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EC number: 474-870-9 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 April 2007 to 23 May 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- Study was already available
Test material
- Reference substance name:
- -
- EC Number:
- 474-870-9
- EC Name:
- -
- Cas Number:
- 80156-97-4
- Molecular formula:
- Hill formula: C28H20ClN9Na4O16S5 CAS formula: C28H24ClN9O16S5.4Na
- IUPAC Name:
- tetrasodium 7-[(1E)-2-[2-(carbamoylamino)-4-{[4-chloro-6-({4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}phenyl]diazen-1-yl]naphthalene-1,3,6-trisulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reactive Yellow 176 Ester
Reactive Yellow 176 Sulfato
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Species and strain: Guinea pigs, Dunkin Hartley
Source: LAB-ÁLL Bt. Budapest, 1174 Hunyadi u. 7.
Justification of the strain: The guinea pig is the standard species for skin sensitisation study.
Sex: Female
Weight range at the beginning of the study: 300-346 g
Acclimatization time: 14 days
Date of animal receipt: 12 April 2007
Animal health: Only animals in acceptable health condition were used for the test. It is certified by the veterinarian.
Cage type: Animals were housed in macrolon cages, size III., with 3 or 2 animals/cage (42 x 42 x 19 cm)
Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasern
Produced by: SSNIFF Specialdiaten GmbH, Ferd.-Gabriel-weg 16, 59494 Soest
Animal room: 602/8
Light: 12 hours daily from 6 a.m. to 6 p.m. (artificial light)
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Food and Feeding: Animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
Water Supply: The animals received tap water, as for human consumption, ad libitum containing 50 mg/100 ml Ascorbic acid. The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Identification: The animals were marked individually with ear punching. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% / 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50% / 0.5 mL
50% was the highest technically apllicable concentration - Day(s)/duration:
- Day 8 for 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50% / 0.5 mL
- Day(s)/duration:
- Day 22 for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Range finding study: 2 animals/two concentrations (in one animal two concentrations were tested: one concentration in the left side, and other concentration in the right side).
Main study:
Test groups: 10 animals
Control group: 5 animals - Details on study design:
- Control animals were treated similarly to test animals, except that during the induction phase, the test item was omitted.
Induction involved two main procedures: intra-dermal treatments (Main Study I) and dermal exposure (Main Study II) with closed patch technique. The intra-dermal and the dermal induction treatments were observed and recorded. Records are archived with the raw data.
Main Study I: Intra-dermal Induction Exposure
Before starting the exposure an area of approximately 5 x 5 cm on the scapular region of animals was clipped free of hair and shaven close with care.
Intra-dermal treatment
Test groups:
A row of three injections, six in all, was made on each side of test animals, as follows:
2 injections with 0.10 ml of Freund's Adjuvant mixed with physiological saline (1:1 v/v),
2 injections with 0.10 ml of the test item (5 %) homogenized in physiological saline,
2 injections with 0.10 ml of test item (5 %), formulated in a 1:1 (v/v) mixture of
Freund's Adjuvant and methyl cellulose (1 %),
Control group:
The control animals were treated similarly as the test group however, the vehicle, without the test item was used for injections, as follows:
2 injections with 0.1 ml mix of Freund's Adjuvant and physiological saline (1:1)(v/v),
2 injections with 0.1 ml of physiological saline,
2 injections with 0.1 ml of 50 w/v% physiological saline, in a 1:1 mixture (v/v) Freund's Adjuvant and physiological saline.
Main study II: Dermal Induction Exposure
Six days after the intra-dermal injections, in all animals the test area was painted with 0.5 ml of 10 % sodium dodecyl sulphate in Vaseline 24 h prior to topical induction application, in order to create a local irritation.
Approximately 24 hours after the painting, the test animals were exposed to test item on the other hand the control animals were treated with physiological saline, as vehicle.
Closed patch was applied in the following manner: in case of the test animals 0.5 ml of test item (at concentration of 50 %) was spread on the surface prepared previously and covered with a standard (5x5 cm) size of porous gauze patch.
Control animals were treated dermally with 0.50 ml of physiological saline, as vehicle and the dressing was prepared and applied as for the test animals.
The exposed areas were covered for 48 hours with porous gauze fastened with "Leucoplast" (Closed Patch Test).
The dermal irritation scores (in case of the preliminary study (primary irritation) and in cases of induction dermal exposures) were evaluated according to the scoring system by Draize. - Challenge controls:
- Main study III: Challenge Exposure
Two weeks after the dermal treatment the animals were exposed to the challenge dose, dermally. 24 hours before the challenge treatment the left and the right flank areas (5x5 cm) of each animal were prepared for application. The challenge was performed as a dermal exposure (Closed Patch Test).
