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EC number: 220-491-7 | CAS number: 2783-94-0
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The objective of this acute oral toxicity study was to assess the toxicological profile of the test item when administered to rats by a single oral gavage.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- EC Number:
- 220-491-7
- EC Name:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 2783-94-0
- Molecular formula:
- C16H12N2O7S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- - Name of test material: disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate
- Molecular formula: C16H12N2O7S2.2Na
- Molecular weight: 454.38
- Substance type: organic
- Physical state: solid
-Purity : 91%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Vivo Bio Tech Ltd. Telangana
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 to 10 Weeks
- Weight at study initiation: 159.10 g to 169.08 g
- Fasting period before study: Rats were fasted overnight
- Identification:By rat accession number. Identification of individual rats was by cage card and turmeric colour body markings. The rat accession number was allotted during the course of the study. The temporary body marking during acclimatization period was done with crystal violet.
- Housing:Rats were housed individually in standard polysulfone cages
(Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage once a week
- Diet (e.g. ad libitum): Rat & Mice pellet feed, manufactured by Krishna Valley Agro Tech LLP, MIDC Kupwad block, Sangli, Maharashtra, was provided to animals
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes
- Acclimation period:After physical examination for good health and suitability for experiment, the animals were acclimatized five days for G1-FTS and ten days for G1-STS before treatment. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 59 to 67%,
- Air changes (per hr): air conditioned with adequate fresh air supply (12.4 air changes/hour)
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
IN-LIFE DATES: From:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Concentration in vehicle:2000 mg/kg
- Doses:
- G1(FTS) -2000 mg/kg
G1(STS) - 2000 mg/kg
G2(FTS) - 2000 mg/kg - No. of animals per sex per dose:
- G1(FTS) - 2000 mg/kg - 3
G1(STS) - 2000mg/kg - 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and pre-terminal deaths: Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and all observed clinical signs were recorded.
Body weights: The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
Gross Pathology: The rats surviving to the end of the observation period were euthanised by using isoflurane anaesthesia and subjected to detailed necropsy. Gross pathological findings were recorded and reported. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: not other details available
- Mortality:
- G1(FTS) - 2000 mg/kg - No pre-terminal deaths were observed
G1(STS) - 2000 mg/kg - No pre-terminal deaths were observed - Clinical signs:
- other: No changes observed
- Gross pathology:
- There were no gross pathological changes at necropsy.
- Other findings:
- not specified
Any other information on results incl. tables
TABLE 1. Body weight, body weight change and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
Day of Death (Time of Death) |
No. dead/ No. tested |
Pre-terminal deaths (%) |
|||||
Initial (Day 1) |
8thday |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
At Death |
||||||
G1 (FTS) 2000
|
Rm8767 |
F |
169.08 |
190.09 |
21.01 |
201.69 |
32.61 |
NA |
NA |
0/3
|
0 |
Rm8768 |
F |
162.00 |
181.86 |
19.86 |
193.26 |
31.26 |
NA |
NA |
|||
Rm8769 |
F |
159.10 |
173.41 |
14.31 |
185.02 |
25.92 |
NA |
NA |
|||
G1 (STS) 2000
|
Rm8770 |
F |
163.59 |
182.31 |
18.72 |
195.91 |
32.32 |
NA |
NA |
0/3
|
0 |
Rm8771 |
F |
159.85 |
177.63 |
17.78 |
182.51 |
22.66 |
NA |
NA |
|||
Rm8772 |
F |
160.86 |
185.03 |
24.17 |
187.15 |
26.29 |
NA |
NA |
F: Female FTS: First Treatment Step STS: Second Treatment Step NA: Not Applicable
APPENDIX 1. Individual clinical signs, dose administration and necropsy findings
|
F: Female FTS: First treatment step N: Normal min: minutes mg: milligrams kg: kilograms
mL: millilitre 055 (b): Recumbent; 043 (1): Ataxia – slight; NAD: No Abnormality Detected
APPENDIX 2 contd. Individual clinical signs, dose administration and necropsy findings
Group and Dose (mg/kg body weight) |
Date and time of administration |
Rat No. |
Sex |
Body weight (Day 1) (g) |
Total volume administered (mL) |
Day of observation |
||||
Day 1 |
||||||||||
30 min |
1hour |
2 hours |
3 hours |
4 hours |
||||||
G1 (STS) 300
|
13 April 2018 and 11:30 AM to 11:33 AM |
Rm8898 |
F |
209.31 |
0.06 |
N |
N |
N |
N |
N |
Rm8899 |
F |
214.86 |
0.06 |
N |
N |
N |
N |
N |
||
Rm8900 |
F |
193.13 |
0.06 |
043 (1) |
043 (1) |
043 (1) |
043 (1) |
N |
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Day of observation |
Necropsy Findings |
||||||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||||
G1 (FTS) 2000
|
Rm8767 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm8768 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
||
Rm8769 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female FTS: First treatment step N: Normal min: minutes mg: milligrams kg: kilograms
mL: millilitre NAD: No Abnormality Detected 161(14): Faecal colour- yellowish to orange
APPENDIX 2 contd. Individual clinical signs, dose administration and necropsy findings
Group and Dose (mg/kg body weight) |
Date and time of administration |
Rat No. |
Sex |
Body weight (Day 1) (g) |
Total volume administered (mL) |
Day of observation |
||||
Day 1 |
||||||||||
30 min |
1hour |
2 hours |
3 hours |
4 hours |
||||||
G1 (STS) 2000
|
10 April 2018 and 10:34 AM to 10:39 AM |
Rm8770 |
F |
163.59 |
1.6 |
N |
N |
N |
N |
N |
Rm8771 |
F |
159.85 |
1.6 |
N |
N |
N |
N |
N |
||
Rm8772 |
F |
160.86 |
1.6 |
N |
N |
N |
N |
N |
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Day of observation |
Necropsy Findings |
||||||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
|||||
G1 (STS) 2000
|
Rm8770 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm8771 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
||
Rm8772 |
F |
N 161(14 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female STS: Second treatment step N: Normal min: minutes mg: milligrams kg: kilograms
mL: millilitre NAD: No Abnormality Detected 161(14): Faecal colour- yellowish to orange
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the condition of the study, the acute oral LD50 (Cut-off value) of Neelicol Sunset Yellow FCF (CAS No. 2783-94-0) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Neelicol Sunset Yellow FCF (CAS No. 2783-94-0), when administered via oral route in Wistar rats.
- Executive summary:
The acute oral toxicity study withNeelicol Sunset YellowFCF[KZ1] in Wistar rats was conducted to assess the toxicological profile of the chemical Neelicol Sunset Yellow FCF(CAS No.2783 -94 -0). The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 19 hours) three female rats (G1-FTS) at the dose of 2000 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths. Hence, a confirmatory test was done at 2000 mg/kg body weight (G1-STS) with three additional female rats as per Annex 2d of the guideline OECD 423. There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, further dosing was stopped.The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.Based on the results of the present study, the test item,
Neelicol Sunset Yellow FCF, the LD50is >2000-5000 mg/kg body weight or Unclassified as per LD50cut-off value.
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