralston Purina Co., St. Louis, MO, ad libitum, except during vapour exposures
- Water: ad libitum, except during vapour exposures
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Photoperiod 12 hrs dark / 12 hrs light
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Atmospheres were generated by metering liquid 2,4-pentanedione into a heated glass evaporator, maintained at the lowest temperature sufficient to vaporize the liquid (range 44-56°C). The resultant vapour was diluted and carried into the exposure chamber by a countercurrent flow of conditioned air through the evaporator. Different concentrations were produced by varying the rate of metering of 2,4-pentanedione into the evaporator. Each chamber volume was 4320 litres.
- Temperature, humidity, pressure in air chamber: Chamber temperature, relative humidity, and airflow rate were recorded at least 4 times in each 6 hr period.
- Air flow rate: 1000 litres/min
- Air change rate: 14 air changes/hr
- Chamber volume: 4320 L
TEST ATMOSPHERE
- Brief description of analytical method used:
Each chamber atmosphere was analyzed for 2,4-pentanedione concentration every hour during each 6 hr exposure period, and daily nominal concentrations were also calculated for each chamber from a knowledge of amount of 2,4-pentanedione liquid used and the airflow rate. Test substance concentrations were measured using a Perkin-Elmer Model 3920B gas chromatograph equipped with a flame ionization detector. The column was a 10-foot x 1/8 inch stainless steel column packed with 10% SP2100 on 80/100 mesh Supelcoport (Supelco Inc., Bellefonte, Pennsylvania). Calibration of the gas chromatograph was carried out with dynamically generated gas standards of 2,4-pentanedione prepared by syringe injection of the test material into Tedlar gas bags. Gas standards of different concentrations were prepared to encompass the entire range generated in the exposure chambers.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- No decompositional changes or chamber loss of metered 2,4-pentanedione. The mean detected chamber concentrations of 2,4-pentanedione were 52 .7, 202 and 398 ppm for target concentrations of 50, 200 and 400 ppm.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Proof of pregnancy: [vaginal plug] referred to as [day 0] of pregnancy - Duration of treatment / exposure:
- Gestational day 6-15
- Frequency of treatment:
- 6 h/day
- Duration of test:
- Until gestational day 21
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
50, 200, 400 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
208, 831, 1661 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25 plug-positive females
- Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- Clinical observations were recorded daily, and maternal body weights were taken on gestational day 0, 6, 9, 12, 15 and 18. At scheduled necropsy on gestational day 21 (CO2 asphyxiation), dams were evaluated for body weight, liver and thymus weights. Maternal brains were removed, fixed and examined histopathologically.
- Ovaries and uterine content:
- Gravid uterine weight and status of implantation sites (i.e. resorptions, dead fetuses, live fetuses).
- Fetal examinations:
- Live fetuses were dissected from the uterus, counted, weighed and sexed and examined for external abnormalities. Approximately one-half of the live fetuses in each litter was examined for visceral abnormalities. These fetuses were then decapitated and their heads fixed in Bouins solution and examined for soft tissue craniofacial malformations. The remaining intact fetuses in each litter were eviscerated, fixed in alcohol, stained with alizarin red S, and examined for skeletal defects and deficits.
- Statistics:
- The unit for comparison was the pregnant female or the litter. Results of quantitative analytical variables (eg. maternal body weights, organ weights, foetal body weights) were intercompared for the 2,4-pentanedione-exposed groups and air-alone group by the use of the Levene test for equal variances, analysis of variance (ANOVA), and t-tests with Bonferroni probabilities. When Levene's test indicated homogeneous variances and the ANOVA was significant, the pooled t-test was used. When Levene's test indicated heterogeneous variances, all groups were compared by an ANOVA for unequal variances followed, when necessary, by the separate variance t-test. Students t-test was employed for analysis of incidence data, with the number of litters (with one or more affected foetuses) being the unit of comparison. Nonparametric data obtained following laparohysterectomy were treated statistically using the Kruskal-Wallis test, followed by the Mann-Whitney U test when appropriate. For all statistical tests, a fiducial limit of 0.05 (two-tailed) was used as the criterion for significance.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There was no maternal mortality in this study. Maternal toxicity was indicated by reduced body weights on gestational day (gd) 9, 12, 15, and 18 but not on gd 21, and reduced weight gain for the intervals gd 6-9, 6-12, 6-15 (exposure period) and gd 6-18, but not for the post-exposure period (gd 15-21). There were no treatment-related effects on maternal liver, thymus or gravid uterine weight, or on body weight (absolute or corrected for gravid uterus) at sacrifice; histologic examination of the maternal brains showed no pathological effects related to treatment. There were also no effects of treatment on the number of ovarian corpora lutea, of total, non-viable or viable implantations per litter, or on pre- or post-implantation loss or on sex ratio. There were no maternal deaths, early deliveries or abortions. Pregnancy rate was high and equivalent across all treatment groups. One dam each at 0, 50 and 200 ppm carried a totally resorbed litter on gd 21. Two dams at 400 ppm had totally resorbed litters on gd 21. Clinical observations were made daily throughout the study. Most of the observations were limited to the eyes, nose and blood at the vaginal orifice and only in a few dams per group. In addition, urogenital area wetness was present in a few dams only at 0, 50, 200 ppm (not at 400 ppm). At sacrifice on gd 21, there was no effect of exposure on maternal body weight, maternal body weight corrected for gravid uterine weight or on absolute or relative (to corrected body weight) thymus weight. Absolute and relative liver weight was elevated at 200 but not at 400 ppm. Administration of test substance vapour by inhalation to timed pregnant Fischer F-344 rats during organogenesis at 0, 50, 200 and 400 ppm resulted in matemal toxicity at 400 ppm.
