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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
Endpoint summary
Administrative data
Description of key information
The substance disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate does not exhibit repeated dose toxicity by the oral,inhalation and dermal route.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Principles of method if other than guideline:
- 80 weeks chronic repeated dose oral toxicity study of Sunset Yellow examination in Mice of the Charles River CD strain to evaluate adverse effects and their reversibility and the non observed- effect level.
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF breeding colony
- Weight at study initiation: Male- 21-30 g and female - 17-25 g
- Fasting period before study: no
- Housing: housed in cages of 15
- Diet (e.g. ad libitum): ground Oxoid pasteurized breeding diet; ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 1°C
- Humidity (%):50-60% - Route of administration:
- oral: feed
- Vehicle:
- other: basic diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Basic diets containing 2000, 4000,8000,16000 mg/l (0.2, 0.4, 0-8 or 1.6%) Sunset Yellow FCF
DIET PREPARATION
- Rate of preparation of diet (frequency): Daily
- Mixing appropriate amounts with (Type of food): ground Oxoid pasteurized breeding diet - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
2000,4000,8000,16000 mg/kg (0.2, 0.4, 0.8 or 1.6% respectively)
Basis:
nominal in diet - No. of animals per sex per dose:
- Control group:60 male and 60 females
Test group: 30 male and 30 females - Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Cage side observations: avoid further fighting all the mice were caged individually from month 8. Any mouse showing signs of ill health was isolated, to be returned to its cage.
BODY WEIGHT: Yes - Time schedule for examinations:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at wk 13, 26 and 52 and from all surviving mice at wk 80.
- Anaesthetic used for blood collection: No
- Animals fasted: No data
- How many animals: ten male and ten female mice
- Parameters checked: hemoglobin concentration, packed cell volume and counts, Differential leucocyte counts and reticulocyte counts.
ORGAN WEIGHT: Yes
-Brain, heart, liver, kidneys, spleen, stomach, small intestine, caecum and testes were weighed - Sacrifice and pathology:
- SACRIFICE : Mice killed by exsanguination from the aorta under barbiturate anaesthesia.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
All tissues from the control mice and those fed 1.6% Sunset Yellow FCF were examined microscopically, while at the lower dietary levels examination was confined to the liver and kidney together with any tissue seen to be abnormal at autopsy. - Other examinations:
- Behavior and were weighed at 4-wk intervals throughout the study.
During the first half of the study it was noticed that there was a tendency for the male mice to fight. Bite lesions of the anogenital region were particularly frequent and these were associated with obstructions of the urinary tract. To avoid further fighting, all the mice were caged individually from month 8. - Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No changes in body-weight gains.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No evidence of any haematological adverse effect due to the administration of Sunset Yellow FCF.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant differences between the organ weights or relative organ weights of the test groups and the corresponding controls.
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- NON-NEOPLASTIC- No differences between treated and control mice in the incidence or severity of the lesions seen.
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 16 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- The 80 weeks chronic repeated dose study on male and female Charles River CD mouse indicated that no effects observed on body weight, organ weight, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 16000 mg/kg diet. - Executive summary:
In order to determined the repeated oral toxicity ofSunset Yellow FCF, a 80weeks repeated dose toxicity study in Charles River CD mouse (male and female) was conducted at dose levels of 2000,4000,8000,16000 mg/kg (0.2, 0.4, 0.8 or 1.6% respectively) by oral diet route .
From experimental study effects observed as No changes in body-weight gains, no significant differences between the organ weights, no evidence of any adverse effect to hematological examinations, no differences between treated and control mice in the incidence or severity of the lesions seen at high dose level.
There were deaths in all groups during the study but there was no relationship between the number of deaths at any time and the dietary intake of Sunset Yellow FCF. Many of the male mice dying or killed during the first half of the study were those that had been fighting.
Thus, on the basis of above results the NOAEL (no observed adverse effect level) forSunset Yellow FCFwas considered to be 16000 mg/kg diet.
Reference
There were deaths in all groups during the study but there was no relationship between the number of deaths at any time and the dietary intake of Sunset Yellow FCF (Table 1). Many of the male mice dying or killed during the first half of the study were those that had been fighting.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 16 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- The data is K2 level as the data has been obtained from the experimental study from the reliable journal 'Food and Cosmetic toxicology'.
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Principles of method if other than guideline:
- The repeated dose toxicity study was conducted to evaluate the toxic effects of administration of Acid Orange 7 to rabbits by the dermal route for 90 days.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- open
- Vehicle:
- other: water as well as USP White Ointment
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- For abraded skin for 21 days
For intact skin for 90 days. - Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0,0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg)
Basis: - No. of animals per sex per dose:
- 0 mg/l = 3 animals
1000 mg/l =3 animals
10000 mg/l =3 animals - Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
HAEMATOLOGY: Yes
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- no effects observed
- Description (incidence and severity):
- no mortality was observed.
- Dermal irritation:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- no mortality was observed.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological values was normal
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- urinary components were normal
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Gross autopsies disclosed no dose-related findings.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 other: mg/kg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Effects: There was no mortality or any evidence of systemic toxicity. Haematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.
- Critical effects observed:
- not specified
- Conclusions:
- The 90 days subchronic repeated dose dermal study on rabbit indicated that no effects observed on mortality, urinalysis, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 10000 mg/kg. - Executive summary:
In order to determined the repeated dermal toxicity of Acid Orange 7, a 90 days repeated dose toxicity study in rabbits was conducted at dose levels of 0(control),0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg) by dermal route .
