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EC number: 411-080-5 | CAS number: -
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 98 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 490 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 70 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Workers - Hazard for the eyes
Additional information - workers
Pigment Yellow FC 26290 (CAS 111071-53-5)
DNELs (worker)
Repeated dose toxicity
Basis for delineation of the DNEL:
Study
Repeated dose study (28 day oral)
Male and female Wistar rats received Pigment Yellow FC 26290 by gavage for 28 days.
rat: 0 (control), 40, 200 or 1000 mg/kg bw/d – male/female rats
Effects, NOAEL
NOAEL = 1000 mg/kg bw/day (male/female rats)
Appearance and general behaviour were not influenced by treatment up to and including 1000 mg/kg bw/d. The general condition was temporarily reduced in some animals of the dose group 1000 mg/kg bw/d., but this observation is not considered to be adverse.
Growth, mortality, feed and water intake were not affected by treatment.
Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg bw/d.
Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.
Under the conditions of this study, Pigment Yellow FC 26290 was tolerated without adverse effects in dosages of up to and including 1000 mg/kg bw/d.
Reference
Bomhard E, Rosenbruch M
Pigment Yellow FC 26290
Subacute toxicity study in Wistar rats (administration by gavage for 28 days with a subsequent recovery period of 14 days)
Report-no.: 22215 + 22215 A (1993)
Bayer AG,
Fachbereich Toxikologie, Wuppertal
1.) Long-term toxicity – systemic effects (worker)
Long-term oral or dermal route-systemic effects (worker) using extrapolation factors:
NOAEL(rat) from a 28 day study: 1000 mg/kg bw/day
Penetration oral compared to dermal: 1
For interspecies differences rat vs. human: 4
For remaining interspecies differences: 1*
For intraspecies differences in workers: 3**
For extrapolation of exposure duration: 6***
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 72
Worker DNEL long-term for oral or dermal route-systemic: 13.88 mg/kg bw/day
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study). Overall it is likely that bioavailability is very low and consequently toxikodynamic parameters are of minor significance.
** An assessment factor of 3 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study). Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetoc and metabolism is of limited significance.
*** An assessment factor of 6 is used although this factor seems to be very conservative, based on the low toxicity observed in the sub-acute toxicity studying rats after 28 days of exposure and in the developmental screening study in which the animals are longer exposed 36 days of exposure in male rats and 57 days of exposure in female rats.
Long-term inhalation route-systemic effects (worker):
NOAEL(rat) from a 28 day study: 1000 mg/kg bw/day
Correction of the starting point according TGD Figure R.8-3:
Corrected inhalatory NOAEC = Oral NOAEL (1000 mg/kg) x 1/0.38 m³/kg x 6.7 m³/10m³ x 1
=> NOAEC worker = 1763.15 mg/m³
For interspecies differences rat vs. human: 1 (according TGD Table
R.8-4. already covered by correction of starting point)
For remaining interspecies differences: 1*
For intraspecies differences in worker: 3**
For extrapolation of exposure duration: 6***
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 18
Worker DNEL long-term for inhalation exposure: 97.95 mg/m³
2.) Short-term toxicity – systemic effects (worker)
Concerning the systemic effects an exceeding factor of 5 based on the DNEL for long term exposure seems justified based on the REACH Guidance documents and due to the low toxicity of the substance (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study).
Therefore the
Worker DNELshort-term for oral or dermal route-systemic: 69.4 mg/kg bw/day
Worker DNEL short-term for inhalation exposure: 489.8 mg/m³
3.) Reproductive Toxicity – systemic effects (workers)
A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, No. 421 „Reproduction/Developmental Toxicity Screening Test“.
In the reproduction/developmental toxicity screening test in rats the compound did not result in any signs of parental toxicity. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity. In the screening study,1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.
In the subacute oral (gavage) toxicity study with Pigment Yellow FC 26290 in rats (28 days), no adverse effects in reproductive organs (testes, prostate glands, epididymis, vagina, uterus, ovaries with eviduct) were observed in histopathological examinations at any of the doses administered (up to about 1000 mg/kg bw/d in) (Bomhard, Bayer AG, 1993).
There is no evidence indicating a potential of Pigment Yellow FC 26290 to interfere adversely with reproduction. The NOAEL for reproductive toxicity in rats based on the histopathological examination of reproductive organs is therefore 1000 mg/kg bw/day as the lower limit.
Therefore the derivation of a separate DNEL for reproductive toxicity is not necessary, because the DNEL for repeated dose toxicty covers both endpoints.
Conclusion (systemic effects):
Worker DNEL long-term for oral or dermal route-systemic: 14 mg/kg bw/day
Worker DNEL long-term for inhalation exposure: 98 mg/m³
Worker DNEL short-term for oral or dermal route-systemic: 70 mg/kg bw/day
Worker DNEL short-term for inhalation exposure: 490 mg/m³
4. Sensitization
Pigment Yellow FC 26290 is not sensitising to the skin of guinea pigs.
