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EC number: 207-997-3 | CAS number: 504-63-2
- 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:
- multi-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- information beyond standard information requirements
- Justification for type of information:
- Additional documentation, provided within the IUCLID Assessment Reports (Section 13), supports the read-across approach.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- estrous cycle, sperm evaluation, vaginal opening and preputial separation exams not conducted; study was conducted for 5 generations
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Test compound was obtained from the Celanese Chemical Company, New York.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not reported
- Route of administration:
- oral: feed
- Details on exposure:
- A semipurified diet with the following basal composition was used:
20% Caesin
8% Refined corn oil
4% Salt mix
1% Vitamin mix
33.5% Corn starch
33.5% Dextrose
The test diets were prepared by substituting the test material for equal amounts by weight of corn starch and dextrose. - Details on mating procedure:
- F0 geneartion rats were paired after 4 weeks of treatment. At 1-2 weeks after weaning of the first litters, each female of the F0 generation was mated with a different male, and a second series of litters was produced. Insemination was confirmed by observation of a vaginal sperm plug; this observation date was designated as day 0 of pregnancy. If semination had not been confirmed by the seventh day, the female was paired to another male of the same group for an additional 7 days. Females which did not become pregnant within this time period were considered infertile and were discarded. The initial litters were reared to maturity as the F1A generation which was assigned to the longevity phase of the study and subjected to repeated reproduction cycles. All animals of the second series of litters (the F1B generation) were discarded at weaning except for 10 males per group which were reared and used in a dominant lethal test.
After 11 weeks of feeding, the F1A rats were paired to produce the F2 generation. In all, five succesive mating cycles were achieved iwth the F1A rats within a period of 77 weeks. Pups weaned fropm the first litters of the F1A females became the F2A parent, which were used to produce the F3 generation. Each set of F2A parents was mated twice to yield two litters of offspring. The F3A females were permitted to mature to term and cast litters of F4A and F4B generations. The procedure for confirmation of insemination were identical to those described for F0 females. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks treatment prior to F0 generation being paired. Females of the F0 generation were fed their respective diets throughout mating, gestation, and lactation phase of the study. After 11 weeks of feeding, the F1A rats were paired to produce the F2 generation. In all, five successive mating cycles were achieved.
- Frequency of treatment:
- daily
- Dose / conc.:
- 5 other: % (nominal in diet)
- Dose / conc.:
- 10 other: % (nominal in diet)
- Dose / conc.:
- 24 other: % (nominal in diet)
- No. of animals per sex per dose:
- 25 per sex per group
- Control animals:
- yes
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: not reported
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Time schedule: not reported
OTHER:
Blood samples were collected from 10 rats/sex/group for determination of alkaline phosphotase, glucose, hematocrit, hemoglobin, and total and differential leucocyte counts. Urine analysis of the same animals provided measurements of albumin, glucose, ketones, occult blood, pH, specific gravity, and miscroscopic examination of the sediment. The samples were collected from the F0 rats after 4 weeks on their respective diets. Samples were collected from the F1 rats after 11 weeks of feeding. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined:
number of pregnant females, number of pups cast alive or dead, pup weights and survival of progeny - Postmortem examinations (parental animals):
- For the F1A rats, the gonads and pituitary glands were examined microscopically.
- Reproductive indices:
- Fertility: % matings resulting in pregnancies
Gestation: % pregnancies resulting in litters cast alive
Viability: % pups cast alive that survived to 4 days
Lacatation: % pups alive at 4 days that survived to 21 days - Remarks on result:
- other: See "Remarks"
- Remarks:
- For four of five generations of rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed. However, an apparent dose-related effect decrease in fertility occurred during five successive mating cycles of F1A rats.
- Critical effects observed:
- no
- Remarks on result:
- other: In rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed. However, an apparent dose-related effect decrease in fertility occurred during five successive mating cycles of F1A rats.
- Remarks on result:
- other: In rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed.
- Reproductive effects observed:
- no
- Conclusions:
- For four of five generations of rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed. However, an apparent dose-related effect decrease in fertility occurred during five successive mating cycles of F1A rats.
