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EC number: 232-380-0 | CAS number: 8011-86-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 34905.
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- Since December 12,1988 to January 5, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the validation of LLNA OECD method and is considered to be valid and acceptable for the assessment.
Test material
- Reference substance name:
- Similar substance 1
- IUPAC Name:
- Similar substance 1
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: males : 7 weeks females: 8 weeks
- Weight at study initiation: males: 416 - 461 g females: 409 - 459 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet : Pelleted standard Kliba 342, Batch 47188 guinea pig breeding/ maintenance diet, ad libitum.
- Water: tap water , ad libitum.
- Acclimation period: One week under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3°C
- Humidity (%):40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark, music/tight period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1, 0.3, 0.5, 1, 3 and 5 % of the test article in petrolatum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.1, 0.3, 0.5, 1, 3 and 5 % of the test article in petrolatum
- No. of animals per dose:
- 5 x sex x dose (control)
10 x sex x dose - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE: injection
- No. of exposures: 6
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/ site) were made at the border of a 4 x 6 cm area in the clipped region
- Concentrations: 0.1 , 0.3, 1, 3, and 5% test item in petrolatum
INDUCTION EXPOSURE: One week after the injections
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 10 males and 10 females
- Control group: 5 males and 5 females
- Site: (6 x 8 cm)
- Type of coverage: filter paper was saturated with the test article (5 % in petrolatum) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wound round the trunk of the animal and secured with impervious adhesive tape.
- Duration: 24 hours
- Concentrations: 5% in petrolatum
B. CHALLENGE EXPOSURE: The test and control guinea-pigs were challenged two weeks after the epidermal induction application.
- No. of exposures:2
- Exposure period: approximately 24 hours later
- Test groups:10 males and 10 females
- Control group:5 males and 5 females
- Site:hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig.
- Type of coverage: Two patches (2 x 2 cm) of filter paper
- Concentrations:3 % in petrolatum oil
- Evaluation : 0, 24, 48 hrs
OTHER OBSERVATION:
Mortality/Viability: Once daily
Body Weights: At acclimatization start, start of application and end of test.
Symptoms (local systemic): daily
Necropsy: no
All animals were killed at the end of the test period with an intraperitoneal injection of T61 (Hoechst AG) and discarded.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic symptoms were observed.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No systemic symptoms were observed..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No systemic symptoms were observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 6
- Total no. in group:
- 9
- Clinical observations:
- none
- Remarks on result:
- other: A control group (Binitro-choloro-benzene) is tested twice a year as a sensitivity check of the guinea pig strain. The most recent test was run during September 1988.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The analogue substance was tested for skin sensitization following OECD 406. Under the experimental conditons the substance is not classified as skin sensitizer
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of the analogue substance when administered to the skin of male and female albino guinea pigs.
For this purpose the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten animals (5 males, 5 females) were treated with the vehicle alone (petrolatum oil) and 20 animals (10 males, 10 females) were treated with the test article.
The study was conducted between December 5th and January 5th, 1989 at the RCC laboratories in 4452 Itingen/Switzerland.
If necessary prior to the first reading of the reactions, the skin was flushed with the vehicle or other solvents to clean the application site from staining produced by the test article, so that the reactions (erythema) were clearly visible at that time. Due to the unequivocal findings observed after the first challenge, no second challenge was performed.
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