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EC number: 400-920-6 | CAS number: 89857-06-7
- 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:
- From April 15th to May 23rd, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- EWG Directive 84/449/ EWG, Amtsblatt der Europaeischen Gemein-schaften L 251, Jahrgang 27, 19. 9. 84. B.6. Akute Toxizitaet - Sensibilisierung der Haut / 113
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig maximisation test was available
Test material
- Reference substance name:
- -
- EC Number:
- 400-920-6
- EC Name:
- -
- Cas Number:
- 89857-06-7
- Molecular formula:
- C50 H53 N11 O14 S
- IUPAC Name:
- 5'-[2-(7-{2-[4-(2-{1'-[3-(dimethylazaniumyl)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-8-hydroxy-6-sulfonatonaphthalen-2-yl)diazen-1-yl]-6'-hydroxy-3,4'-dimethyl-2'-oxo-1',2'-dihydro-1λ⁵-[1,3'-bipyridin]-1-ylium bis(2-hydroxypropanoate)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- DUHA KFM
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Kieintierfarm Madoerin AG CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 372 - 452 g males; 346 - 464 g females
- Housing: individually in Makrolon type-3 cages with standard softwood bedding
- Diet: peIIeted standard Kliba 342, Batch 21/85 and 22/85 guinea pig breeding/maintenance diet ad libitum
- Water: communlty tap water from Itingen, ad libitum
- Acclimation period: six days under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Air changes: 10-15 per hour
- Photoperiod: 12 hours artificial fluoscent light/12 hours dark, music/light period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: FCA with physiological saline
- Concentration / amount:
- FCA, 50:50 with physiological saline
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 3%
- Route:
- intradermal
- Vehicle:
- other: FCA
- Concentration / amount:
- 50:50 mixture of FCA
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 8
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 25%
- No. of animals per dose:
- Test article group: 10 males/10 females
Negative control group: 5 males/5 females - Details on study design:
- PRELIMINARY STUDY
The objective of this investigation was to identify irritant test article concentrations suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
The procedure employed for these investigation was as follows:
Intradermal injections:
Intradermal injections (0,1 mI/site) were made into the clipped flank of four guinea-pigs at concentrations of 5, 3, 1 and 0.5 %. of the test article in physiological saline. The resulting dermal reactions were assessed 24 hours later.
The following parameters were recorded:
Erythema (E) - 0 to 4 numerical scores
Edema (0) - 0 to 4 numerical scores
Diameter (D) - mm
Erythema and edema were assessed using the following arbitrary scales:
Erythema and eschar formation
No erythema 0
Slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation
No edema 0
Slight edema (barely perceptible) 1
Well-defined edema (edges of area well-defiend by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) 4
Topical applications :
Patches of filter paper (2 x 2 cm) were saturated with concentrations of 10 and 25% of the test article in physiological saline and applied to the clipped and shaved flanks of each of four guinea-pigs tested concentrations. The patches were covered by a strip of aluminium 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 the scale described above. Further examination of the sites were performed 24 and 48 hours after removal of the dressings.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections:
An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 4 cm area in the clipped region as follows:
1) Freunds' complete adjuvant 50:50 with physiological saline for injection.
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 Freunds' complete adjuvant, and the vehicle used in (2).
Topical applications:
0ne week after the injections, the scapular area was again clipped and shaved free of hair. A 4 x 4 cm patch of filter paper was saturated with the test article (25%) and placed over the injection sites of the test animals. The patch was covered by aIuminium foil and firmly secured by an elastlc plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were Ieft in place for approximately 48 hours.
The guinea-pigs of the control group received identical treatment without the test article.
B. CHALLENGE EXPOSURE
The test and control guinea-pigs were challenged two weeks after the topical induction application. Hair was clipped and shaved from a 5 x 5 cm area on the left flank of each guinea-pig. A 2 x 2 cm patch of filter paper was saturated with a non-irritant concentration (25%) of the test article and applied to the flank in a similar method to that used for the topical application.
The dressings wre removed approximately 24 hours later. The sites were assessed for erythema using the arbitrary scale. The control animals were treated with the vehicle alone.
Re-challenge
A second challenge was performed two weeks after the first challenge. The method was similar to that described for the first challenge with the exception that the right flanks of aII the guinea-pigs were used. The control animals were treated with the test article in the same concentration as the animals of the test group to avoid wrong positive results.
OBSERVATIONS
Mortality/Viability: once daily
Body weights: at pre-treatment start, start of application and end of test
Toxic Symptoms: daily
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 25
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
NEGATIVE CONTROL
No positive reactions were evident after the first and second challenge application.
TEST ARTICLE
After the first and second challenge application a bluish dicoloration was observed. No other symptoms or skin sensitizing effects were evident after the 24- and-l 48-hour reading.
VIABILITY/MORTALITY
Animal No. 74 (female) was replaced at day 1 of test due to incidental death.
SYMPTOMS
LOCAL
Control group
Application area around the injections of series 1 and 3 were found to show wrythema and edema in any animal of the control group between days 2 and 4 of test. Starting with day 5 to 12 of test aditionally crusts were observed. Crusts were observed between days 13 and 22. Exfoliation was observed between days 23 to 26. These findings showed a clear healing tendency during the remaining test period.
Test article group
The animals of the test article-treated group showed the same reactions as described above.
SYSTEMIC
No systemic symptoms were observed.
BODY WEIGHTS
The body weight gain of all animals was not affected by the test procedure.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified for skin sensitisation according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- Non sensitizer.
- Executive summary:
The allergenic potential of test substance was assessed in albino guinea pigs by the maximization-test of B. Magnusson and A.M. Kligman (1969), as per OECD guideline 406. Five males and five females were used as control group and 10 males and 10 females were used as test group. The highest non-irritating test article concentration used for challenge application was 25%.
According to the procedures used in this experiment, no differences between the test group and the vehicle-treated controls were evident after epidermal challenge application of test item. The substance is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs. The incidence of positive reactions after epicutaneous challenge were as follows:
POSITIVE ERYTHEMA REACTIONS AFTER 1ST CHALLENGE PROCEDURE
after 24 h after 48 h
total total
positive negative positive negative
Test substance 0 20 0 20
(%) positive reaction/total animals 0 0
Vehicle control 0 10 0 10
(%) positive reaction/total animals 0 0After the second challenge application the following positive results were observed in the animals of the test article treated group:
after the 24-hour reading: 0 (0%)
after the 48-hour reading: 0 (0%)
No toxic symptoms were evident in the guinea pigs of either the control and test group.In conclusion, 0% of the animals were positive after treatment with the non-irritating test substance concentration of 25%. Therefore the test article is considered to be a non sensitizer.
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