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EC number: 264-497-8 | CAS number: 63817-45-8
- 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
- Study period:
- January 15th to March 1st, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method was not available
Test material
- Reference substance name:
- 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate
- EC Number:
- 296-673-5
- EC Name:
- 6-chloro-2-[4-[ethyl(2-hydroxyethyl)amino]phenyl]-1-methylbenz[cd]indolium acetate
- Cas Number:
- 92952-73-3
- Molecular formula:
- C22H22ClN2O.C2H3O2
- IUPAC Name:
- 6-chloro-2-{4-[ethyl(2-hydroxyethyl)amino]phenyl}-1-methylbenzo[cd]indolium acetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Blue 145
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Remarks:
- Ibm: GOHI
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males 7 weeks females: 8 weeks
- Weight at study initiation: males: 401 - 479 g females: 353 - 449 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Diet Pelleted standard Kliba 342 guinea pig breeding/ maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid via the drinking water.
- 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 (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- Test group: Three pairs of intradermal injections (0.1 ml/site)
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5% with ethanol.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle used in (2).
Control Group: Three pairs of intradermal injections (0.1 ml/site)
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water. - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25 % / a 2 x 4 cm patch of filter paper was saturated with the test article
- Day(s)/duration:
- Day 8 - for 48 hours
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25 % / a 2 x 2 cm patch of filter paper, saturated with the test article
- Day(s)/duration:
- Day 22 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25% / saturated filter paper (2 x 2 cm)
- Day(s)/duration:
- Day 36 - for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 males, 5 females for the control group and 10 males, 10 females for the test group
- Details on study design:
- RANGE FINDING TESTS:
Intradermal concentration: Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5%, 3% and 1% of the test article in ethanol. The resulting dermal reactions were assessed 24 hours later.
Epidermal concentrations: Patches of filter paper (2 x 2 cm) were saturated with concentrations of 25%, 15%, 10% and 5% of the test article in ethanol and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema on a numerical basis according to the scale described above. Further examination of the sites were performed 24 and 48 hours after removal of the dressings.
Prior to the readings the test sites were depilated.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections:
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 as follows:
Test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5% with ethanol.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle used in (2).
Control Group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water.
Epidermal applications:
One week after the injections, the scapular area (approximately 6 x 8 cm) was again clipped and shaved free of hair. A 2 x 4 cm patch of filter paper was saturated with the test article (25% in ethanol) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for approximately 48 hours. The epidermal application procedure des¬cribed ensured intensive contact of the test article.
Approximately 24 hours prior to the epidermal application the test area was be pretreated with 10 % Sodium-Lauryl-Sulfat (SLS) in petrolatum-oil. The SLS was massaged into the skin with a glass rod without bandaging. This concentration of SLS enhances sensitization by provoking a mild inflammatory reaction.
The guinea-pigs of the control group were treated as described above with the omission of test article.
Reaction sites were assessed for erythema and edema immediately, 24 and 48 hours after removal of the dressing
B. CHALLENGE EXPOSURE
The test and control guinea-pigs were challenged two weeks after the epidermal induction application.
Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea-pig. Two patches (2 x 2 cm) of filter paper were saturated with a) non-irritant concentration (25% in ethanol) of the test article and b) with the vehicle only and applied to the (a) left flank and (b) right flank using the same method as for the epidermal application.
The dressings were removed approximately 24 hours later. The sites were assessed for erythema and edema immediately, 24 and 48 hours after removal of the dres-sing, using the numerical scoring system as described under preliminary study.
Prior to the first reading, the test sites were depilated.
The control animals were treated in the same way as described above.
Re-challenge
A second challenge was performed two weeks after the first challenge.
The treatment procedure for the animals of the test group was similar as described for the first challenge with the exception that the flanks of all the guinea-pigs were changed (a - vehicle; b - test article dilution).
The control animals were treated with the vehicle alone on the left flank.
OTHER:
In addition to the sensitizing reactions the following observations and data were recorded during the test and observation period:
Mortality/Viability: Once daily.
Body Weights: At acclimatization start, start of application and termination of test.
Symptoms (local/systemic): Daily. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- HCHO
Results and discussion
- Positive control results:
- clear positive results were observed in the HCHO treated animals after the epidermal challenge application in 90% of the animals
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- etanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Only the 24-hour assessment in the first challenge met the cut-off value for a positive skin sensitization reaction. At all other evaluation time-points the threshold for a skin sensitiser was not met. Hence, the test substance was not considered to be a skin sensitiser.
- Executive summary:
To assess the allergenic potential of the test substance in albino guinea pigs, the Maximization-Test of Magnusson & Kligman according to OECD Test Guideline 406 was conducted. Ten animals (5 males, 5 females) were used as control group and 20 animals (10 males, 10 females) were used as test group.
Prior to the first reading of the reactions, the skin was depilated to clean the application site from staining produced by the test article, so that the reactions (erythema) were clearly visible at that time.
The highest non-irritating concentration used for both challenge applications was 25%.
After the first challenge 6/20 (30%) animals showed a positive reaction at the 24-hour assessment and 5/20 (25%) at the 48-hour assessment. As no clear assessment for sensitizing properties can be made from the results of the first challenge (at least 30% positive animals), a second challenge with the same concentration was conducted in the same animals 14 days after the first challenge. After the re-challenge 5/20 (25%) animals showed a positive reaction at the 24-hour assessment and 4/20 (20%) at the 48-hour assessment.
No clinical signs were evident in the guinea pigs of either the control or test group. No deaths occurred.
Only the 24-hour assessment in the first challenge met the cut-off value for a positive skin sensitization reaction. At all other evaluation time-points the threshold for a skin sensitiser was not met. Hence, the test substance was not considered to be a skin sensitiser.
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