From experimental study there was no mortality or any evidence of systemic toxicity. Hematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.
Thus, on the basis of above results the NOAEL (no observed adverse effect level) for Acid Orange 7 considered to be 10000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- The data is K4 level as the data has been obtained from the experimental study from the study report of 'Toilet Goods Association'
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity oral:
Based on the various studies available with Klimish rating 2 and 4 for the target substance CAS: 2783-94-0.
The results for target are summarized as follows
Sr. No |
End point |
Value |
Species/strain |
Route |
Effects |
Remarks |
1. |
NOAEL |
16000 mg/kg diet |
Mouse (Charles River CD) |
oral: feed |
No changes in body-weight gains,no significant differences between the organ weights,no evidence of any adverse effect to haematological examinations,no differences between treated and control mice in the incidence or severity of the lesions seen. |
Data from publication’Food and Cosmetic toxicology’ for target CAS: 2783-94-0.
|
2. |
LOAEL |
15000 mg/kg diet |
Rat |
oral: feed |
Lowered white cell count,Decrease in liver weight and weight of the spleen in two of the groups,reduced food consumption. |
Data from study report ‘Department of National Health and Welfare’ for target CAS: 2783-94-0. |
3. |
NOAEL(female rat) |
6000 mg/kg diet |
Rat (Fischer 344) |
oral: feed |
No mortality was observed. |
Data from study report of ‘NTP’for target CAS: 2783-94-0. |
NOAEL(male rat) |
12000 mg/kg diet |
No deaths were observed. |
||||
LOAEL(female rat) |
12500 mg/kg diet |
decreases in mean body weight gain |
||||
LOAEL(male rat) |
25000 mg/kg diet |
Decreases in mean body weight gain |
||||
4. |
NOAEL |
<6000 and 50000 mg/kg diet |
Mouse (B6C3F1) |
oral: feed |
No gross or microscopic lesions were observed. |
|
5. |
LOAEL |
100000 mg/kg diet |
Mouse (B6C3F1) |
oral: feed |
Mean body weight gain among was depressed. |
Data from study report of ‘NTP’for target CAS: 2783-94-0. |
Based on the studies summarized in the above table with oral routes it can be observed that the endpoint lowest observed adversed effect (LOAEL) value varies between 12500 mg/kg diet to 100000 mg/kg diet mg/kg diet and no observed adversed effect level (NOAEL) value varies between 6000 mg/kg diet to 50000 mg/kg diet based on the data from publication and study report for target substance. The effect observed on the above doses are-
*Lowered white cell count, Decrease in liver weight and weight of the spleen in two of the groups, reduced food consumption.
*Decreases in mean body weight gain.
*Mean body weight gain among was depressed.
During experiment no effects observed for following parameters-
* No changes in body-weight gains, no significant differences between the organ weights, no evidence of any adverse effect to hematological examinations, no differences between treated and control mice in the incidence or severity of the lesions seen.
*No mortality was observed.
Based on the above results it can be concluded that the lowest observed adversed effect (LOAEL) is 12500 mg/kg diet , thus based on this value it can be concluded that substance CAS: 2783-94-0 (Sunset Yellow FCF) is considered to be not toxic to repeated dose via oral route below the dose level of 12500 mg/kg diet.
Repeated dose toxicity (Inhalation)
For disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate, repeated dose 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.
Repeated dose toxicity (Dermal)
Based on the studies available with Klimish rating 4 for the read across substances of target CAS: 2783-94-0.
The results for read across substances are summarized as follows
Sr. No |
End point |
Value |
Species/strain |
Route |
Effects |
Remarks |
1. |
NOAEL |
10000 mg/kg |
Rabbit |
Dermal |
There was no mortality or any evidence of systemic toxicity. Haematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings. |
Experimental data from study report of”Toilet Goods Association”for read across CAS:633-69-5 |
2. |
NOAEL |
50000 mg/kg |
Mouse |
Dermal |
No dye-related anomalies were noted in terms of survival, or gross and histopathology of major organs and the skin. |
Experimental data from study report of”5Hazelton Laboratories”for read across CAS:25956-17-6 |
Based on the studies summarized in the above table with dermal routes it can be observed that the endpoint no observed adversed effect level (NOAEL) value varies between 10000 mg/kg to 50000 mg/kg based on the data from study report for read across substance. No effects was observed on the above doses as-
* There was no mortality or any evidence of systemic toxicity. Haematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.
* No dye-related anomalies were noted in terms of survival, or gross and histopathology of major organs and the skin.
In the absence of repeated dose toxicity by dermal route data for Sunset Yellow FCF, data from two read-across chemicals have been used. Since it is expected to show the similar toxicological effect based on the effects observed on the other category members. Thus from above results the no observed adversed effect (NOAEL) is 10000 mg/kg concluded that substance CAS: 2783-94-0 (Sunset Yellow FCF) is considered to be not toxic to repeated dose via dermal route below the dose level of 10000 mg/kg.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The 80 weeks chronic repeated dose study on male and female Charles River CD mouse indicated that no effects observed on body weight, organ weight, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 16000 mg/kg diet.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
For disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate, repeated dose 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 repeated dose toxicity dermal - systemic effects endpoint:
The 90 days subchronic repeated dose dermal study on rabbit indicated that no effects observed on mortality, urinalysis, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 10000 mg/l.
Justification for classification or non-classification
The substance do not show repeated dose toxicity effect for oral,inhalation and dermal route and thus will not be considered for further classification
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