- Executive summary:
The effect of 1,3-butanediol on reproductive performance were studied in five generations of Wistar rats. Animals of both sexes were fed either control diet or diet supplemented with 1,3-butanediol at dose levels of 5, 10, or 24% of the diet by weight. Reproduction and lactation parameters were comparative to controls for four or five generations of dams and pups. In contrast, the pregnancy rate of F1A rats decreased during five successive mating cycles; no pups were obtained in the high dose-group of the fifth series of litters (F2E generation). Excluding this group, the viability of F2 generation pups revealed no significant differences between litters or between control and test groups.
Body weights: For four consecutive generations, female animals showed no significantly abnormal growth rates, but body weight gains of male rats in all four generations were slightly depressed, with an apparent dose relationship. However, efficiency of food utilization through 10 weeks of post-weaning remained constant for all generations of both sexes and was not affected by the level of 1,3-butanediol in the diet.
Clinical studies: Hematology, blood chemistry and urinalysis studies showed no trends associated with treatment of F0, F1, F2, and F3 generation animals.
During five successive mating cycles of F1A rats, a gradual decrease in the pregnancy rate was seen. Both the number of pregnant females and the fertility index appeared to be dose-related for several series of F2 litters, especially F2D and F2E. For the fifth series of litters, no pups were obtained in the high dose group. However, the gestation, viability, and lactation indexes, as well as the mean pup body weights at 4 and 21 days showed no significant differences between specific litter series or between control and test groups (excluding high-dose animals of the fifth series of litters). No significant treatment-related differences were noted on histopathologic examination of testes or ovaries and pituitary glands as a possible explanation of the observed reproductive failure during the fifth cycle.
For the other three generations of dams and pups, no significant dose-related trends were observed for the reproduction and lactation parameters.
|
|
|
Average no. of pups per litter |
Indexes |
||||
Generation/ Dietray Level (%) |
No of matings |
No of pregnant females |
Cast alive |
Cast dead |
Fertility |
Gestation |
Viability |
Lactation |
F2A |
|
|||||||
0 |
25 |
18 |
9.3 |
1.4 |
72 |
94 |
84 |
83 |
5 |
25 |
20 |
9.9 |
0.5 |
80 |
100 |
85 |
90 |
10 |
25 |
23 |
9.7 |
0.2 |
92 |
100 |
75 |
90 |
24 |
25 |
19 |
8.4 |
0.8 |
76 |
100 |
93 |
99 |
F2B |
|
|||||||
0 |
25 |
11 |
10.1 |
0.5 |
44 |
100 |
76 |
90 |
5 |
25 |
11 |
9.7 |
0.1 |
44 |
100 |
98 |
90 |
10 |
25 |
16 |
10.2 |
0.3 |
64 |
100 |
98 |
100 |
24 |
25 |
13 |
10.2 |
0.4 |
52 |
100 |
88 |
99 |
F2C |
||||||||
0 |
25 |
16 |
8.1 |
0.8 |
64 |
94 |
88 |
75 |
5 |
25 |
19 |
9.8 |
0.2 |
76 |
100 |
96 |
99 |
10 |
25 |
17 |
10.0 |
0.0 |
68 |
94 |
97 |
94 |
14 |
25 |
11 |
8.1 |
0.1 |
44 |
100 |
97 |
79 |
F2D |
||||||||
0 |
25 |
15 |
9.1 |
0.1 |
60 |
100 |
81 |
95 |
5 |
25 |
15 |
9.6 |
0.1 |
60 |
100 |
99 |
100 |
10 |
25 |
10 |
9.8 |
0.1 |
40 |
100 |
99 |
100 |
14 |
25 |
7 |
7.7 |
0.4 |
28 |
100 |
87 |
100 |
F2E |
