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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-256-0 | CAS number: 6990-06-3
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Study with eight male rabbits (New Zealand White). An area 6 cm x 10cm was shaved on the back of the rabbits. Four of the rabbits were treated with 1% sodium lauryl sulphate in vaseline. The remaining four rabbits were untreated. After 24 hours ca. 1g of salve was applied to the shaved area of all eight rabbits. Blood samples were taken after 0,2,4,6,8,24 and 48 hours after application.
- GLP compliance:
- no
Test material
- Reference substance name:
- Fusidic acid
- EC Number:
- 230-256-0
- EC Name:
- Fusidic acid
- Cas Number:
- 6990-06-3
- Molecular formula:
- C31H48O6
- IUPAC Name:
- 2-[(1Z,2S,3aS,3bS,5aS,6S,7R,9aS,9bS,10R,11aR)-2-(acetyloxy)-7,10-dihydroxy-3a,3b,6,9a-tetramethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-1-ylidene]-6-methylhept-5-enoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Details are given for each individual study
Constituent 1
- Specific details on test material used for the study:
- Salve containing 2% tritiated fucidin in fucidin salve (without lanolin) containing 0.68 mCi/g
- Radiolabelling:
- yes
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Body weight between 2.55 and 3.05 kg.
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 48 hours
- Doses:
- 1 g salve of 0.68 mCi/g
- No. of animals per group:
- 8
- Control animals:
- no
- Details on study design:
- An area 6 cm x 10cm was shaved on the back of the rabbits. Four of the rabbits were treated with 1% sodium lauryl sulphate in vaseline. The remaining four rabbits were untreated. After 24 hours ca. 1g of salve was applied to the shaved area of all 8 rabbits. Blood samples were taken after 0,2,4,6,8,24 and 48 hours after application. The animals were kept in stocks for the first 24 hours after application.
Serum was prepared from the blood samples. The serum samples were counted for up to 50 minines each in a Beckman CPM-100 liquid scintillation counter. Counting efficiency was determined from a previously prepared external standard quench correction curve.
Results and discussion
- Absorption in different matrices:
- Counts in serum from rabbits pretreated with lauryl sulphate were 3-45 times greater than in blank serum. In the untreated rabbits, many of the counts were less than twice blank.
Mean levels in the pretreated rabbits were roughly 10 times levels in the untreated animals. The highest single concentration obtained in any animal whilst in the stocks was 3.4 % dose/rabbit in pretreated animals, and 0.16% in intact animals.
Any other information on results incl. tables
The % dose absorbed was calculated assuming a distribution volume of 1 L/kg and was in pretreated rabbits 0.2-3.4% dose/rabbit and 0.02-0.16% in intact animals.
Mean % dose/rabbit at various time after dosing
Rabbit | 2 hours | 4 hours | 6 hours | 8 hours | 24 hours |
1 - pretreated | 0.547 | 0.702 | 3.357 | 0.790 | 1.824* |
2 - pretreated | 2.023 | 0.911 | 1.195 | 1.174 | 0.737 |
3 - pretreated | 0.300 | 0.965 | 0.356 | 0.322 | 0.200 |
4 - pretreated | 0.692 | 0.694 | 0.630 | 0.416 | 0.210 |
Mean - pretreated | 0.891 | 0.818 | 1.454 | 0.676 | 0.743 |
5 - unchanged skin | 0.033 | 0.116 | 0.088 | 0.101 | 2.284* |
6 - unchanged skin | 0.040 | 0.078 | 0.076 | 0.084 | 0.069 |
7 - unchanged skin | 0.045 | 0.047 | 0.114 | 0.065 | 0.155 |
8 - unchanged skin | 0.015 | Not valid | 0.028 | 0.020 | 0.073 |
Mean - unchanged skin | 0.033 | 0.080 | 0.077 | 0.068 | 0.0645 |
* Removed from stocks after 8 hours
Only blood samples obtained at times when the rabbit is confined in stocks are a valid expression of cutaneous absorption, since samples obtained later (48 hour) were in general higher and this is taken as evidence of oral absorption.
Counts in serum from rabbits pretreated with lauryl sulphate were 3-45 times greater than in blank serum. In the untreated rabbits, many of the counts were less than twice blank.
Mean levels in the pretreated rabbits were roughly 10 times levels in the untreated animals. The highest single concentration obtained in any animal whilst in the stocks was 3.4 % dose/rabbit in pretreated animals, and 0.16% in intact animals.
Applicant's summary and conclusion
- Conclusions:
- The dermal absorption of sodium fusidate is very low, 0.02-0.16% based on results from a study in rabbits.
- Executive summary:
A dermal absorption study Study with eight male rabbits (New Zealand White) was performed. An area 6 cm x 10cm was shaved on the back of the rabbits. Four of the rabbits were treated with 1% sodium lauryl sulphate in vaseline. the remaining four rabbits were untreated. After 24 hours ca. 1g of salve was applied to the shaved area of all 8 rabbits. Blood samples were taken after 0,2,4,6,8,24 and 48 hours after application.
Serum levels in pretreated rabbits were 3-45 times greater than in blank serum. Levels in animals with intact skin were substantially lower.
The % dose absorbed was calculated assuming a distribution volume of 1 L/kg and was in pretreated rabbits 0.2-3.4% dose/rabbit and 0.02-0.16% in intact animals.
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.