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EC number: 948-047-4 | 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
Endpoint summary
Administrative data
Description of key information
In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 5000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is >5000 mg/kg bw.
In a reliable acute toxicity study a structurally similar substance was administered to Wistar rats (5 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The oral LD50 is greater than 2000 mg/kg bw.
In a reliable acute dermal toxicity study a structurally similar substance was administered to Wistar rats (5 animals/sex/dose) by semi occlusive dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The dermal LD50 is greater than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Read-across to a K1 study therefore K2 is the maximum Klimisch score that can be assigned.
- Justification for type of information:
- A read-across justification is provided in section 13 of the IUCLID file.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany.
- Fasting period before study: 16 h
- Housing: 5 animals of the same sex per cage in Makrolon 3 cages.
- Litter: soft wood granulate.
- Diet: Altromin-Haltungsdiät 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 8 days
- Identification of the test animals: Group identification by cage labelling, individual identification by labelling with saturated picric acid solution.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At day of application, animals were observed several times, thereafter 2 times per day until Day 14. Weighing was performed one day before application, directly before application, 48 h after application and at Day 7 and Day 14 after application.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross necropsy and body weight. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed at the end of the 14-day observation period.
- Gross pathology:
- Males: tightly filled urinary bladder in 1/5 males 14 days after application. 4/5 males showed no clinical signs of toxicity at the end of the 14-day observation period.
Females: 4/5 females showed no clinical signs of toxicity. In 1/5 females a mild hydrometra was observed. According to the author the hydrometra was not due to the substance treatment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is greater than 2000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Wistar rats (5 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is greater than 2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Read-across to K2 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- White flaky solid.
Lot #12735 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight of animals 184 - 205g.
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2.5%
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None.
- Clinical signs:
- other: None.
- Gross pathology:
- There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
- Other findings:
- All animals appeared active and healthy.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 is >5000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 5000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The LD50 is >5000 mg/kg bw.
Referenceopen allclose all
Table 1. Mean body weights in g.
Doses |
2000 mg/kg bw |
2000 mg/kg bw |
- 1 d |
185 |
168 |
0 d |
173 |
159 |
2 d |
194 |
172 |
7 d |
213 |
172 |
14 d |
239 |
182 |
body weight gain |
54 |
14 |
d = day of study
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across to K1 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Test type:
- standard acute method
- Specific details on test material used for the study:
- Batch number: 12430
General characteristics: Odourless oily liquid
Purity: Butanediol dioctanoate: 36.3 (% by area); Butanediol octanoate decanoate: 46.3 (% by area); Butanediol didecanoate: 15.1 (% by area)
Storage conditions: In a closed container in a laboratory hood
Stable until: 06/1993 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight of animals at start of test: 200-300 g
Room temperature: 20±3°C
Rel humidity: 30-70%
Acclimitisation: At least 5 days - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The volume administered was 2.2 cm3/kg bw
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not specified
- Details on study design:
- The animals were examined for clinical signs 1/2, 1, 2, 3, 4, 5 and 6 hours after administration and once a day for the next two weeks. The relevant area was examined for dermal reactions related to the test substance. The time of occurrence and the nature of the signs were recorded separately for each animal. The animals were weighed on the day of administration (day 0), on day 7 and at the end of the test (day 14). After the observation period of 14 days, all the animals were sacrificed by inhalation of carbon dioxide, necropsied and inspected for macroscopic changes to organs. The necropsy results were recorded separately for each animal.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities during the study.
- Clinical signs:
- other: No signs of toxicity related to the substance were found with the dose of 2000 mg/kg bodyweight during the 14-day observation period.
- Gross pathology:
- The necropsies at the end of the study revealed no macroscopic changes to organs, nor were there any abnormalities in the skin and subcutaneous tissue in the application area.
- Other findings:
- The animals showed no dermal reactions 24 hours after administration and up to the end of the observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 is greater than 2000 mg/kg bw.
- Executive summary:
In an acute toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by semi occlusive dermal application at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination. The dermal LD50 is greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Sufficient to address requirements.
Additional information
Justification for classification or non-classification
Based on the findings of a reliable acute oral toxicity study conducted on a structurally similar substance, classification of the substance is not justified.
Based on the findings of a reliable dermal toxicity study conducted on a structurally similar substance, classification of the substance is not justified.
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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