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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
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- Auto flammability
- Flammability
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity:oral route:
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.
Acute toxicity:Dermal Route:
It was concluded that the acute dermal median lethal dose (LD50) of NEELICOL SUNSET YELLOW FCF (CAS No. 2783-94-0), when administered to female Wistar rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical NEELICOL SUNSET YELLOW FCF (CAS No. 2783-94-0) does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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.
- 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
- 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: - 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
- Preliminary study:
- not specified
- 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The data is K1 level as the study has been performed.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of this acute dermal toxicity study was to assess the toxicological profile of the test item on application as a single semi-occlusive dermal application to rats.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- 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 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsolateral thoracic surface of the skin
- % coverage: 10% of the body surface of the rat
- Type of wrap if used: The applied area was covered with cotton gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the applied area was washed with deionized water and wiped dry using clean towel.
- Time after start of exposure:24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The undiluted test item at the doses of 200 (0.20 mL/kg body weight), 1000 (1 mL/kg body weight) and 2000 (1.99 mL/kg body weight) was applied - Duration of exposure:
- 24 hours
- Doses:
- DRF G1 - 2000 mg/kg
Main G2- 2000 mg/kg - No. of animals per sex per dose:
- 3 [ 1 female/group for dose range finding study and 2 female / main study group (1 for dose range finding study and 2 for main study)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs and pre-terminal deaths (mortality) once during first 30 minutes after application, and at hourly intervals for 6 hours after application on the day of treatment (day 1) and once daily during Days 2 to 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical examination and pre-terminal deaths: All rats were observed for 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 observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body weights: Individual body weights of animals were recorded on test days 1 (Pre-application), 8 (7 days post application), and 15 (14 days post application).
Gross Pathology: At the end of the observation period, all rats were euthanised and exsanguinated under isoflurane anesthesia and subjected to detailed necropsy by an experienced prosector and the findings were recorded. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specifiedx`
- Preliminary study:
- Dose range finding study - Selection of dose level: An initial starting dose of 200 mg/kg body weight was tested with 1 female rat (dose range finding study). As there was no mortality at this dose range finding study the dose range finding study was continued with 1 female rat (dose range finding study) at the dose of 1000 mg/kg body weight. There was no mortality, hence the dose range finding study was continued with 1 female rat (dose range finding study) at the dose of 2000 mg/kg body weight.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- There were no pre-terminal deaths (mortality) observed during the study.
- Clinical signs:
- other: There were no clinical signs observed during the study.
- Gross pathology:
- No abnormality was detected at necropsy.
- Other findings:
- not specified
- Interpretation of results:
- other: Not classified
- Conclusions:
- It was concluded that the acute dermal median lethal dose (LD50) of NEELICOL SUNSET YELLOW FCF (CAS No. 2783-94-0), when administered to female Wistar rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical NEELICOL SUNSET YELLOW FCF (CAS No. 2783-94-0) does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.
- Executive summary:
The acute dermal toxicity of Neelicol Sunset Yellow FCF was tested with 2000 mg/kg with 1 female for the dose range finding study, followed by additional 2 females for main study at the dose of 2000 mg/kg body weight in Wistar rats.Based on the individual body weight, the test item at the dose of 2000 mg/kg body weight was weighed on an aluminum foil and made as a paste in Milli-Q water and applied directly to the clipped skin (Clipping was done approximately 24 hour prior to treatment) of the animal to cover about 10% of the body surface of the animal (semi-occlusive). The area of application was covered with cotton gauze (size: Females: 8 x 5 cm of 6 ply) and it was secured in position by adhesive tape wrapped around the torso. The test item contact period with the skin was for 24 hours.After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels. All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria. There were no clinical signs of toxicity and mortality. There was no skin reaction observed at test item applied area. Body weight was measured on days 1, 8 and 15 and all rats gained weight during experimental period. At the end of observation period, all surviving animals were euthanized and subjected to necropsy. There were no abnormalities detected at the necropsy.Based on the present study results, the acute dermal LD50of Neelicol Sunset YellowFCF is more than 2000 mg/kg body weight in female Wistar rats.
