Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 278-108-4 | CAS number: 75199-00-7
- 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:
- 1989-03-28 to 1989-08-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing data from 1989
Test material
- Reference substance name:
- Trisodium 4-[[4-[[(2,3-dichloro-6-quinoxalinyl)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazole-3-carboxylate
- EC Number:
- 278-108-4
- EC Name:
- Trisodium 4-[[4-[[(2,3-dichloro-6-quinoxalinyl)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazole-3-carboxylate
- Cas Number:
- 75199-00-7
- Molecular formula:
- C25H15Cl2N7O10S2.3Na
- IUPAC Name:
- trisodium 4-[(E)-2-[4-(2,3-dichloroquinoxaline-6-amido)-2-sulfophenyl]diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 27
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, Borchen, Germany
- Microbiological status of animals, when known: SPF
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: Mean: 348 g (from 314 to 393 g)
- Housing: Animals (5 animals per cage) were housed in type IV Makrolon® cages with low-dust granula (Ssniff Spezialdiäten GmbH, Soest, Germany). The animal room was cleaned once per week and disinfected once per month. Contamination of the feed and the animals was excluded.
- Diet (e.g. ad libitum): Diet "Altromin 3022 - Haltungsdiät für Meerschweinchen", ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: Only healthy, symptom-free animals were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% in physiological saline
- Day(s)/duration:
- single application
- Adequacy of induction:
- other: based on the results of a pre-test
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25% in physiological saline
- Day(s)/duration:
- single application, one week after intradermal induction
- Adequacy of induction:
- highest technically applicable concentration used
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration: 25%
Amount: 0.5 mL - Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Concentration: 12 and 2.5%
Amount: 0.5 mL - Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 guinea pigs in the test group, 10 in the control group
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal application:
One guinea pig received intradermally 0.1 mL of the following test item concentrations: 0, 1, 2.5 and 5%. The injection sites were assessed 24 and 48 h after application. For results please refer to box "Any other information on results incl. tables".
- Epicutaneous application:
4 guinea pigs received under occlusive conditions each of the following test item concentrations: 3%, 6%, 12% and 25% for 24 h. The application sites were assessed after 48 and 72 h.
For results please refer to box "Any other information on results incl. tables".
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal application
- No. of exposures: 1
- Test groups:
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region so that one of each pair lies on each side of the midline.
Injection 1 (cranial): a 1:1 mixture (v/v) FCA/ physiological saline
Injection 2 (medial): 5% suspension of the test material formulated in physiological saline
Injection 3 (caudal): 5% suspension of the test material formulated in a 1:1 mixture (v/v) FCA/ physiological saline
- Control group:
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region so that one of each pair lies on each side of the midline.
Injection 1 (cranial): a 1:1 mixture (v/v) FCA/ physiological saline
Injection 2 (medial): physiological saline
Injection 3 (caudal): physiological saline in a 1:1 mixture (v/v) FCA/ physiological saline.
- Frequency of applications: 1
Epicutaneous application
- No. of exposures: 1
- Exposure period: 48 h
One day before exposure, the application sites have been clipped and coated with 0.2 mL of a 10% preparation of sodium lauryl sulfate solution in paraffin oil.
A hypoallergenic band-aid (2 x 4 cm) impregnated with 0.5 mL of the test suspension (25 % test material in physiological saline (test group) or physiological saline (control)) was put on the injection sites of the intradermal application, covered with aluminum foil and fixed for 48 h using a Fermoflex tape (Transatlantic GmbH, Schwarzenbach). At the end of the exposure period the substance was removed using physiological saline.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21 and 28 days after intradermal induction
- Exposure period: 24 h
One day before exposure, the application sites have been clipped. Two hypoallergenic band-aids 2 x 4 cm), impregnated with 0.5 mL of the test item suspension (25% test material in physiological saline), were applied to the left flank of all animals (test and first control group) and fixed for 24 h using Saniplast-bandage.
For the second challenge, animals (test and second control group) have been applied two hypoallergenic band-aids impregnated with 0.5 mL of the test item suspension (12 and 2.5% test material in physiological saline) were applied to the left flank and fixed using a Fermoflex tape (Transatlantic GmbH, Schwarzenbach). In the two concentrations and alternating from animal to animal, the patches were applied cranially or caudally. On the right flank two control plaster were applied, soaked with physiological saline (0.5 mL application volume). At the end of the exposure time, application sites have been chemically depilated using Pilca-Creme (Olivin GmbH, Hamburg, Germany).
