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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 201-159-0 | CAS number: 78-93-3
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- secondary source
- Title:
- No information
- Bibliographic source:
- ECHA database; http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d91195a-65f3-618d-e044-00144f67d249/DISS-9d91195a-65f3-618d-e044-00144f67d249_DISS-9d91195a-65f3-618d-e044-00144f67d249.html
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Deviations:
- yes
- Remarks:
- F2 pups were not necropsied
- Principles of method if other than guideline:
- The P animals were re-mated and F1b fetuses were produced and examined in a teratology study.
F1a pups were reared and mated and then necropsied as adults.
F1b fetuses were necropsied for a complete teratological examination. - GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Material was stated to be secondary butanol
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: drinking water
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
controls
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
3000 mg/l
Basis:
nominal in water
538 - 594 mg/kg/day
- Remarks:
- Doses / Concentrations:
10000 mg/l
Basis:
nominal in water
1644 - 1771 mg/kg/day
- Remarks:
- Doses / Concentrations:
20000 mg/l (F1 and F2 generations only)
Basis:
nominal in water
approx. 3000 mg/kg/day
- Remarks:
- Doses / Concentrations:
30000 mg/l (P generation only )
Basis:
nominal in water
5089 - 4571 mg/kg/day
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
Fertility rate for the P animals treated with 30000 mg/l was 73% (below historical norms for the rat colony).
In the 20000 mg/l dose group no effect on fertility was observed in the F1 matings.
Males had slightly elevated liver and kidney weights, and females had elevated liver weights at 20000 mg/l (not statistically significant).
Compared to water, 20000 mg/l evoked changes in kidneys of rats (males more than females) including an accelerated
appearance of tubular casts and focal tubular regeneration, development of microcysts in the apices of renal papillae, and
possibly epithelial degeneration in tubules in the outer medullary zone (results of examinations mature F1).
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: 1644 and 1771 mg/kg/day for males and females, respectively. Increased kidney weight and incidence of renal histopathological lesions at higher dose
Results: F1 generation
Details on results (F1)
No skeletal or soft tissue abnormalities or terata were observed with treatment.
Reduced birthweight was seen in the F2 pups exposed to 20000 mg/l.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 10 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: 1644 and 1771 mg/kg/day for males and females, respectively. Decreased offspring weights ath higher dose.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
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.
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.