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EC number: 228-768-4 | CAS number: 6358-31-2
- 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
Acute oral toxicity:
Acute toxicity after single oral application was tested in male and female rats, which received 2000 mg/kg bw (OECD and GLP
guideline compliant study) or 10,000 mg/kg bw or 15,000 mg/kg bw (pre-guideline studies). No animals in these studies died. The LD50 value for acute oral toxicity is >10,000 mg/kg bw.
Acute dermal toxicity:
A close analogue of the substance did not exert any local or systemic adverse effects.
Acute inhalation toxicity:
Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust.
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
- Study period:
- 15 Jan - 11 Apr 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was performed in accordance with OECD and GLP guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxicology Department Rallis Research Centre, Bangalore, India
- Age at study initiation: 13 weeks
- Weight at study initiation: Males 281-316 g, females 179-191 g
- Fasting period before study: 16-18 hours
- Housing: individually in suspended stainless steel wire mesh cages with stainless steel top grill
- Diet (e.g. ad libitum): Ssniff rats/mice food, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water (e.g. ad libitum): purified deep bore well water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24 °C
- Humidity (%): 30-70 % relative humidity
- Air changes (per hr): adequate fresh air supply
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: refined ground nut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: ground nut oil gave a suitable suspension of the test material
- Lot/batch no. (if required): not stated
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kig - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: four times on test day one and once daily during days 2-15, body weights were recoreded on days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Statistics:
- not applicable for limit test
- Preliminary study:
- In a pretest, the test item was given at 2000 mg/kg bw to 2 male and 2 female rats. No toxic signs and pre-terminal deaths occurred.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No pre-terminal deaths occurred.
- Clinical signs:
- other: No clinical signs were observed. The faeces of all rats had test item stain during days 2 and 3, which disappeared completely from day 4 onwards.
- Gross pathology:
- No abnormalities were observed.
- Other findings:
- none
- Interpretation of results:
- not classified
- Remarks:
- LD50 >2000 mg/kg bw Criteria used for interpretation of results: other: EU DSD and EU CLP
- Conclusions:
- 67/548/EEC: Acute oral toxicity: no classification warranted
1272/2008/EC: Acute oral toxicity: no classification warranted
No death were seen in an OECD and GLP compliant acute oral toxicity study in male and female Wistar rats after single oral application of 2000 mg/kg of Hansa Brilliant Yellow 5GX IN (Pigment Yellow 74).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 07 DEC 2011 to 21 DEC 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 402) and according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (RccHan:WIST) strain rats.
On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200g, and were eight to twelve weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 Hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- The appropriate amount of test item, mixed with arachis oil BP, was applied as evenly as possible to an area of shaved skin (approximately 10% of the total body surface area).
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 Male
5 Female - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Frequency of observations: first day: 4 times, thereafter once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions - Statistics:
- No statistical analysis was performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died within the observation period
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal Reactions
Yellow coloured staining was noted at the test sites of all animals during the study. The staining prevented accurate evaluation of erythema in all animals one day after dosing.
Very slight erythema was noted at the test site of one female five to eight days after dosing. Crust formation and small superficial scattered scabs were also noted at this site. There were no signs of dermal irritation noted in the remaining animals. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
- Introduction.
The study was performed to
assess the acute dermal toxicity of the test item in the Wistar strain
rat. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008
Method.
A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
There were no signs of systemic toxicity.
Dermal Irritation.
Very slight erythema was noted at the test site of one female. Crust formation and small superficial scattered scabs were also noted at this site. No other signs of dermal irritation were noted.
Bodyweight.
Animals showed expected gains in bodyweight over the study period except for one female which showed expected gain in bodyweight during the first week but slight bodyweight loss during the second week.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 07 DEC 2011 to 21 DEC 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 402) and according to GLP.
- Justification for type of information:
- please see read across document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (RccHan:WIST) strain rats.
On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200g, and were eight to twelve weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 Hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- The appropriate amount of test item, mixed with arachis oil BP, was applied as evenly as possible to an area of shaved skin (approximately 10% of the total body surface area).
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 Male
5 Female - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Frequency of observations: first day: 4 times, thereafter once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions - Statistics:
- No statistical analysis was performed.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animal died within the observation period
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal Reactions
Yellow coloured staining was noted at the test sites of all animals during the study. The staining prevented accurate evaluation of erythema in all animals one day after dosing.
Very slight erythema was noted at the test site of one female five to eight days after dosing. Crust formation and small superficial scattered scabs were also noted at this site. There were no signs of dermal irritation noted in the remaining animals. - Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction. The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008
Method.
A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
There were no signs of systemic toxicity.
Dermal Irritation.
Very slight erythema was noted at the test site of one female. Crust formation and small superficial scattered scabs were also noted at this site. No other signs of dermal irritation were noted.
Bodyweight.
Animals showed expected gains in bodyweight over the study period except for one female which showed expected gain in bodyweight during the first week but slight bodyweight loss during the second week.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Since in the acute oral toxicity studies no adverse effects were observed, the NOAEL for a single acute oral administration of Pigment Yellow 74 is 10,000 mg/kg bw.
Justification for classification or non-classification
Due to the findings described above (LD50 oral in rats >2000 mg/kg bw) Pigment Yellow 74 has not to be classified as acute orally toxic according to the criteria laid down in the EU Dangerous Substances Directive (67/548/) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
It can reasonably be deduced that Pigment Yellow 74 does not exert systemic toxic effects after dermal application and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because
- Pigment Yellow 74 did not cause lethal effects after administration of a single oral dose of up to 15,000 mg/kg in rats,
- Pigment Yellow 74 does not have to be classified as skin irritating, and
- it is unlikely that Pigment Yellow 74 becomes systemically bioavailable after skin contact due to its extremely low solubility in water and n-octanol.
Additionally, a close analogue substance did not cause adverse effects afeter dermal exposure.
Furthermore, Pigment Yellow 74 does not have to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute exposure.
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