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Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]
EC number: 939-268-7 | CAS number: -
- 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: experimental data on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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:
- Valid guideline used
Test material
- Reference substance name:
- Similar Substance 02
- IUPAC Name:
- Similar Substance 02
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: males: 7 weeks, females: 8 weeks
- Weight at study initiation: males: 308 - 355 g, females: 297 - 412 g
- Housing: Individually in Makrolon type-3 cages
- Diet: Pelleted standard Kliba 342, Batch 57/90 guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water: tap water ad libitum; once weekly additional supply of ascorbic acid via the drinking water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 3%
Epicutaneous induction: 15%
Challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 3%
Epicutaneous induction: 15%
Challenge: 10%
- No. of animals per dose:
- Control group: 5 males + 5 females
Test group: 10 males + 10 females - Details on study design:
- RANGE FINDING TESTS:
Intradermal injections: 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 physiological saline. The resulting dermal reactions were assessed 24 hours later.
Epidermal applications: Patches of filter paper (2 cm x 2 cm) were saturated with concentrations of 25%, 15%, 10% and 5% of the test article in physiological saline 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. 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 Draize. Further examination of the sites were performed 24 and 48 hours after removal of the dressings. Prior to the first reading, the test sites were depilated to clean of excess test article.
MAIN STUDY
A. INDUCTION EXPOSURE
- Intradermal injections:
An area of dorsal skin from the scapular region (approximately 6 cm 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 cm 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 3% with physiological saline
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 cm x 8 cm) was again clipped and shaved free of hair. A 2 cm x 4 cm patch of filter paper was saturated with the test article (15% in physiological saline) 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 described ensured intensive contact of the test article. 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, using the numerical grading system according to Draize.
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 cm x 5 cm area on the left and right flank of each guinea-pig. Two patches (2 cm x 2 cm) of filter paper were saturated with a) non-irritant concentration (10% in physiological saline) 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 dressing, using the numerical scoring system according to Draize. The control animals were treated in the same way as described above. Prior to the first reading the test sites were depilated to clean of excess test article. - Challenge controls:
- A control group (Formaldehyde-solution) is tested twice a year in the testing laboratory for sensitivity check of the guinea pig strain. The most recent test was run between November and December, 1989.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% in physiol. saline
- 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: 10% in physiol. saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% in physiol. saline
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% in physiol. saline. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% in physiol. saline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% in physiol. saline. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in physiol. saline
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in physiol. saline. No with. + reactions: 1.0. Total no. in groups: 20.0.
Any other information on results incl. tables
The highest non-irritating concentration used for challenge application was 10%. No toxic symptoms were evident in the guinea pigs of neither the control nor test group. No death occurred.
Positive erythema reactions after first challenge procedure (due to the unequivocal findings observed after the first challenge, no second challenge was performed):
|
after 24 hours |
after 48 hours |
||
|
positive |
total |
positive |
total |
|
% positive of total |
% positive of total |
||
CONTROL GROUP |
|
|
|
|
Test substance (left flank) |
0 |
10 |
0 |
10 |
0 |
0 |
|||
Vehicle (right flank) |
0 |
10 |
0 |
10 |
0 |
0 |
|||
|
|
|
|
|
TEST GROUP |
|
|
|
|
Test substance (left flank) |
2 |
20 |
1 |
20 |
10 |
5 |
|||
Vehicle (right flank) |
0 |
20 |
0 |
20 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- From the results of this study no allergenic potency of the test article was concluded.
- Executive summary:
The study followed OECD guideline 406 (1983) and the principles of GLP. The purity of the test item is 94.6%. Each five male and female albino guinea pigs were used in control groups and each ten male and female animals in the test group. For intradermal injections of the test group, 0.1 ml of a 3% solution in PBS, Freund’s complete adjuvant (50:50) or 3% in Freud’s adjuvant was used. For challenge one week later, the highest non-irritating dose of 10% was used. One day after challenge, 2/20 showed a positive reaction for erythema compared to 0/10 in the control group. After two days, 1/20 animals showed a positive reaction compared to 0/10 in the control group.
Conclusion: From the results of this study no allergenic potency of the test article was concluded.
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