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EC number: 273-454-2 | CAS number: 68966-87-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method was not available at the time of testing
Test material
- Reference substance name:
- Ostalanova sed BL
- IUPAC Name:
- Ostalanova sed BL
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- non pregnant and nulliparous
At delivery, the veterinary certificate guaranteeing the declared medical condition of experimental animals are carriers of the parasite pathogenic microorganisms viruses and fungi
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5% in water pro injection
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5% in water pro injection
- Details on study design:
- RANGE FINDING TESTS: Animals were exposed to patch test substances at 25% in petroleum, 5%, % and 0,5% in water pro injection on the side with for 24 hours. 1 h after removal of dressing the local irritation was assessed. The results show that a concentration more than 0.5% of Ostolanova sed BL in water for injection is skin irritating to guinea pigs.
MAIN STUDY
A. INDUCTION EXPOSURE intradermal
- No. of exposures: 2 replicate for each injection
- Test groups: 20 females
- Control group: 10 females
- Site: neck
- Concentrations:
injection #1 test group: Freund's complete adjuvant
injection #2 test group: 0.5% ostalanova sed in water for injection
injection #3 test group: 0.5% ostalanova sed in complete Freund's adjuvant
injection #1 control group: Freund's complete adjuvant
injection #2 control group: water for injection
injection #3 control group: 50% Freund's complete adjuvant + 50% water for injection
INDUCTION EXPOSURE PATCH
- Day of exposure: 7th day
- Exposure period: 48h
- Site: neck, identical position of the intradermal application
- Concentrations:
test group: 2x4 cm of filter paper nrushed with 25% Ostalanovou BLm in white petroleum in occlusive dressing
control group: 2x4 cm of filter paper of white petroleum in occlusive dressing
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 20th and 27th day
- Exposure period: 72h
- Test groups: 2x2 cm impregnated of test substance with occlusive dressing
- Site: right flank for exposure 1 and left flank for exposure 2
- Concentrations: 0.5% Ostolanova BL in water
- Evaluation (hr after challenge): 24h
-the site of application was washed with water
OTHER: - Challenge controls:
- The same conditions as the experimental group
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- n.a.
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The sample was tested for skin sensitization potential following OECD 406. Albino guinea-pigs were used as the experimental animals. The test results show that the test substance for guinea pigs, is not a skin contact allergen.
- Executive summary:
The sample was tested for skin sensitization potential following OECD 406. Albino guinea-pigs were used as the experimental animals. An intradermal and patch induction were used, and the susbtance was challenged at 20th and rechallnged at 27h day of exposure. The substance was tested at a concentration of 0.5% in water pro-injection with an occlusive dressing and dermal reaction were evaluated after 24h after its removal and after 72h of expoure.
There were no positive skin reactions at the first or repeated induced hypersensitive response. There was no difference in the growth and development of animals between experimental and control groups.
No animal showed any allergenic skin reaction and the substance is not considered as a skin contact allergen.
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