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EC number: 280-426-3 | CAS number: 83400-11-7
- 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:
- 1989-01-17 to 1989-08-02
- 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:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- EC Number:
- 280-426-3
- EC Name:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- Cas Number:
- 83400-11-7
- Molecular formula:
- C32 H21 Cl F2 N6 O11 S3 . x Li . x Na C32H(21-x-y)ClF2Li(x)N6Na(y)O11S3
- IUPAC Name:
- 4-(benzoylamino)-6-[[5-[[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]methyl]-1-sulpho-2-naphthyl]azo]-5-hydroxynaphthalene-1,7-disulphonic acid, lithium sodium salt
- Test material form:
- solid: particulate/powder
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
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: Mean: 328 g (from 271 to 369 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): Altromin 3022, 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 (%): 25
- 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:
- 1% in physiological saline
- Day(s)/duration:
- single application
- Adequacy of induction:
- other: based on the results from 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:
- not specified
- 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 recieved 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): 1% suspension of the test material formulated in physiological saline
Injection 3 (caudal): 1% 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% 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 aluminium 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 physioloigical saline), were applied to the left flank of all animals (test and first control group) and fixed for 24 h using a Fermoflex tape (Transatlantic GmbH, Schwarzenbach).
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 physioloigical saline) were applied to the left flank and fixed using a Fermoflex tape. 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 have 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):
- no
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:
- 20
- Total no. in group:
- 20
- Clinical observations:
- all animals showed erythema, 4 animals showed skin encrustation
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- all animals showed erythema, 10 animals showed skin encrustation
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: first control group
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- all animals showed erythema
- Remarks on result:
- other: not possible to differentiate between erythema and skin colouring caused by the test item
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: first control group
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- all animals showed erythema, one animals showed encrustation of the skin
- Remarks on result:
- other: not possible to differentiate between erythema and skin colouring caused by the test item
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- six animals showed erythema, 3 animals showed encrustation of the skin
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- three animals showed erythema, 4 animals showed encrustation of the skin
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: Second control group
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- other: Second control group
- Dose level:
- 12%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 5 animals showed erythema, two animals showed encrustation of the skin
- 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:
- three animals showed erythema, 5 animals showed encrustation of the skin
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: second control group
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- other: second control group
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs observed
- 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 was reddened at injected concentrations of 1% and 5%. It was not clear, whether the red colour derived from the test item or an inflammatory hyperemia caused this redness.
After 48 hours, encrustations occured at 2.5% (slight) and 5% (moderate).
- 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 |
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 | 2 | 2 |
2 | 2 | 1 |
3 | 2 | 2 |
4 | 2 | 1 |
5 | 2 | 2 |
6 | 2 | 2 |
7 | 1 | 1 |
8 | 2 | 1 |
9 | 2 | 2 |
10 | 2 | 1* |
Test group | ||
21 | 1 | 1 |
22 | 2 | 2 |
23 | 2* | 2* |
24 | 2* | 1* |
25 | 2 | 1 |
26 | 2 | 1 |
27 | 2 | 1** |
28 | 2 | 1** |
29 | 2 | 1 |
30 | 2 | 2 |
31 | 2 | 1* |
32 | 2* | *** |
33 | 1 | 1 |
34 | 2 | 1* |
35 | 2 | 1* |
36 | 2 | 1 |
37 | 2* | *** |
38 | 1 | 1 |
39 | 2 | 1** |
40 | 1 | 1 |
* = Application side partly encrusted
** = Application side partly scaly
*** = Encrusted application side, which was reddened on the previous day
**** = Encrustation on the whole depilated surface
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 | ||||
11 | 0 | 0 | 0 | 0 |
12 | 0 | 0 | 0 | 0 |
13 | 0 | 0 | 0 | 0 |
14 | 0 | 0 | 0 | 0 |
15 | 0 | 0 | 0 | 0 |
16 | 0 | 0 | 0 | 0 |
17 | 0 | 0 | 0 | 0 |
18 | 0 | 0 | 0 | 0 |
19 | 0 | 0 | 0 | 0 |
20 | 0 | 0 | 0 | 0 |
Test group | ||||
21 | 0 | 0 | 0 | 0 |
22 | 0 | 0 | 0 | 0 |
23 | 0 | 0 | 0 | 0 |
24 | 3* | 2* | 1 | 1* |
25 | 0 | 0 | 0 | 0 |
26 | 0 | 0 | 0 | 0 |
27 | 1 | 1* | 1 | 1* |
28 | 0 | 0 | 0 | 0 |
29 | 0 | 0 | 0 | 0 |
30 | 0 | 0 | 0 | 0 |
31 | 0**** | 0**** | 0**** | 0**** |
32 | 1* | 1* | 1* | 0* |
33 | 0 | 0 | 0 | 0 |
34 | 0 | 0 | 0 | 0 |
35 | 1 | 0**** | 1 | 0**** |
36 | 0 | 0 | 0 | 0 |
37 | 1 | 0 | 0 | 0 |
38 | 0 | 0 | 0 | 0 |
39 | 1 | 0 | 1 | 1 |
40 | 0 | 0 | 0 | 0 |
* = Application side partly encrusted
** = Application side partly scaly
*** = Encrusted application side, which was reddened on the previous day
**** = Encrustation on the whole depilated surface
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 male 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 1% 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 both groups, control and treatment group, showed erythema at the application site. Moreover, in the treatment groups an increased incidence of encrustations of the skin were observed.
During a second challenge the animals were treated with either 12% or 2.5% suspensions in physiological saline. During the re-challenge, erythema was 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.
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