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EC number: 265-529-3 | CAS number: 65151-26-0
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- limited documentation regarding composition of test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- EC Number:
- 265-529-3
- EC Name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- Cas Number:
- 65151-26-0
- Molecular formula:
- C17H15N3O7S2.2Na
- IUPAC Name:
- disodium 7-[(4-amino-3-methoxyphenyl)diazenyl]naphthalene-1,3-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD* (SD) IGS BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All animals were dosed once; the test substance was administered orally as a solution in distilled water
- Doses:
- 200 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Groups of fasted animals were treated as follows:
Dose Level(mg/kg bw) Number of Rats
2000 3 females
200 3 females
200 3 males - Control animals:
- no
- Details on study design:
- 2000 mg/kg was chosen as the starting dose.
All animals were dosed once only. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential.
The animals were observed for deaths and clinical signs 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual body weights were recorded prior to dosing and 7 and 14 days after treatment.
All animals were subjected to gross necropsy - Statistics:
- not necessary
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - <= 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: according to the conclusion of the author of the study report
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: as derived by the assessor of the study report
- Mortality:
- All animals treated with 2000 mg/kg bw were found death during the day of dosing. No deaths were noted at a dose level of 200 mg/kg bw.
- Clinical signs:
- other: signs of systemic toxicity noted in females were ataxia, lethargy, hunched posture, decreased respiratory rate, laboured respiration and dark orange staining of the feces and urine. No signs of systemic toxicity were noted in males treated with 200 mg/kg
- Gross pathology:
- For the 200 mg/kg bw dose group no abnormalities were noted at necropsy; for the 2000 mg/kg dose group see table 3 below
Any other information on results incl. tables
Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
200 |
2-0 Female |
0 |
0 |
0 |
FU |
HFU |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-1 Female |
0 |
0 |
0 |
FU |
HFU |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
FU |
HFU |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-1 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
H = Hunched posture
F = Dark orange stained feces
U = Dark orange stained urine
Table 2 Individual Body Weights and Body Weight Changes
Dose Level |
Animal Number |
Body Weight (g) at Day |
Body Weight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
200 |
2-0 Female |
211 |
234 |
256 |
23 |
22 |
2-1 Female |
229 |
252 |
256 |
23 |
4 |
|
2-2 Female |
218 |
249 |
270 |
31 |
21 |
|
3-0 Male |
246 |
319 |
374 |
73 |
55 |
|
3-1 Male |
253 |
321 |
371 |
68 |
50 |
|
3-2 Male |
231 |
296 |
351 |
65 |
55 |
Table 3 Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
4 hours after dosing |
lungs and gastric mucosa: haemorrhagic; liver and kidneys: dark; small and large intestine: red/orange liquid present |
1-1 Female |
4 hours after dosing |
lungs and gastric mucosa: haemorrhagic; liver and kidneys: dark; small and large intestine: red/orange liquid present |
|
1-2 Female |
4 hours after dosing |
lungs and gastric mucosa: haemorrhagic; liver and kidneys: dark; small and large intestine: red/orange liquid present |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Considering that all animals treated with 2000 mg/kg bw were found dead and that no deaths were noted at a dose level of 200 mg/kg bw. the acute oral median lethal dose (LD50) between 300 and 500 mg/kg body weight derived by the author of the report was inexplicable without further explanation. Thus the actual value was considered to be above 200 and below 2000 mg/kg bw.. Taking this into account and applying the CLP translation table (ANNEX VII, Table 1.1) a classification as Acute Tox. Cat 4, H302 was considered to be adequate.
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Sprague-Dawley rat.
Methods
A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of three fasted females and three males respectively at a dose level of 200 mg/kg bw. Dosing was performed sequentially.
The test item was administered orally as a solution in distilled water. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. All animals treated with 2000 mg/kg bw died.
Clinical Observations. Hunched posture and dark orange stained feces and urine were noted up to day 3 in females exclusively.
Body Weight. All animals of the 200 mg/kg dose group showed expected body weight gain.
Necropsy. No abnormalities were noted at necropsy in the 200 mg/kg bw dose group. In all animals of the 2000 mg/kg bw dose group haemorrhagic lungs and gastric mucosa, dark lung and kidneys and red/orange liquid present in small and large intestine were observed.
Conclusion by the author of the report
According to the results of the study the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be between 300 and 500 mg/kg bwt.
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