Based on a significantly reduced body weight gain in the 400 ppm exposure group the NOAEL/LOAEL derived for maternal toxicity is 200 and 400 ppm, respectively.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 831 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 1 661 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Significant reduction in female body weight per litter at 400 ppm (all fetuses, males and females approximately 10 %) and at 200 ppm (all fetuses, and males but not females approximately 3%). One visceral variation (partial fetal atelectasis) significantly increased at 400 ppm. 17 out of 79 observed skeletal variations exhibited significant changes in incidence and indicated a consistent pattern of reduced ossification in the 400 ppm group (for example poorly or unossified phalanges, unossified cervical or poorly ossified thoracic centrum). No differences among the groups in the incidence of external, visceral or skeletal malformations. No further treatment related effects. The NOAEL/LOAEL for developmental toxicity is 50 and 200 ppm, respectively, which is based on reduced fetal weights in male fetuses at 200 ppm and in male and female fetuses at 400 ppm and a consistent pattern of reduced fetal ossification at 400 ppm.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 661 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- 208 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 831 mg/m³ air
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Body Weight of Foetuses Removed on Gestational Day 21 from 2,4-pentanedione - Vapour-exposed and Air-alone Control Fischer 344 Rats.
Foetal weight per litter (g) (Means± SD) |
2,4-pentanedione analytical concentration (ppm) |
|||
|
0 |
53 |
202 |
398 |
Number of litters |
22 |
20 |
23 |
20 |
All foetuses |
4.57 ± 0.20 |
4.55 ± 0.23 |
4.42 ± 0.14 e |
4 .10 ± 0.14 f |
Male fetuses |
4.71 ± 0.18 b |
4.68 ± 0.24 c |
4.57 ± 0.19 e |
4.24 ± 0.14 d,f |
Female fetuses |
4.40 ± 0.19 b |
19b 4.41 ± 0.21 |
4.28 ± 0.17 |
3 .95 ± 0.14 d,f |
b: N = 21 because one litter contained only female foetuses and one litter contained only male foetuses at 0
ppm
c: N = 19 because one litter contained only female foetuses at 53 ppm
d: N = 19 because one litter contained only female foetuses and one litter contained only male foetuses at 398 ppm
e: p < 0.05 (compared to controls)
f: p < 0.001 (compared to controls)
Table 2: Significant Variations Observed in Foetuses and Litters: Dams Exposed to 2,4-Pentanedione Vapour on Gestational Days 6 through 15a.
