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Diss Factsheets
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EC number: 421-720-5 | CAS number: 18085-02-4 3,4-DIACETOXY-1-BUTENE
- 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
Endpoint summary
Administrative data
Description of key information
Data available includes an acute oral toxicity study provided by ECHA and an acute dermal toxicity study (conducted to OECD guidelines and GLP) as the relevant second exposure route.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data migrated from NONS with permission to refer granted by ECHA.
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 794 mg/kg bw
- Based on:
- not specified
- 95% CL:
- >= 483 - <= 1 305
- Mortality:
- 2000 mg/kg bw: 5/5
1000 mg/kg bw: 2/5 - Gross pathology:
- No treatment-related macroscopic effects observed
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- in accodance with CLP regulation (1272/2008/EC, as amended))
- Conclusions:
- Based on data provided by ECHA, the acute oral LD50 value is 794 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 794 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CD(SD)BR/VAF Plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kingston (Stone Ridge, NY)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Males 6 to 7 weeks and females 7 to 8 weeks
- Weight at study initiation: Males 162 to 191g and females 161 to 170g
- Fasting period before study: None
- Housing: Singly housed in suspended stainless steel wire mesh cages.
- Diet (e.g. ad libitum): Certified rodent diet freely available
- Water (e.g. ad libitum): Water available freely
- Acclimation period: 5 days ahead of study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 54 to 60%
- Air changes (per hr): Not detailed
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Not detailed (applied to dorsal surface)
- % coverage: Not detailed
- Type of wrap if used: Occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (running water)
- Time after start of exposure: After 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw applied directly
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight - Statistics:
- Not applicable to study design
- Preliminary study:
- Not conducted
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No toxicologically significant clinical signs were observed
- Gross pathology:
- No toxicologically significiant findings were noted at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A reliable guideline study indicates that the test material is unlikely to cause dermal toxicity or skin irritation after exposure to the substance, with an LD50 value > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
An acute toxicity study by the inhalation route is not required as the requirements for a second exposure route (in addition to the oral route) have been met by performance of an acute dermal toxicity study.
Justification for classification or non-classification
In the acute oral toxicity study provided by ECHA, the LD50 value of 794 mg/kg bw indicates that classification as Acute Toxicity Category 4 (harmful if swallowed) is appropriate (LD50 < 300 and </= 2000 mg/kg bw). This is in accordance with the CLP Regulation (EC No. 1272/2008, as amended). This classification already appears in Annex VI of CLP.
With regards to the acute dermal toxicity study, there were no toxic or irritant effects observed with the LD50 > 2000 mg/kg bw. Accordingly the substance would not be classified in accordance with the CLP regulation (EC No. 1272/2008, as amended).
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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