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EC number: 445-630-0 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented guideline study conducted under GLP-conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-Butene-1,2-diol, diacetate
- IUPAC Name:
- 3-Butene-1,2-diol, diacetate
- Reference substance name:
- 1,2-diacetoxybut-3-ene
- EC Number:
- 421-720-5
- EC Name:
- 1,2-diacetoxybut-3-ene
- Cas Number:
- 18085-02-4
- Molecular formula:
- C8 H12 O4
- IUPAC Name:
- 1,2-diacetoxybut-3-ene
- Reference substance name:
- DIACETOXYBUTENE
- IUPAC Name:
- DIACETOXYBUTENE
- Details on test material:
- - Name of test material (as cited in study report): 3,4-DIACETOXY-1-BUTENE
- Physical state: Liquid, clear/colorless
- Other: Source: Eastman Kodak Chemical Company
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Crl:CD(SD)BR VAF plus; Charles River Kingston (Stone Ridge, NY)
- Age at study initiation: male rats were 6 weeks of age; female rats were 7 weeks of age
- Weight at study initiation: male rats weighed 129 to 157 grams; female rats weighed 135 to 162 grams
- Fasting period before study: overnight before single dose gavage
- Housing: rats were singly housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. Absorbent paper, used to collect excreta, was changed at least three times a week.
- Diet (e.g. ad libitum): Certified Rodent Diet (PMI® #5002, pelleted) was available ad libitum
- Water (e.g. ad libitum): Water was available ad libitum through an automatic watering system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 54-61
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours light from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test subst ance, a liquid, was administered as received
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on results of a range-finding test, doses of 500, 1000, and 2000 mg/kg of the test substance were selected as the dose levels for the oral toxicity study . - Doses:
- 500, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were collected on Days 0(prior to treatment), 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed:
1. clinical signs: Animals were observed three times on the day of dosing (Day 0), and once each day thereafter for the duration of the experiment . Observations included, but were not limited to, examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine, respiratory system, circulatory system, autonomic nervous system, central nervous system, and behavior patterns.
2. other: necropsy: Any animal that died during the study was necropsied as soon as possible. All surviving animals were euthanatized and necropsied at the completion of the 14-day observation period . - Statistics:
- No dose/mortality curve was constructed since graphs become statistically useful only with the use of large numbers of animals and dose groups . No furhter data given.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 794 mg/kg bw
- 95% CL:
- 483 - 1 305
- Remarks on result:
- other: combined LD50
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 891 mg/kg bw
- 95% CL:
- 451 - 1 759
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 707 mg/kg bw
- 95% CL:
- 318 - 1 574
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 2 - Clinical signs:
- other: Signs of toxicity related to dose levels: Clinical signs observed during the 14-day observation period included slight to severe weakness, vasodilation, and reduced feces. Severe weakness was noted only in animals assigned to the 2000 mg/kg dose group,
- Gross pathology:
- Effects on organs:
The cause of death for the rats which died after treatment
with the test substance was not determined. The treatment-
related changes observed at necropsy for the 2000 mg/kg animals and for the 1000 mg/kg female rats, which died within 24 hours of dosing, consisted of minimal to moderate hemorrhage in the glandular gastric mucosa. No treatment- related changes were observed at necropsy for the remaining
1000 mg/kg animals for any 500 mg/kg animals.
Any other information on results incl. tables
The test substance was a gastric tract irritant as evidenced by hemorrhage in the glandular gastric mucosa of rats from the 1000 and 2000 mg/kg bw dose groups. The acute oral LD50 for this test substance was calculated to be 891 mg/kg bw for male rats and 707 for female rats. Based on the oral LD50 calculated by combining the male and female mortality data (794 mg/kg bw), the test substance was classified as slightly toxic in rats according to the criteria set forth by Hodge and Sterner (1949) and harmful if swallowed as defined in the 18th Adaptation on the EC Classification, Packaging, and Labeling of Dangerous Substances.
Table 1: Results from the acute oral study (body weights)
Dose mg/kg bw |
Day 0 |
Day 7 |
Day 14 |
Male rats |
|||
500 |
136 |
Died Day 1 |
/ |
500 |
137 |
222 |
284 |
500 |
138 |
Died Day 1 |
/ |
500 |
151 |
246 |
316 |
500 |
157 |
255 |
320 |
1000 |
145 |
Died Day 1 |
/ |
1000 |
129 |
Died Day 1 |
/ |
1000 |
146 |
236 |
306 |
1000 |
155 |
240 |
317 |
1000 |
146 |
207 |
297 |
2000 |
151 |
Died Day 1 |
/ |
2000 |
143 |
Died Day 1 |
/ |
2000 |
154 |
Died Day 1 |
/ |
2000 |
142 |
Died Day 1 |
/ |
2000 |
143 |
Died Day 1 |
/ |
Female rats |
|||
500 |
148 |
213 |
245 |
500 |
138 |
189 |
217 |
500 |
135 |
203 |
231 |
500 |
145 |
Died Day 1 |
/ |
500 |
147 |
Died Day 1 |
/ |
1000 |
148 |
Died Day 1 |
/ |
1000 |
157 |
Died Day 1 |
/ |
1000 |
161 |
205 |
245 |
1000 |
162 |
Died Day 1 |
/ |
1000 |
154 |
214 |
247 |
2000 |
146 |
Died Day 1 |
/ |
2000 |
142 |
Died Day 1 |
/ |
2000 |
147 |
Died Day 1 |
/ |
2000 |
144 |
Died Day 1 |
/ |
2000 |
144 |
Died Day 1 |
/ |
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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