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Reaction mass of isomers disodium 8-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-5-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, disodium 5-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-8-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
EC number: 700-946-0 | 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:
- May 2013-June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- tetrasodium 5-[(1E)-2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl]-8-[(1E)-2-{2,5-dimethyl-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate 8-[(1E)-2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl]-5-[(1E)-2-{2,5-dimethyl-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
- EC Number:
- 700-946-0
- Molecular formula:
- C40H35N7Na2O6S2
- IUPAC Name:
- tetrasodium 5-[(1E)-2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl]-8-[(1E)-2-{2,5-dimethyl-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate 8-[(1E)-2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl]-5-[(1E)-2-{2,5-dimethyl-4-[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female
The female animals were non-pregnant and nulliparous.
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 - 9 weeks old, females: 8 - 9 weeks old
Body weight on the day of administration: males: 226 – 242 g; females: 208 – 213 g.
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Housing and Feeding 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. 0902)
- 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
Preparation of the Animals
The animals were marked for individual identification by tail painting.
Approximately 25 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.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- 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:
- Number of animals: 5 male and 5 female
- Control animals:
- no
- Details on study design:
- Preparation of the Animals
The animals were marked for individual identification by tail painting.
Approximately 25 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.
Dose Level
The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
Exposure Period
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.
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
A careful clinical examination was made several times on the day of dosing (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 animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial;
lot no. 228112; expiry date: 30/11/2015) at the dosage of approximately 8 mL/kg bw.
All animals were subjected to gross necropsy. All gross pathological changes were recorded.
Results and discussion
- Preliminary study:
- The test item showed signs of acute dermal toxicity and signs of dermal irritation after a single dose application in one female only.
A slight weight loss was recorded for 4 out of 5 female 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.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: Abnormal breathing on day 8 and slight piloerection on some occasions were observed in 1 of 5 female animals.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
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 |
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 |
0 min, 30 min, 1 h, 2 h, 3 h, 4 h |
no signs of toxicity |
day 2 |
slight piloerection |
|
day 3 to day 7 |
no signs of toxicity |
|
day 8 |
slight piloerection; slightly abnormal breething |
|
day 9 to day 13 |
slight piloerection |
|
day 14 until the end of the observation period |
no signs of toxicity |
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 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 3 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 4 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 5 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 6 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 7 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 8 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 9 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 10 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 11 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 12 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 13 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
Comments: E = erythema; O = oedema; * = residue of test item (black) nsf =no specific findings
|
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 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 3 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day 4 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
*, s |
0/0 |
* |
day 5 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
*, s |
0/0 |
* |
day 6 |
0/0 |
* |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 7 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 8 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 9 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 10 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 11 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 12 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
s |
0/0 |
nsf |
day 13 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 14 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
day 15 |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
0/0 |
nsf |
E = erythema; O = oedema; * = residue of test item (black); s = scratches nsf =no specific findings
|
Absolute Body Weights in g and Body Weight Gain in %
Dose: 2000 mg/kg body weight |
||||
Animal No. / Sex |
g |
g |
g |
% |
21 / male |
238 |
251 |
280 |
17.6 |
22 / male |
235 |
249 |
280 |
19.1 |
23 / male |
242 |
252 |
284 |
17.4 |
24 / male |
226 |
239 |
269 |
19.0 |
25 / male |
240 |
254 |
285 |
18.8 |
26 / female |
208 |
210 |
221 |
6.3 |
27 / female |
209 |
203 |
208 |
-0.5 |
28 / female |
209 |
202 |
204 |
-2.4 |
29 / female |
210 |
207 |
215 |
2.4 |
30 / female |
213 |
203 |
213 |
0 |
Macroscopic Findings - Individual Data – Males and Females
Dose: 2000 mg/kg bw |
||
Animal No. / |
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 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful or toxic according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item Acid Black RN 3333 to rats at a dose of 2000 mg/kg body weight was associated with no mortality but signs of toxicity in females which had a slight weight loss during the first week. Abnormal breathing on day 8 and slight piloerection on some occasions were seen in one female. There were no signs of dermal irritation with the exception of one female.
The dermal LD50 was determined to be > 2000 mg Acid Black RN 3333 / kg body weight. - Executive summary:
Acid black RN 3333 at single dose of 2000 mg/kg was applied over an area which was approximately 10% of the total body surface on the dorsal area (fur was removed) of five males and five females WISTAR Crl: WI(Han) rats and held in contact with the skin by a dressing throughout 24-hour period. The vehicle used for moistening was aqua ad injectionem. At the end of the treatment period the test item was removed using aqua ad injectionem and all the animals were observed for 14 days after application. No mortality occurred during the course of the study. For male animals no body weight loss was recorded while for the females some slight body weight loss was observed in two of them and scratches were observed in one female starting on day 4 until day 12 post application. Another female was noted to have slight piloerection on some occasions and abnormal breathing on day 8 post application. No other clinical signs were noted. At necropdy no macroscopic findings were observed.
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): aqua ad injectonem (sterile water)
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402
EC 440/2008, Method B.3
OPPTS 870.1200Results per Step
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:
Abnormal breathing on day 8 and slight piloerection on some occasions were observed in 1 of 5 female animals.
Effect on organs (related to dose level):
No treatment-related effects were observed.
Signs of irritation:
No erythema or oedema was observed. Scratches were observed in 1 of 5 female animals.
All signs of irritation were reversible within the observation period.
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