Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- September 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-) and hydrogen[N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction mass of disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-) and hydrogen[N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy premises
- Weight at study initiation: from 160 to 180 grams
- Fasting period before study: animals fasted overnight
- Housing: housed in group of 5 in Macrolon cages (type3)
- Diet (e.g. ad libitum): ad libitum NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 2% CMC - Doses:
- 3170, 4640, 6000, 7750 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: physical condition - Statistics:
- LD50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- ca. 3 170 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 7 993 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 6 335 - ca. 10 085
- Mortality:
- Mortality observed for concentrations above 3170 mg/kg body weight. See Table 1 for overall results.
- Clinical signs:
- other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur.
- Gross pathology:
- No substance related gross organ changes were seen.
Any other information on results incl. tables
Rate of deaths
Dose mg/kg |
Concentration % of formulation |
N° of animals (M, male F, female) |
Died within |
||||||||||
1 hour |
24 hours |
48 hours |
7 days |
14 days |
|||||||||
|
|
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
M |
F |
3170 |
30 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4640 |
50 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
6000 |
50 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
2 |
0 |
2 |
7750 |
50 |
5 |
5 |
0 |
0 |
1 |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
10000 |
50 |
5 |
5 |
0 |
0 |
0 |
4 |
1 |
5 |
1 |
5 |
1 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The acute oral LD50 of substance in rats of both sexes observed over a period of 14 days is 7993 (6335-10085) mg/kg.
LD50 = 5834.9 mg/kg bw based on active ingredient. - Executive summary:
Method
The test substance was tested for acute toxicity for oral route following a procedure similar to OECD 401.
The rats were kept at a room temperature of 22 ± 1 °C, at a relative humidity of 55 ± 5 % and on a 10 hours light cycle day. They received ad libitum rat food and water. Prior to treatment the animals were adapted for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.
During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3).
Physical condition and rate of deaths were monitored throughout the whole observation period.
The substance was administered by oral intubation at the following concentrations: 3170, 4640, 6000, 7750 and 10000 mg/kg body weight. 5 rats per sex per dose were exposed at each concentration. Dyspnoea, exophtalmus, ruffled fur, curved body position and a transient diarrehea were seen.
Results
The LD50 observed in rats was 5834.9 mg/kg bw.
The animals were submitted to a necropsy whenever they died, survivors at the end of the observation period.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.