Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-686-6 | CAS number: 1185-57-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database.
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute Toxicity Study - Test chemical
- Author:
- National Toxicology Program
- Year:
- 1 999
- Bibliographic source:
- National Toxicology Program
- Reference Type:
- other: authoritative database
- Title:
- Acute Dermal toxicity - Test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: secondary source
- Title:
- Acute dermal toxicity (LD50) test in rabbits.
- Author:
- National Technical Reports Library
- Year:
- 1 980
- Bibliographic source:
- National Technical Reports Library
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity test was access in rabbits using the given test chemical.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Butane-1,2,3,4-tetracarboxylic acid
- EC Number:
- 216-938-0
- EC Name:
- Butane-1,2,3,4-tetracarboxylic acid
- Cas Number:
- 1703-58-8
- Molecular formula:
- C8H10O8
- IUPAC Name:
- Butane-1,2,3,4-tetracarboxylic acid
- Test material form:
- solid
- Details on test material:
- - Name of the test chemical: Butane-1,2,3,4-tetracarboxylic acid
- IUPAC name: Butane-1,2,3,4-tetracarboxylic acid
- Molecular Formula: C8H10O8
- Molecular Weight: 234.159 g/mol
- Smile Notation: OC(=O)C[C@H]([C@H](CC(=O)O)C(=O)O)C(=O)O
- InChI : 1S/C8H10O8/c9-5(10)1-3(7(13)14)4(8(15)16)2-6(11)12/h3-4H,1-2H2,(H,9,10)(H,11,12)(H,13,14)(H,15,16)/t3-,4+
- Substance type: organic
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.30 to 2.86 kg
- Fasting period before study: Not fasted
- Housing: The animals were individually housed in metal cages elevated above the droppings
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitium
- Water (e.g. ad libitum): Tap water, ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: 50%(w/w) isotonic saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: intact and abraded skin of the trunk, free of hair
- % coverage: two or three centimeters longitudinally over the area of exposure.
- Type of wrap if used: A plastic binder was slipped onto each animal, which was then placed in a comfortable but immobilized position in a multiple animal holder. The binder was then fastened tightly to keep the preparation in close contact with the skin for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the period of exposure, the binders were removed, the amount of unabsorbed material estimated, the skin reactions recorded, and the remaining test material wiped from the animals' bodies.
- Time after start of exposure:24 hours - Duration of exposure:
- Single exposure for a period of 24 hours
- Doses:
- 2000, 4000, 8000 mg/kg bw
- No. of animals per sex per dose:
- Twelve rabbits, 6 animals per sex
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes, animals which succumbed were necropsied.
- Other examinations performed: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days.Following the observation period, all surviving animals were weighed, sacrificed and necropsied. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 8 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality was observed.
- Mortality:
- No mortality at highest dose level.
- Clinical signs:
- other: Few systemic signs of toxicity were observed at any dose level. At all dose levels there was moderate to severe erythema with chemical burns and/or blanching especially along abrasions The intensity increased with the dose level.This was followed at 7 and
- Gross pathology:
- Gross necropsy of animal which succumbed showed the skin to have severe erythema of sides and ventrum with severe congestion appearance of subcutaneous tissue. It has the appearance of chemical burns. The stomach was blanched with severe erosion of the mucosal surface. The small intestines showed severe scattered congestion.
Gross necropsy of the animals sacrificed at 14 days showed one animal at 8000 mg./kg with an approximate 90% loss of fat tissue. Other organs and tissues in all animals were not remarkable. - Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The acute dermal toxicity dose (LD50) was considered to be >8000 mg/kg, when 12 New Zealand Albino rabbits, six males and six females, were treated with the given test chemical following dermal application by a single exposure for a period of 24 hours.
- Executive summary:
The acute dermal toxicity study was conducted by using the given test chemical in 12 New Zealand Albino rabbits, six males and six females, were used to evaluate the potential toxicity following dermal application by a single exposure for a period of 24 hours at the concentrations of 2000, 4000, 8000 mg/kg bw.
Prior to exposure, the animals were prepared by clipping the skin of the trunk free of hair, and only those animals without observable skin defects or irritation were used. One-half of the animals in each group were further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of exposure. Abrasions were sufficiently deep to penetrate the stratum corneum but not to disturb the derma. A plastic binder was slipped onto each animal, which was then placed in a comfortable but immobilized position in a multiple animal holder. Test chemical in the form of a 50% w/w suspension in isotonic saline, was introduced under the plastic binder; the binder was then fastened tightly to keep the preparation in close contact with the skin for 24 hours. At the end of the period of exposure, the binders were removed, the amount of unabsorbed material estimated, the skin reactions recorded, and the remaining test material wiped from the animals' bodies. The animals were housed in their respective cages. The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days. Animals which succumbed were necropsied. Following the observation period, all surviving animals were weighed, sacrificed and necropsied.
No mortality at highest dose level. Few systemic signs of toxicity were observed at any dose level. At all dose levels there was moderate to severe erythema with chemical burns and/or blanching especially along abrasions The intensity increased with the dose level.This was followed at 7 and 14 days with desquamation and drying. At 2000 mg/kg bw, two animals exhibited a generalized weakness for 24 to 48 hours after dosing. At 8000 mg/kg bw, one animal exhibited generalized weakness for 72 hours and three animals were observed to be thin after 72 hours and until day 10 of the study. Final body weight of surviving animals at termination showed two with intact skin and one with abraded skin at 2000 mg/kg bw to have significant (100% or greater) weight gains. At 4000 mg/kg bw, one (abraded skin) has a significant weight gain. Other surviving animals had weight gains or losses which were less than 10%. Gross necropsy of animal which succumbed showed the skin to have severe erythema of sides and ventrum with severe congestion appearance of subcutaneous tissue. It has the appearance of chemical burns. The stomach was blanched with severe erosion of the mucosal surface. The small intestines showed severe scattered congestion. Gross necropsy of the animals sacrificed at 14 days showed one animal at 8000 mg/kg with an approximate 90% loss of fat tissue. Other organs and tissues in all animals were not remarkable.
Under the condition of the study, the acute dermal toxicity dose (LD50) was considered to be >8000 mg/kg, when 12 New Zealand Albino rabbits, six males and six females, were treated with the given test chemical following dermal application by a single exposure for a period of 24 hours.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.