Left shaved flank areas of the animals (both the test and the control) were treated with 0.5 ml of the test item (at concentration of 50 %). The right shaved flank areas were treated with 0.5 ml of physiological saline, in all cases. Implementation was done according to prescriptions. Time of exposure was 24 hours. - Positive control substance(s):
- yes
- Remarks:
- 2-MERCAPTOBENZOTHIAZOLE,
Results and discussion
- Positive control results:
- In the test group 10 animals were treated with the reference item.
After the challenge with the reference item 2-MERCAPTOBENZOTHIAZOLE, positive response was seen in six out of ten animals in the test group (60 %). The mean of the scores were 0.6 and 0.4 according to the 24th and 48th-hour results. The dermal scores represented discrete erythema developed on the skin of sensitised guinea pigs. On the opposite (right) side treated with vehicle no reaction was found.
Five control animals were exposed to a vehicle during induction treatment and they were treated with the reference item on the challenge day only.
No visible changes were found at the 24th and 48th hour examinations. During the challenge exposure, the reference item 2-MERCAPTOBENZOTHIAZOLE (at concentration of 25 % (w/v)) did not evoke primary irritation.
On the basis of the results of the present reliability study, the reference item 2-MERCAPTOBENZOTHIAZOLE evoked positive response in 60 % of the test animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Intra-dermal induction exposure: 0.1% (w/v) Dermal induction treatment: 75% (w/v) Challenge treatment: 25% (w/v)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Intra-dermal induction exposure: 0.1% (w/v) Dermal treatment: 75% (w/v) Challenge treatment: 25% (w/v)
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
(MAIN STUDY III)
DERMAL RESPONSE SCORES FOR GUINEA PIGS CHALLENGED WITH THE TEST ITEM (CONTROL AND TEST GROUP)
(Challenge concentrations: 50%)
TEST ANIMALS |
CONTROL ANIMALS |
||||
ANIMAL NUMBER |
SCORES OF DERMAL REACTION |
ANIMAL NUMBER |
SCORES OF DERMAL REACTION |
||
24 hours |
48 hours |
24 hours |
28 hours |
||
After the patch removal |
After the patch removal |
||||
253 |
0 |
0 |
251 |
0 |
0 |
255 |
0 |
0 |
252 |
0 |
0 |
256 |
0 |
0 |
254 |
0 |
0 |
257 |
0 |
0 |
263 |
0 |
0 |
258 |
0 |
0 |
264 |
0 |
0 |
259 |
0 |
0 |
- |
- |
- |
260 |
0 |
0 |
- |
- |
- |
261 |
0 |
0 |
- |
- |
- |
262 |
0 |
0 |
- |
- |
- |
265 |
0 |
0 |
- |
- |
- |
Mean of scores |
0.00 |
0.00 |
Mean of scores |
0.00 |
0.00 |
Number of positive/number of tested |
0/10 |
0/10 |
Number of positive/number of tested |
0/5 |
0/5 |
Scoring of Skin Sensitisation
0 = no visible change
1 = discrete of patchy erythema
2 = moderate and confluent erythema
3 = intense erythema and swelling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Challenge with test item Gelb Sulfato evoked no positive responses in the test animals sensitised previously. At the same time, none of the animals proved to be positive in the control group. The net response value represented an incidence rate of 0 % and the net score value of 0.00.
According to the net percentage value of positively responded animals and to the net score value of the skin reactions, the test item Gelb Sulfato was classified as a non-sensitiser. - Executive summary:
A skin sensitisation study was performed according to Magnusson-Kligman method using Freund's complete adjuvant technique to evaluate the sensitisation potential of test item Gelb Sulfato.
The study was performed in accordance with the study plan, the OECD Guidelines for Testing of Chemicals No. 406, Directive 96/54 EEC B.6 and the Principles of Good Laboratory Practice (GLP) and reported with a GLP certificate.
10 test animals were subjected to sensitisation procedures in a two-stage operation, i.e. an intra-dermal treatment and a topical application. The test item was used at concentration of 5 % for intra-dermal injections and at concentration of 50 % for dermal sensitisation treatment. Before the dermal exposure the test area was painted with 0.5 ml of 10 % sodium dodecyl sulphate in Vaseline 24 h prior to the topical induction application, in order to create a local irritation. Two weeks following the last induction exposure, a challenge dose (at concentration of 50 %) was administered.
Challenge was performed by dermal application of the test item.
5 control guinea pigs were simultaneously exposed to vehicle during the sensitisation phase and they were treated with the test item (at concentration of 50 %) only in the case of challenge.
Incidence Rate
No signs of contact sensitisation were detected in guinea pigs exposed previously to the test item during experiments.
Intensity of Sensitisation Response
In the control and treated animals the mean of the scores was 0.00 according to the 24th and 48th-hour results.
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