|
Foetuses |
Litters |
||||||
Group (ppm) |
0 |
53 |
202 |
398 |
0 |
53 |
202 |
398 |
Number examined externally, b |
|
|
|
|
|
|
|
|
No significant findings |
183 |
162 |
195 |
167 |
22 |
20 |
23 |
20 |
Number examined Viscerally, c |
96 |
87 |
104 |
90 |
22 |
20 |
23 |
20 |
Partial Foetal Atelectasis |
8 |
15 |
21 |
14 |
5 |
10 |
9 |
12, f |
8.3 |
17.2 |
20.2 |
15.6 |
22.7 |
50.0 |
39.1 |
60.0 |
|
Number examined Skeletallv, d |
87 |
75 |
91 |
77 |
22 |
20 |
23 |
19, e |
Cervical centrum #6 unossified |
2 |
2 |
2 |
10 |
2 |
1 |
2 |
9, f |
2.3 |
2.7 |
2.2 |
13.0 |
9.1 |
5.0 |
8.7 |
47.4 |
|
Cervical centrum #6 bilobed |
18 |
13 |
7 |
1 |
14 |
9 |
6, f |
1, g |
20.7 |
17.3 |
17.7 |
1.3 |
63.6 |
45.0 |
26.1 |
5.3 |
|
Cervical centrum #5 unossified |
6 |
5 |
10 |
34 |
6 |
4 |
10 |
16, g |
6.9 |
6.7 |
11.0 |
44.2 |
27.3 |
20.0 |
43.5 |
84.2 |
|
Cervical centrum #5 bilobed |
9 |
6 |
4 |
1 |
8 |
6 |
4 |
1, f |
10.3 |
8.0 |
4.4 |
1.3 |
36.4 |
30.0 |
17.4 |
26.3 |
|
Thoracic centrum # 1 poorly ossified |
0 |
0 |
4 |
7 |
0 |
0 |
4 |
5, f |
0.0 |
0.0 |
4.4 |
9.1 |
0.0 |
0.0 |
17.4 |
5.3 |
|
Premaxillary poorly ossified |
2 |
0 |
2 |
10 |
2 |
0 |
2 |
8, f |
2.3 |
0.0 |
2.2 |
13.0 |
9.1 |
0.0 |
8.7 |
42.1 |
|
Some proximal Phalages (forelimb) poorly ossified
|
41 |
46 |
67 |
72 |
16 |
15 |
21 |
19, f |
47.1 |
61.3 |
73.6 |
93.5 |
72.7 |
75.0 |
91.3 |
100.0 |
|
Majoriry proximal phalages (hindlimb) poorly ossified |
46 |
41 |
52 |
13 |
19 |
17 |
19 |
8, g |
52.9 |
54.7 |
57.1 |
16.9 |
88.4 |
85.0 |
82.6 |
42.1 |
|
Some proximal phalanges (hindlimb unossified) |
58 |
55 |
68 |
16 |
20 |
18 |
21 |
10, f |
66.7 |
73.3 |
74.7 |
20.8 |
90.9 |
90.0 |
91.3 |
52.6 |
|
Majority proximal phalanges (hindlimb) unossified |
8 |
11 |
9 |
19 |
5 |
8 |
8 |
11, f |
9.2 |
14.7 |
9.9 |
24.7 |
22.7 |
40.0 |
34.8 |
42.9 |
|
All proximal phalanges (hindlimb) Unossified |
9 |
4 |
11 |
42 |
8 |
4 |
9 |
16, g |
10.3 |
5.3 |
12.1 |
54.5 |
36.4 |
20.0 |
39.1 |
84.2 |
|
Some metatarsals (hindlimb) poorly ossified |
6 |
1 |
7 |
33 |
5 |
1 |
7 |
15, g |
6.9 |
1.3 |
7.7 |
42.9 |
22.7 |
5.0 |
30.4 |
78.9 |
|
Yiphoid process (sternebra #6) poorly ossified
|
7 |
3 |
7 |
30 |
5 |
3 |
7 |
15,g |
8.0 |
4.0 |
7.7 |
39.0 |
22.7 |
15.0 |
30.4 |
78.9 |
|
Number with external variations |
14 |
16 |
20 |
13 |
10 |
10 |
11 |
9 |
Percent with external variations
|
7.7 |
9.9 |
10.3 |
7.8 |
45.5 |
50.0 |
47.8 |
45.0 |
Number with soft tissue variations
|
64 |
70 |
94 |
75 |
20 |
20 |
23 |
19 |
Percent with soft tissue variations
|
66.7 |
80.5 |
90.4 |
83.3 |
90.9 |
100.0 |
100.0 |
95.0 |
Number with skeletal variation s |
87 |
75 |
91 |
77 |
22 |
20 |
23 |
19 |
Percent with skeletal variations
|
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
100.0 |
Total number with variations |
152 |
146 |
186 |
153 |
22 |
20 |
23 |
19 |
Total percent with variations |
83.1 |
90.1 |
95.4 |
91.6 |
100.0 |
100.0 |
100.0 |
95.0 |
aFor all fïndings, the number (of foetuses affected or litters with one or more affected foetuses) is presented on top and the percentage of the total (foetuses of litters) examined is presented beneath. A single foetus may be represented more than once in listing individual defects. Only live foetuses were examined.
bAll Foetuses were examined externally.
cApproximately 50% of each litter were examined viscerally and for soft tissue craniofacial defects.
dApproximately 50% of each litter were examined for skeletal defects after staining with alizarin red S.
eOne litter consisted of only one live foetus. By convention in this laboratory, this foetus was examined for visceral and craniofacial alterations.
fp < 0.05
gp < 0.01
Applicant's summary and conclusion
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