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EC number: 700-936-6 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-24 to 2013-09-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- tetrasodium 4-[(E)-2-[2-(carbamoylamino)-4-[(2,6-difluoropyrimidin-4-yl)amino]phenyl]diazen-1-yl]benzene-1,3-disulfonate 4-[(E)-2-[2-(carbamoylamino)-4-[(4,6-difluoropyrimidin-2-yl)amino]phenyl]diazen-1-yl]benzene-1,3-disulfonate
- EC Number:
- 700-936-6
- Molecular formula:
- C17H11F2N7Na2O7S2
- IUPAC Name:
- tetrasodium 4-[(E)-2-[2-(carbamoylamino)-4-[(2,6-difluoropyrimidin-4-yl)amino]phenyl]diazen-1-yl]benzene-1,3-disulfonate 4-[(E)-2-[2-(carbamoylamino)-4-[(4,6-difluoropyrimidin-2-yl)amino]phenyl]diazen-1-yl]benzene-1,3-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1531)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 240113)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- AlleMan Pharma, lot no. 26210S1-2, expiry date: 09/2015
- Details on dermal exposure:
- Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper.
Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals.
Application:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing
and non-irritating tape and was fixed with an additional dressing in a suitable manner. - Duration of exposure:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item
was removed using aqua ad injectionem - Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- Observation period:
All animals were observed for 14 days after dosing
Weight Assessment:
The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
Clinical Examination:
careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention
given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for
clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally
(Narcoren®, Merial; lot no. 224052; expiry date: 05/2015) at the dosage of approximately 8 mL/kg bw. All animals were subjected to gross necropsy.
All gross pathological
changes were recorded and in case of findings the tissues were preserved for a possible histopathological evaluation. The preserved
tissues of which no histopathological evaluation was made will be discarded 3 months after the release of the final report unless otherwise
agreed upon with the sponsor.
Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results,
a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- No treatment-related effects were observed.
- Body weight:
- A slight weight loss was recorded for 1 out of 5female animals during the first week, but all of the female animals showed weight gain during
the second week. The effects on weight development might be secondary to the dressing, and toxicological relevance of this finding cannot
clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation. - Gross pathology:
- No treatment-related effects were observed.
- Other findings:
- Neither erythema nor oedema were observed in any animal throughout the observation period.
Eschar and scratches were observed in 1 of 5 male animals.
These signs of irritation were reversible within the observation period.
Test item residues observed in all tested animals were not assumed to be a sign of irritation.
Any other information on results incl. tables
Table Clinical Signs of Systemic Toxicity – Individual Data - Males:
Animal |
Time of |
Observations |
21/ male / |
during the whole observation period |
no signs of toxicity |
22/ male / |
during the whole observation period |
no signs of toxicity |
23/ male / |
during the whole observation period |
no signs of toxicity |
24/ male / |
during the whole observation period |
no signs of toxicity |
25/ male / |
during the whole observation period |
no signs of toxicity |
bw = body weight
Table Clinical Signs of Systemic Toxicity – Individual Data – Females:
Animal |
Time of |
Observations |
26/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
27/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
28/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
29/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
30/ female / 2000 mg/kg bw |
during the whole observation period |
no signs of toxicity |
bw = body weight
Table Skin Irritation – Individual Data – Males:
Day after Start of Application |
Animal No. 21 |
Animal No. 22 |
Animal No. 23 |
Animal No. 24 |
Animal No. 25 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 3 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 4 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 5 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 6 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 7 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 8 |
0/0 |
tir |
0/0 |
tir, s |
0/0 |
tir |
0/0 |
c |
0/0 |
tir |
day 9 |
0/0 |
tir |
0/0 |
tir, es |
0/0 |
tir |
0/0 |
c |
0/0 |
tir |
day 10 |
0/0 |
tir |
0/0 |
tir, es |
0/0 |
tir |
0/0 |
c |
0/0 |
tir |
day 11 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
c |
0/0 |
tir |
day 12 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
c |
0/0 |
tir |
day 13 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
day 14 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
day 15 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
Comments: E = erythema; O = oedema; 0, 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) tir = test item residues; s = scratches above and in the center of the application site; es = eschar above and in the center of the application site; reversibility: c = completely reversed |
Table Skin Irritation – Individual Data – Females:
Day after Start of Application |
Animal No. 26 |
Animal No. 27 |
Animal No. 28 |
Animal No. 29 |
Animal No. 30 |
|||||
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
E/O |
Comments |
|
day 2 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 3 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 4 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 5 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 6 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 7 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 8 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 9 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 10 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 11 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 12 |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
0/0 |
tir |
day 13 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
day 14 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
day 15 |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
0/0 |
c |
Comments: E = erythema; O = oedema; 0, 1, 2, 3, 4 = scoring system laid down in OECD Guideline 404 (Table 2) tir = test item residues; reversibility: c = completely reversed |
Table Absolute Body Weights in g and Body Weight Gain in %:
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g |
g |
g |
% |
21/male |
248 |
260 |
292 |
18 |
22/male |
249 |
271 |
307 |
13 |
23/male |
240 |
248 |
284 |
18 |
24/male |
238 |
253 |
290 |
22 |
25/male |
242 |
256 |
293 |
21 |
26/female |
215 |
215 |
220 |
2 |
27/female |
210 |
211 |
228 |
9 |
28/female |
216 |
208 |
216 |
0 |
29/female |
223 |
226 |
236 |
6 |
30/female |
208 |
209 |
219 |
5 |
Table Macroscopic Findings - Individual Data – Males and Females:
Dose: 2000 mg/kg bw |
||
Animal No. / Sex |
Organ |
Macroscopic Findings |
21/male |
- |
nsf |
22/male |
- |
nsf |
23/male |
- |
nsf |
24/male |
- |
nsf |
25/male |
- |
nsf |
26/female |
- |
nsf |
27/female |
- |
nsf |
28/female |
- |
nsf |
29/female |
- |
nsf |
30/female |
- |
nsf |
Table LD50:
Dose (Unit)
|
Number of Animals Investigated |
Number of Intercurrent Deaths |
LD50 |
2000 mg/kg bw |
5 males |
0 |
> 2000 mg/kg bw |
2000mg/kg bw |
5 females |
0 |
> 2000 mg/kg bw |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- other: LD 50 > 2000 mg/kg bw
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item Reactive Golden Yellow HF-RN 1331 to rats at a dose
of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity but slight signs of irritation in one out of ten
animals which were reversible within the observation period.
The dermal LD50 was determined to be > 2000 mg Reactive Golden Yellow HF-RN 1331 / kg body weight. - Executive summary:
- Summary Results
LD50: > 2000 mg /kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): aqua ad injectionem
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, Method B.3, OPPTS 870.1200
Table: Results
Sex
Dose
(mg/kg bw)Number
of AnimalsNumber
of Intercurrent Deathsmale
2000
5
0
female
2000
5
0
Signs of toxicity related to dose level used, time of onset and duration: No treatment-related effects were observed.
Effect on organs (related to dose level): No treatment-related effects were observed.
Signs of irritation: Neither erythema nor oedema were observed in any animal throughout the observation period. Eschar and scratches were observed in 1 of 5 male animals. These signs of irritation were reversible within the observation period. Test item residues observed in all tested animals were not assumed to be a sign of irritation.
Conclusion
Under the conditions of the present study, single dermal application of the test item Reactive Golden Yellow HF-RN 1331 to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity but slight signs of irritation in one out of ten animals which were reversible within the observation period.
The dermal LD50 was determined to be > 2000 mg Reactive Golden Yellow HF-RN 1331 / kg body weight.
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