- Concentrations: 25% (1. Challenge, 21 days after intradermal induction), 12 and 2.5% (2. Challenge, 28 days after intradermal injection)
- Evaluation (hr after challenge): 48 and 72 h
- Scoring: The skin reaction has been scored as proposed by Magnusson and Kligman (see Table 1 in box "Any other information on material and methods incl. tables") - Challenge controls:
- 10 animals previously treated with the vehicle were challenged together with the test group using the same test article concentration as for the test group.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- n.a.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 13 animals showed discrete or patchy erythema, 5 showed moderate and confluent erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- 12 animals showed discrete or patchy erythema, two animals showed additionally scaly skin. 4 animals showed moderate and confluent erythema, two animals showed additionally scaly skin.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Clinical observations:
- 12 animals showed discrete or patchy erythema, some animals showed additionally parts of scaly (n=6) and encrustion skin (1 animal). 3 animals showed moderate and confluent erythema, with partly scaly skin. 1 animal only showed partly scaly skin
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- 9 animals showed discrete or patchy erythema, with additionaly scaly skin. One animal showed only partly scaly skin.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- 10 animals showed discrete or patchy erythema, three of them showed additionally partly scaly skin. 2 animals showed moderate and confluent erythema, and adiditionallly partly encrustation of the skin (n=1) or scaly skin (n=1).
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 5 animals showed discrete or patchy erythema, 3 of them showed additionally partly scaly skin.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Results of the pre-test
- Intradermal induction
After 24 hours the skin around the injection side were dyed golden-yellow
- Topical induction
Table 2: Results for skin reaction after topical application in the pre-test
Animal No. | Test material concentration | |||||||
3% | 6% | 12% | 25% | |||||
48 h | 72 h | 48 h | 72 h | 48 h | 72 h | 48 h | 72 h | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Further observations:
No animals died during the experimantal phase and the body weight gain was comparable to the control animals.
Results of the main test
Table 3: Individual results of the 1. Challenge
Animal No. |
Test material concentration |
|
25% |
||
48 h |
72 h |
|
1. Control group |
||
1 |
0 |
0 |
2 |
0 |
0 |
3 |
0 |
0 |
4 |
0 |
0 |
5 |
0 |
0 |
6 |
0 |
0 |
7 |
0 |
0 |
8 |
0 |
0 |
9 |
0 |
0 |
10 |
0 |
0 |
Test group |
||
21 |
1 |
1 |
22 |
2 |
1 |
23 |
1 |
1 |
24 |
1 |
1 |
25 |
1 |
1 |
26 |
2 |
2 |
27 |
2 |
2* |
28 |
0 |
0 |
29 |
1 |
1 |
30 |
0 |
0 |
31 |
1 |
1* |
32 |
2 |
2 |
33 |
1 |
1* |
34 |
1 |
0 |
35 |
1 |
0 |
36 |
1 |
1 |
37 |
1 |
1 |
38 |
1 |
1 |
39 |
2 |
2* |
40 |
1 |
1 |
* = Application site partly scaly
Table 4: Individual results of the 2. Challenge
Animal No. |
Test material concentration |
|||
12% |
2.5% |
|||
48 h |
72 h |
48 h |
72 h |
|
1. Control group |
||||
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
0 |
9 |
0 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
Test group |
||||
|
|
|
|
|
21 |
1+* |
1* |
1* |
1* |
22 |
1* |
1* |
1 |
0 |
23 |
1 |
0 |
1 |
0 |
24 |
1 |
1 |
1 |
0 |
25 |
1 |
1 |
1 |
0 |
26 |
1* |
0 |
0 |
0 |
27 |
2* |
1* |
2* |
1* |
28 |
1* |
1 |
0 |
0 |
29 |
1 |
0 |
1 |
0 |
30 |
0 |
0 |
0 |
0 |
31 |
1* |
0* |
1* |
0 |
32 |
2* |
1* |
1* |
1 |
33 |
1 |
0 |
0 |
0 |
34 |
1 |
0 |
1 |
0 |
35 |
0 |
0 |
0 |
0 |
36 |
0* |
0* |
0 |
0 |
37 |
1* |
1* |
1 |
1 |
38 |
0 |
0 |
0 |
0 |
39 |
2* |
1* |
2+ |
1* |
40 |
0 |
0 |
0 |
0 |
* = Application site partly scaly
+ = Application site partly encrusted
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In conclusion, based on the results obtained from a dermal skin sensitisation test, the test item can be considered as a dermal sensitizer.
- Executive summary:
In a dermal sensitization study conducted according to OECD 406, young female BOR : DHPW guinea pigs (20 animals/test group & 10 animals/control) were tested using the Guinea Pig Maximisation Test according to Magnusson and Kligman. The animals received intradermally 5% of the test item in physiological saline. One week after the intradermal induction, the animals received the second induction by applying the test item as a 25% suspension in physiological saline topically. Three weeks after the intradermal induction, the animals were challenged with a 25% suspension in physiological saline of the test item. The animals of the control group were not treated during the induction, but were treated once at each challenge. After the first challenge the treatment group showed erythema at the application site. Moreover, in the treatment groups scales of the skin were observed. In the control group no indication of skin sensitisation occurred.
During a second challenge the animals were treated with either 12% or 2.5% suspensions in physiological saline. During the re-challenge, erythema and encrustations of the skin were only observed in the treatment groups. No effects were observed in the control group animals. Therefore, based on the results obtained, the test item can be considered as a dermal sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.