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EC number: 288-950-4 | CAS number: 85940-63-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 17th, 1992 to April 17th, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD-Guideline for testing of chemicals, 406 "Skin Sensitization", Adopted 12 May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- EG-Guideline B.6. Acute Toxicity Sensitization of the Skin of the Directive 84/449/EWG: Commission Directive of 25 April 1984 adapting to technical progress for the sixth time Council Directive 67/548/EWG on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study available is over 12 years old
Test material
- Reference substance name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- EC Number:
- 288-950-4
- EC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Cas Number:
- 85940-63-2
- Molecular formula:
- C22H17N4Na3O13S4
- IUPAC Name:
- 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- No further details specified in the study report.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Test species: Pirbright-White guinea pig
Sex: female
Strain: Hoe: DHPK (SPFLac)
Origin: HOECHST AG, Kastengrund, SPF breeding colony
Body weight at start of Study:
X = 292 g (= 100 %)
x min = 266 g (- 8.9 %)
x max= 313 g (+ 7.2 %)
n 15
Randomisation schemes: 347/91
Animal maintenance: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
Ambient temperature: 22 ± 3 °C
Rel. atmospheric humidity: 55 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: at least 5 days
Diet: Altromin 3112 for guinea pigs and rabbits, ad libitum
Water: tap water in plastic bottles, ad libitum
Animal identification: fur-marking with KMn04 and cage numbering
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1 / Single application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: 50% Freund's Adjuvant
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 1 / Single application
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 8 / 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 22 / 24 hours
- Adequacy of challenge:
- other: No signs of irritation occurred after epicutaneous administration of different test concentrations up to 25%
- No. of animals per dose:
- 10 animals in the treatment group and 5 animals in the control group were used.
- Details on study design:
- Determination of the primary non-irritant concentration
In a dermal-occlusive test for primary skin irritation, each of the following test concentrations was applied to the left flank of two guinea pigs:
25% in isotonic saline
5% in isotonic saline
1 % in isotonic saline
The hair on the left flank of the animals was removed mechanically. 0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch, which was then fixed to the left flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and oedema.
Determining of the tolerance of intradermal injections
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 3 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulder.
site appl. vol. in ml conc. in % vehicle
1 2 X 0.1 5.0 isotonic saline
2 2 X 0.1 1.0 isotonic saline
3 2 X 0.1 0.2 isotonic saline
The injection sites (site 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the animals' shoulder.
Main test for sensitising properties
Chronological description of the test procedure indicating the day, at which procedure was carried out:
Day 0
The body weights of animals were determined.
The guinea pigs were shaved mechanically over a dorsal area of 4 x 6 cm in the vicinity of the shoulders.
Day 1
Intradermal induction treatment
Two intradermal injections per animal of the following preparations.
The injection sites (site 1, 2 and 3) were all within a dorsal area of 2 x 4 cm. The injection sites were left uncovered.
Treated group:
Site 1: 2 x 0.1 ml 50% Freund's Adjuvant
Site 2: 2 X 0.1 ml 5 % solution of test substance in isotonic saline
Site 3: 2 X 0.1 ml 5% solution of test substance in 50% Freund's adjuvant
Control and escort groups:
Site 1: 2 X 0.1 ml 50% Freund's Adjuvant
Site 2: 2 X 0.1 ml isotonic saline
Site 3: 2 X 0.1 ml 50 % Freund's Adjuvant
Days 1-7
The application area was examined for local tolerance. Any systemic toxic effects were recorded.
Day 8
Dermal induction treatment
0.5 ml of the test substance preparation or the vehicle was applied to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The application area was then kept for 48 hours under an occlusive bandage with an impermeable film and an elastic bandage.
Treated group: 25% test substance in isotonic saline
Control and escort group: isotonic saline
Day 10
Occlusive bandage removed.
Irritant effects recorded.
Days 11-21
No treatment of control or treated group.
Test animals kept under observation.
Days 15-18
Challenge treatment of escort group, carried out in same way as that of control and treated groups (see days 22- 25).
Day 22
Dermal challenge treatment
One area of approx. 5 x 5 cm on the left flank was shaved mechanically.
0.5 ml of the test substance preparation was applied to a 2 x 2 cm cellulose patch. The application area was then kept for 24 hours under an occlusive bandage with an impermeable film and an elastic bandage.
Treated and control groups (left flank):
25% Remazol-Brilliantgelb GL FWTR in isotonic saline
Day 23
Occlusive bandage removed.
Day 24
Skin examined.
Day 25
Skin examined.
Body weights of test animals determined. - Challenge controls:
- Not specified in the study report.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Light yellow discolouration
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Light yellow discolouration
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Light yellow discolouration
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Light yellow discolouration
Any other information on results incl. tables
Body weight gains
Animal No. |
Body weight at start of study (g) |
Body weight at end of study (g) |
Increase (%) |
Control group: |
|||
1 2 3 4 5 |
312 291 308 295 288 |
377 370 381 384 370 |
+ 21 + 27 + 24 + 34 + 28 |
Treated group: |
|||
6 7 8 9 10 11 12 13 14 15 |
300 276 266 295 272 288 280 303 289 313 |
373 359 354 378 337 350 346 369 349 396 |
+ 24 + 30 + 33 + 28 + 24 + 22 + 24 + 22 + 21 + 27 |
Scoring of dermal reactions – individual data
Challenge treatment, escort group
Remazol-Brillianygelb GL FWTR 25% in isotonic saline (Day 15)
Treated area: left flank
Scoring of dermal reactions
|
Animal No.: |
16 |
17 |
18 |
19 |
20 |
48 hours p.a. |
Erythema Oedema Light yellow discoloured |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
|
Animal No.: |
16 |
17 |
18 |
19 |
20 |
72 hours p.a. |
Erythema Oedema Light yellow discoloured |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
Challenge treatment: Remazol-Brillianygelb GL FWTR 25% in isotonic saline (Day 22)
Treated area: left flank
Time of observation: 48 hours after treatment (Day 24)
Scoring of dermal reactions
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema Oedema Light yellow discol. |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema Oedema Light yellow discol. |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
Time of observation: 72 hours after treatment (Day 25)
Scoring of dermal reactions
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema Oedema Light yellow discol. |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema Oedema Light yellow discol. |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
0 0 X |
The skin of none of the treated animals (25%) showed a positive reaction during the observation period after the challenge.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.
Based on the results of this study Remazol-Brilliantgelb GL FWTR showed no evidence for sensitizing properties.
The substance is not classifiable according to CLP criteria. - Executive summary:
Testing for sensitizing properties of Remazol-Brilliantgelb GL FWTR was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5.0% Remazol-Brilliantgelb GL FWTR in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Brilliantgelb GL FWTR in isotonic saline.
Based on the results of this study there is no evidence for sensitizing properties of Remazol-Brilliantgelb GL FWTR.
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