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REACH

Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate

EC number: 220-491-7 | CAS number: 2783-94-0

Life Cycle description
Uses advised against

Toxicological information

Endpoint summary

Currently viewing:

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

Reference

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.

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

Reference

Endpoint:: acute toxicity: inhalation
Data waiving:: other justification
Justification for data waiving:: other:

Endpoint conclusion

Endpoint conclusion:: no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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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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.

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 (%)
Group and Dose (mg/kg body weight)	Rat No.	Sex	Initial (Day 1)	8^thday	Weight change (day 8 – Initial)	15^thday	Weight change (day 15 – Initial)	At Death	Day of Death (Time of Death)	No. dead/ No. tested	Pre-terminal deaths (%)
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

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)	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.	S e x	Body weight (g)					Pre-terminal deaths
Group and Dose (mg/kg body weight)	Rat No.	S e x	Initial (Day 1 - at treatment)	8^th day	Weight change (day 8 – Initial)	15^th day	Weight change (day 15 – Initial)	Pre-terminal deaths
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
G1 and 2000 Main study	Rm8781	F	240.16	242.81	2.65	249.49	9.33	0