5. Long-term and short-term dermal or inhalation route - local effects (worker)
Pigment Yellow FC 26290, tested according to OECD Guideline 404, is not irritating to the skin
Pigment Yellow FC 26290, tested according to OECD Guideline 405, is not irritating to the eye.
Pigment Yellow FC 29290 is not sensitizing and not irritating to the skin and eyes. Therefore a DNEL for local effects is not applicable.
Conclusion (systemic and local effects - worker):
Route of exposure DNEL; local effect DNEL; systemic effect
Oral (long term) not applicable 14 mg/kg
Oral (short term) not applicable 70 mg/kg
Dermal (long term) not applicable 14 mg/kg
Dermal (short term) not applicable 70 mg/kg
Inhalation (long term) not applicable 98 mg/m³
Inhalation (short term) not applicable 490 mg/m³
References:
• Bomhard E, Rosenbruch M. (1993). Pigment Yellow FC 26290 subacute toxicity study in Wistar rats (administration by gavage for 28 days with a subsequent recovery period of 14 days). Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxicologie, Wuppertal. Report no.: 22215 + 22215 A. Study number: T2041179.
• Dreist M, Kolb J (1992). Pigment Yellow FC 26290 Study for skin sensitization effect on guinea pigs (Maximisation test as decribed by Magnusson and Kligman). Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxicologie, Wuppertal. Report no.: 21597. Study number: T2041205
• Kroetlinger F (1992). Pigment Yellow FC 26290 Study for skin and eye irritation/corrosion in rabbits. Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxikologie, Wuppertal. Report no.: 21529. Study number: T8041175.
• Popp L (2012) Reproduction/Developmental Toxicity Screening Test in Rats after Administration by Gavage (Following OECD Guideline 421) – draft, Bayer Pharma AG, GDD-GED Toxicology, 42096 Wuppertal, Germany, Study number: T5083211
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 28 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 144 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEC
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 41 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
Pigment Yellow FC 26290 (CAS 111071-53-5)
DNELs (general population)
Repeated dose toxicity
Basis for delineation of the DNEL:
Reference
Study
Repeated dose study (28 day oral)
Male and female Wistar rats received Pigment Yellow FC 26290 by gavage for 28 days.
rat: 0 (control), 40, 200 or 1000 mg/kg bw/d – male/female rats
Effects, NOAEL
NOAEL = 1000 mg/kg bw/day (male/female rats)
Appearance and general behavior were not influenced by treatment up to and including 1000 mg/kg bw/d. The general condition was temporarily reduced in some animals of the dose group 1000 mg/kg bw/d., but this observation is not considered to be adverse.
Growth, mortality, feed and water intake were not affected by treatment.
Hematological and histopathological investigations gave no indication of toxicologically relevant damage to blood or hematopoietic organs up to and including 1000 mg/kg bw/d.
Neither clinico-chemical nor gross pathological or histopathological investigations produced any evidence of treatment-related metabolic or organ damage.
Under the conditions of this study, Pigment Yellow FC 26290 was tolerated without adverse effects in dosages of up to and including 1000 mg/kg bw/d.
Bomhard E, Rosenbruch M
Pigment Yellow FC 26290
Subacute toxicity study in Wistar rats (administration by gavage for 28 days with a subsequent recovery period of 14 days)
Report-no.: 22215 + 22215 A (1993)
Bayer AG,
Fachbereich Toxikologie, Wuppertal
1.) Long-term toxicity – systemic effects (general population)
Long-term oral or dermal route-systemic effects (worker) using extrapolation factors:
NOAEL(rat) from a 28 day study: 1000 mg/kg bw/day
Penetration oral compared to dermal (both assumed 100%) 1
For interspecies differences rat vs. human: 4
For remaining interspecies differences: 1*
For intraspecies differences in general population: 5**
For extrapolation of exposure duration: 6***
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 120
General population DNEL long-term for oral or dermal route-systemic: 8.33 mg/kg bw/day
* An assessment factor of 1 is used for “remaining interspecies differences” because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study). Overall it is likely that bioavailability is very low and consequently toxikodynamic parameters are of minor significance.
** An assessment factor of 5 is used due because of the low absorption potential of the compound (see chapter toxicokinetic) and the low toxicity profile (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study). Overall it is likely that bioavailability is very low and intraspecies differences in humans based on differences in human toxicokinetoc and metabolism is of limited significance.
*** An assessment factor of 6 is used although this factor seems to be very conservative, based on the low toxicity observed in the sub-acute toxicity studying rats after 28 days of exposure and in the developmental screening study in which the animals are longer exposed 36 days of exposure in male rats and 57 days of exposure in female rats.
