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EC number: 413-090-5 | 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:
- 03 May 1993 to 04 June 1993
- 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:
- 1993
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
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already available
Test material
- Reference substance name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- EC Number:
- 413-090-5
- Cas Number:
- 189574-45-6
- Molecular formula:
- Hill formula: C24H18LixN10NayO12S4
- IUPAC Name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See below
Constituent 1
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 = 335 g (= 100 %)
x min = 314 g (- 2.3 %)
x max = 348 g (+3.8 %)
n =15
Randomisation schemes: 411/92
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 % solution of test substance in istonic saline / 2 x 0.1 ml
5 % solution of test substance in 50% Freund's adjuvant / 2 x 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:
- 25 % test substance in isotonic saline / 0.5 mL
- Day(s)/duration:
- Day 8 / 48 h
- 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% / 0.5 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Group No. of animals
Determination of the primary non-irritant concentration 6
Determination of the tolerance of intradermal injection 3
Escort group 5
Control group 5
Treatment group 10 - Details on study design:
- 10 animals in the treatment group and 5 animals in the control group were used. Based on experience these animal numbers are sufficient for the determination of the sensitising properties of test substances.
In case of a questionable result additional animals will be tested to give a total of 20 test and 10 control animals.
Preparation of test concentrations
The following vehicles were used:
Freund's Complete Adjuvant (Behringwerke AG, Marburg)
isotonic saline (sterile, pyrogen-free; Fresenius AG, Bad Homburg)
Freund's Complete Adjuvant was mixed immediately before use with an equal volume of physiological saline. This 50 % adjuvant solution was administered to the animals by intradermal injection.
For the dermal treatments, Reaktiv-Gelb F-68 072 FW was applied in isotonic saline [percentages w/v]. For the intradermal injections, Reaktiv-Gelb F-68 072 FW was diluted with isotonic saline [percentages w/v].
For the intradermal injections of the test substance in 50 % Freund's adjuvant, Reaktiv-Gelb F-68 072 FW was diluted with isotonic saline and then mixed with an equal volume of Freund's Original Adjuvant [percentages w/v].
The concentrations for the maximisation test cannot be standardized. Suitable concentrations are established in preliminary tests. The selected concentration of the test substance depends on the individual phases of the study.
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 flanks 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 2x4 cm in the vicinity of the shoulder.
Main test for sensitizing 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 (see prior page). The injection sites were left uncovered.
Treated Group:
Site 1: 2 x 0.1 ml 50 % Freund's Adjuvant 2 x 0.1 ml
Site 2: 2 x 0.1 ml 5 % solution of test substance in istonic saline
Site 3: 2 x 0.1 ml 5% solution of test substance in 50% Freunds adjuvant
Control and escort groups:
Site 1: 2 x 0.1 ml 50% Freunds Adjuvant
Site 2: 2 x 0.1 ml isotonic saline
Site 3: 2 x 0.1 ml 50% 50% Freunds Adjuvant
Days 1-6
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 % Reaktiv-Gelb F-68 072 FW in isotonic saline.
Day 23
Occlusive bandage removed.
Day 24
Skin examined.
Day 25
Skin examined.
Body weights of test animals determined. - Challenge controls:
- patch with Physiological saline in treatment and control groups
- Positive control substance(s):
- yes
- Remarks:
- bi-annual testing
Results and discussion
- Positive control results:
- valid - the bi-annually conducted positive control showed sufficient skin sensitisation
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Challenge treatment: Reaktiv-Gelb F-68 072 FW 25% in isotonic salin
Treated area: left flank
Time of observation: 48 hours after treatment
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Skin discoloured orange |
X |
X |
X |
X |
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Skin discoloured orange |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Time of observation: 72 hours after treatment
Scoring of dermal reactions |
||||||||||
Control animals |
1 |
2 |
3 |
4 |
5 |
|
|
|
|
|
Erythema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Oedema |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
Skin discoloured orange |
X |
X |
X |
X |
X |
|
|
|
|
|
Treated animals |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Skin discoloured orange |
X |
X |
X |
X |
X |
X |
X |
X |
X |
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.
Thus, the percentage of animals reacting positive is below the threshold of 30%.
Based on the results of this study Reaktiv-Gelb F-68 072 FW showed no evidence for sensitising properties. - Executive summary:
Chemical substances may produce an immunological reaction (sensitisation) after single or repeated dermal application. Further application after the elapse of a certain period may cause allergic reactions. The objective of the test procedure described here is to determine the potential sensitizing properties of a substance.
This study was conducted in compliance with EC-Guideline B.6. Acute Toxicity Sensitization of the Skinof the Directive 92/69/EWG and OECD-Guideline for testing of chemicals, 406 "Skin Sensitization". This study was conducted in compliance with the Principles of Good Laboratory Practice(GLP).
Testing for sensitising properties of Reaktiv-Gelb F-68072FW was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 5% Reaktiv-Gelb F-68072FW in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Reaktiv-Gelb F-68072FW in isotonic saline.
Based on the results of this study Reaktiv-Gelb F-68 072 FW showed no evidence of sensitising properties. The substance does not trigger classification and labelling for sensitisation endpoint.
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