Reference
TABLE 1. Individual body weight, body weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
Pre-terminal deaths |
||||
Initial (Day 1 - at treatment) |
8th day |
Weight change (day 8 – Initial) |
15th day |
Weight change (day 15 – Initial) |
||||
G1 and 2000 DRF |
Rm8779 |
F |
229.80 |
244.45 |
14.65 |
232.63 |
2.83 |
0 |
G1 and 2000 Main study |
Rm8780 |
F |
237.85 |
239.22 |
1.37 |
248.70 |
10.85 |
0 |
Rm8781 |
F |
240.16 |
242.81 |
2.65 |
249.49 |
9.33 |
0 |
DRF: Dose Range Finding F: Female
APPENDIX 2. contd. Individual test item application, clinical signs, skin reaction and necropsy findings
Dose range finding study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G1 and 2000 DRF
|
05 April 2018 and 10.27 AM |
Rm8779 |
F |
229.80 |
460 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
S e x |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 2000 DRF |
Rm8779 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
APPENDIX 2 contd. Individual test item application, clinical signs, skin reaction and necropsy findings
main study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
S e x |
Initial Bwt (g) |
Quantity (mg) applied |
Observations and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1 h |
2 h |
3 h |
4 h |
5 h |
6 h |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
* |
Er @ |
Ed @ |
|||||||
G1 and 2000 Limit test Main
|
10 April 2018 and 10.14AM and 10.15 AM |
Rm8780 |
F |
237.85 |
476 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Rm8781 |
F |
240.16 |
480 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Rat Number |
S e x |
Observations |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G2 and 2000 Limit test Main
|
Rm8780 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm8781 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female N: Normal h: hour min: minutes NAD: No abnormality detected Er: Erythema Ed: Edema
Score 0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute toxicity: oral
No. of studies were reviewed for acute oral toxicity with Klimish rating 1,and 2 and 4 for the target substance for CAS: 2783-94-0.
The results for target are summarized as follows:
Sr.No |
Endpoint |
Effect values |
Species |
Sources |
1. |
LD50 |
>2000 mg/kg bw |
Rat(wistar) |
Data from k1 study report |
2. |
LD50 |
>6000 mg/kg bw |
Mouse (ICI Alderley Park |
Data from publication for target CAS: 2783-94-0 |
3. |
LD50 |
10000 mg/kg bw |
Rat (Carworth Farm E strain) |
Data from publication for target CAS: 2783-94-0 |
4. | LD50 |
>2000 mg/kg bw |
Rat (Wistar) |
Data from publication for target CAS: 2783-94-0 |
Based on the studies summarized in the above table for target substance Sunset Yellow FCF the endpoint value was found to vary between LD50 =>2000 mg/kg bw to 10000 mg/kg bw thus it is concluded that Sunset Yellow FCF does not exhibits acute toxicity by the oral route within the mentioned dose level.
Acute toxicity:inhalation
For disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.000000000133Pa at 25 degC as well as the particle size distribution indicates that the majority particle size is 250 (61.1%)micro meter. Thus, exposure by inhalation route is also unlikely for disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate given the comparatively larger size of the particulates.
Acute toxicity:dermal
The acute dermal toxicity of Neelicol Sunset Yellow FCF was tested with 2000 mg/kg with 1 female for the dose range finding study, followed by additional 2 females for main study at the dose of 2000 mg/kg body weight in Wistar rats.Based on the individual body weight, the test item at the dose of 2000 mg/kg body weight was weighed on an aluminum foil and made as a paste in Milli-Q water and applied directly to the clipped skin (Clipping was done approximately 24 hour prior to treatment) of the animal to cover about 10% of the body surface of the animal (semi-occlusive). The area of application was covered with cotton gauze (size: Females: 8 x 5 cm of 6 ply) and it was secured in position by adhesive tape wrapped around the torso. The test item contact period with the skin was for 24 hours.After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels. All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria. There were no clinical signs of toxicity and mortality. There was no skin reaction observed at test item applied area. Body weight was measured on days 1, 8 and 15 and all rats gained weight during experimental period. At the end of observation period, all surviving animals were euthanized and subjected to necropsy. There were no abnormalities detected at the necropsy.Based on the present study results, the acute dermal LD50ofNeelicol Sunset YellowFCFis more than 2000 mg/kg body weight in female Wistar rats.
In a supporting study of Read across substance, The acute dermal median lethal dose (LD50) ofdisodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC)in rabbit was found to be >10000 mg/kg of body weight. Acute toxicity ofdisodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl) azo]naphthalene-2-sulphonate (ALLURA RED AC)to rabbit by dermal route indicates that disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl) azo]naphthalene-2-sulphonate (ALLURA RED AC) does not exhibits acute toxicity by the dermal route within the doses mentioned in the study.
Justification for selection of acute toxicity – oral endpoint
Acute toxicity by oral route for Sunset Yellow FCF was examined on groups of five male and female ICI Alderley Park Strain mice. LD50 value was calculated by Weil which found to be greater than 6000 mg/kg bw. This value indicates that the Sunset Yellow FCF does not exhibit acute toxicity by oral
route.
Justification for selection of acute toxicity – inhalation endpoint
For disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.000000000133Pa at 25 degC as well as the particle size distribution indicates that the majority particle size is 250 (61.1%)micro meter. Thus, exposure by inhalation route is also unlikely for disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate given the comparatively larger size of the particulates.
Justification for selection of acute toxicity – dermal endpoint
Acute dermal toxicity is unlikely to occur since dermal absorption of disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate is very low based on the value 0.00011 mg/cm2/event. Also considering the use of the chemical as a food additive, and considering the volatility absorption by the dermal route is not considered to be significant. Thus, given the above considerations, it is assumed that disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate shall not exhibit acute dose toxicity by the dermal route.
Justification for classification or non-classification
Based upon the study results and available information, the substance Sunset Yellow FCF is not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.
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