||||||||
0 |
25 |
10 |
5.4 |
0.8 |
40 |
90 |
85 |
98 |
5 |
25 |
4 |
7.0 |
0.5 |
16 |
100 |
100 |
100 |
10 |
25 |
5 |
7.4 |
0.4 |
20 |
100 |
84 |
100 |
14 |
25 |
0 |
0 |
0 |
0 |
- |
- |
- |
|
|
|
Average no. of pups per litter |
Indexes |
||||
Generation/ Dietray Level (%) |
No of matings |
No of pregnant females |
Cast alive |
Cast dead |
Fertility |
Gestation |
Viability |
Lactation |
F1A |
|
|||||||
0 |
25 |
23 |
10.0 |
0.6 |
92 |
100 |
98 |
98 |
5 |
25 |
21 |
10.4 |
0.3 |
84 |
100 |
91 |
99 |
10 |
25 |
19 |
10.3 |
0.3 |
76 |
100 |
96 |
96 |
24 |
25 |
20 |
9.3 |
0.3 |
80 |
100 |
84 |
96 |
F1B |
|
|||||||
0 |
25 |
20 |
8.8 |
0.5 |
80 |
100 |
94 |
95 |
5 |
25 |
17 |
8.8 |
0.8 |
68 |
100 |
85 |
95 |
10 |
25 |
13 |
9.6 |
0.5 |
52 |
100 |
95 |
96 |
24 |
25 |
16 |
8.1 |
0.3 |
64 |
100 |
88 |
91 |
|
|
|
Average no. of pups per litter |
Indexes |
||||
Generation/ Dietray Level (%) |
No of matings |
No of pregnant females |
Cast alive |
Cast dead |
Fertility |
Gestation |
Viability |
Lactation |
F3A |
|
|||||||
0 |
24 |
18 |
10.3 |
0.4 |
75 |
100 |
98 |
99 |
5 |
25 |
22 |
8.9 |
0.1 |
88 |
96 |
95 |
97 |
10 |
25 |
17 |
9.9 |
0.1 |
68 |
100 |
95 |
91 |
24 |
25 |
23 |
9.7 |
0 |
92 |
96 |
95 |
100 |
F3B |
|
|||||||
0 |
7 |
6 |
11.2 |
1.0 |
86 |
100 |
100 |
100 |
5 |
8 |
7 |
9.3 |
0.4 |
88 |
96 |
95 |
92 |
10 |
8 |
7 |
9.6 |
0 |
88 |
100 |
100 |
83 |
24 |
6 |
4 |
11.8 |
0.3 |
68 |
100 |
92 |
100 |
|
|
|
Average no. of pups per litter |
Indexes |
||||
Generation/ Dietray Level (%) |
No of matings |
No of pregnant females |
Cast alive |
Cast dead |
Fertility |
Gestation |
Viability |
Lactation |
F4A |
|
|||||||
0 |
25 |
22 |
10.9 |
0.7 |
88 |
100 |
98 |
97 |
5 |
25 |
18 |
9.8 |
0.1 |
72 |
100 |
81 |
97 |
10 |
25 |
20 |
10.5 |
0.1 |
80 |
100 |
94 |
97 |
24 |
25 |
22 |
9.7 |
0.6 |
88 |
96 |
88 |
99 |
F4B |
|
|||||||
0 |
25 |
22 |
11.3 |
0.4 |
88 |
100 |
97 |
99 |
5 |
25 |
21 |
9.7 |
0.3 |
84 |
100 |
99 |
89 |
10 |
25 |
21 |
10.1 |
0 |
84 |
100 |
99 |
90 |
24 |
25 |
20 |
9.2 |
0.2 |
80 |
100 |
96 |
96 |
Data source
Materials and methods
Test material
- Reference substance name:
- Butane-1,3-diol
- EC Number:
- 203-529-7
- EC Name:
- Butane-1,3-diol
- Cas Number:
- 107-88-0
- IUPAC Name:
- butane-1,3-diol
- Reference substance name:
- 1,3-Butanediol
- IUPAC Name:
- 1,3-Butanediol
- Details on test material:
- - Purity: Not reported
Constituent 1
Constituent 2
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Remarks on result:
- other: see 'Remark"
- Remarks:
- For four of five generations of rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed. However, an apparent dose-related effect decrease in fertility occurred during five successive mating cycles of F1A rats.
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: In rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed. However, an apparent dose-related effect decrease in fertility occurred during five successive mating cycles of F1A rats.
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- other: In rats treated at levels up to 24% of the diet, no adverse effects on reproduction and lactation parameters were observed.
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
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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