Long-term inhalation route-systemic effects (general population):
NOAEL(rat) from a 28 day study: 1000 mg/kg bw/day
Correction of the starting point according TGD Figure R.8-3:
Corrected inhalatory NOEC = Oral NOEL (1000 mg/kg) x 1/1.15 m³/kg x 1.0
=> NOEC general population = 869.56 mg/m³
For interspecies differences rat vs. human: 1 (according TGD Table
R.8-4. already covered by correction of starting point)
For remaining interspecies differences: 1*
For intraspecies differences in general population: 5**
For extrapolation of exposure duration: 6***
For reliability of dose-response: 1
For quality of whole database: 1
Overall factor: 30
General population DNEL long-term for inhalation exposure: 28.98 mg/m³
2.) Short-term toxicity – systemic effects (general population)
Concerning the systemic effects an exceeding factor of 5 based on the DNEL for long term exposure seems justified based on the REACH Guidance documents and due to the low toxicity of the substance (NOAEL limit dose 1000 mg/kg in sub-acute and developmental screening study).
Therefore the
General population DNELshort-term for oral or dermal route-systemic: 41.65 mg/kg bw/day
General population DNEL short-term for inhalation exposure: 144.9 mg/m³
3.) Reproductive Toxicity – systemic effects (General population)
A reproduction/developmental toxicity screening test in rats to assess general toxicity and potential effects on fertility of the F0 generation as well as potential effects on pre- and early postnatal development of the F1 generation after oral exposure was conducted in compliance with the OECD Guideline for Testing of Chemicals, No. 421 „Reproduction/Developmental Toxicity Screening Test“.
In the reproduction/developmental toxicity screening test in rats the compound did not result in any signs of parental toxicity. Body weight and food consumption were not affected. Reproduction parameters did not indicate any effect on male or female reproductive function. In addition, no effects on developmental parameters in F0 females and on parameters measured in F1 pups were found indicating any signs of developmental toxicity. In the screening study, 1000 mg/kg represents the NOEL for male and female reproductive function and for developmental toxicity.
In the subacute oral (gavage) toxicity study with Pigment Yellow FC 26290 in rats (28 days), no adverse effects in reproductive organs (testes, prostate glands, epididymis, vagina, uterus, ovaries with eviduct) were observed in histopathological examinations at any of the doses administered (up to about 1000 mg/kg bw/d in) (Bomhard, Bayer AG, 1993).
There is no evidence indicating a potential of Pigment Yellow FC 26290 to interfere adversely with reproduction. The NOAEL for reproductive toxicity in rats based on the histopathological examination of reproductive organs is therefore 1000 mg/kg bw/day as the lower limit.
Therefore the derivation of a separate DNEL for reproductive toxicity is not necessary, because the DNEL for repeated dose toxicity covers both endpoints.
Conclusion (systemic effects):
General population DNEL long-term for oral or dermal route-systemic: 8.33 mg/kg bw/day
General population DNEL long-term for inhalation exposure: 28.98 mg/m³
General population DNEL short-term for oral or dermal route-systemic: 41.65 mg/kg bw/day
General population DNEL short-term for inhalation exposure: 144.9 mg/m³
4. Sensitization
Pigment Yellow FC 26290 is not sensitising to the skin of guinea pigs.
6. Long-term and short-term dermal or inhalation route - local effects (general population)
Pigment Yellow FC 26290, tested according to OECD Guideline 404, is not irritating to the skin
Pigment Yellow FC 26290, tested according to OECD Guideline 405, is not irritating to the eye.
Pigment Yellow FC 29290 is not sensitizing and not irritating to the skin and eyes. Therefore a DNEL for local effects is not applicable.
Conclusion (systemic and local effects – general population):
Route of exposure DNEL; local effect DNEL; systemic effect
Oral (long term) not applicable 8 mg/kg
Oral (short term) not applicable 41 mg/kg
Dermal (long term) not applicable 8 mg/kg
Dermal (short term) not applicable 41 mg/kg
Inhalation (long term) not applicable 28 mg/m³
Inhalation (short term) not applicable 144 mg/m³
References:
• Bomhard E, Rosenbruch M. (1993). Pigment Yellow FC 26290 subacute toxicity study in Wistar rats (administration by gavage for 28 days with a subsequent recovery period of 14 days). Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxicologie, Wuppertal. Report no.: 22215 + 22215 A. Study number: T2041179.
• Dreist M, Kolb J (1992). Pigment Yellow FC 26290 Study for skin sensitization effect on guinea pigs (Maximisation test as decribed by Magnusson and Kligman). Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxicologie, Wuppertal. Report no.: 21597. Study number: T2041205
• Kroetlinger F (1992). Pigment Yellow FC 26290 Study for skin and eye irritation/corrosion in rabbits. Bayer AG. Testing Laboratory: Bayer AG, Fachbereich Toxikologie, Wuppertal. Report no.: 21529. Study number: T8041175.
• Popp L (2012) Reproduction/Developmental Toxicity Screening Test in Rats after Administration by Gavage (Following OECD Guideline 421) – draft, Bayer Pharma AG, GDD-GED Toxicology, 42096 Wuppertal, Germany, Study number: T5083211
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