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EC number: 915-600-6 | CAS number: 64553-79-3
- 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
Read Across approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source substance Solvent Blue 98:
Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat , M/F, OECD guideline 422, GLP
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX - Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- pancreas
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- System:
- hepatobiliary
- Organ:
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- Based on read across to an analogue substance, The value of NOAEL (No Observed Adverse Effect Level) for repeated dose toxicity of Solvnet Blue 79 is predicted to be 100 mg/kg body weight/day for females. The value was established for the analogue substance Solvent Blue 98 based upon the increase in necrosis/apoptosis of pancreatic acinar cells at 300mg/kg/day. A NOAEL could not be determined for males due to an increase in necrosis/apoptosis of pancreatic acinar cells in males at all dose levels.
- Executive summary:
A read across approach was used to evaluate potential toxicity effects of Solvent Blue 79 following repeated oral exposure ( Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione).
An analogue substance Solvent Blue 98 was tested according to OECD guideline 422. The analogue substance is compositionally very similar. It is also anthraquinone based, with aliphatic amine substitutions. Where the Solvent Blue 79 contains ethylhexyl amine groups, methyl amine groups and butylamine groups, the Solvent Blue 98 contains ethylhexyl, methyl and pentyl groups. There is therefore overlap in the compositions and the structures are very similar. Further supporting information on the readacross approach has been provided in section 13 (Read across justification document).
Based on read across to an analogue substance, The value of NOAEL (No Observed Adverse Effect Level) for repeated dose toxicity of Solvent Blue 79 is predicted to be 100 mg/kg body weight/day for females. The value was established for the analogue substance Solvent Blue 98 based upon the increase in necrosis/apoptosis of pancreatic acinar cells at 300mg/kg/day. A NOAEL could not be determined for males due to an increase in necrosis/apoptosis of pancreatic acinar cells in males at all dose levels.
The analogue substance results are summarised below:
Treatment-relatedclinical observations consisted of blue skin/mucous membranes and/or blue feces in all treated animals which were attributed to the dye nature of the test material.
There were no treatment-related effects on body weight, body weight gain, or feed consumption in males or females in any treated groups compared to controls.
There were no treatment-related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring in any treated groups compared to controls.
There were no treatment-related effects on sensory evaluation, rectal temperature or grip performance in males or females from any dose group. There were no treatment-related effects on motor activity in males at any dose level or in females at dose levels
≤ 300 mg/kg/day. There was a treatment-related decrease in the total motor activity of females given 1000 mg/kg/day when compared to control females. There were no treatment-related changes in the hematology parameters of males or females in any dose group. Males given 1000 mg/kg/day had a treatment-related increase in mean prothrombin time that was interpreted to be non-adverse. Males and females given 1000 mg/kg/day had treatment-related higher mean cholesterol concentrations that were interpreted to be non-adverse. Males given 100, 300 or 1000 mg/kg/day had purple discoloration of the urine, which was attributed to the dye nature of the test material present in the urine.Males and females given 100, 300 or 1000 mg/kg/day had treatment-related increases in mean absolute and relative liver weights. The higher liver weights corresponded to hepatocellular hyperthophy in males and females in all dose groups. Males given
1000 mg/kg/day had treatment-related increases in mean absolute and relative thyroid gland weights. The higher thyroid gland weights corresponded to slight diffuse hypertrophy of follicular cells in males given 1000 mg/kg/day.All male and female rats given 100, 300 or 1000 mg/kg/day had a blue discoloration of various tissues throughout the body attributed to the presence of the test material. The blue discoloration was most prominent in adipose tissue. Limited gross pathological observations on postpartum day 4 pups revealed blue adipose tissue and stomach contents in pups from all treated groups. This discoloration was attributed to the dye nature of the test material and demonstrated systemic exposure to the pups via the milk.
A treatment-related histopathologic effect in the liver consisted of very slight to slight hypertrophy of hepatocytes with increased cytoplasmic eosinophilia. The hypertrophy was present in the centrilobular/midzonal regions of the hepatic lobule in the male 100 and
300 mg/kg/day groups and all treated female groups. In some males from the
300 mg/kg/day group and all males in the 1000 mg/kg/day group, the hypertrophy was panlobular. The hepatocellular hypertrophy was interpreted to be an adverse effect in the male and female 1000 mg/kg/day groups because the corresponding increases in mean relative liver weights were at least 25% higher than the control group mean.A treatment-related histopathologic effect occurred in the thyroid glands of males given
1000 mg/kg/day and consisted of a slight hypertrophy of the follicular epithelial cells. This was interpreted to be a non-adverse adaptive response likely secondary to the induction of liver microsomal enzymes.Treatment-related histopathologic effects in the pancreas involved the exocrine tissue, not the islets of Langerhans, and consisted of a slight increase in apoptosis/necrosis of acinar cells and in individual autophagic/vacuolated acinar cells. These treatment-related effects were present in all male dose groups and in the female 300 and 1000 mg/kg/day dose groups. The apoptosis/necrosis of pancreatic acinar cells was interpreted to be an adverse effect.
A treatment-related histopathologic effect in the kidneys consisted of a slight increase in the accumulation of hyaline protein droplets in the cytoplasm of tubular epithelial cells of the proximal convoluted tubules in males given 1000 mg/kg/day. This observation was interpreted to be a non-adverse effect because it was not accompanied by degeneration or necrosis of the tubular epithelial cells and because hyaline droplet nephropathy is a male rat specific lesion with no significant relevance to humans.
Results for thePig-aassay showed no significant change in the frequency of RETCD59-or RBCCD59-in animals treated with the test material. Therefore, C.I. Solvent Blue 98 (3 Amine) was negative in thisin vivogene mutationPig-aassay.
A no-observed-effect level (NOEL) for general toxicity could not be determined for male or female rats due to the occurrence of treatment-related effects at all dose levels. A no-observed-adverse-effect level (NOAEL) could not be determined for males because of the increase in necrosis/apoptosis of pancreatic acinar cells in males from all treated groups. The NOAEL for females was 100 mg/kg/day based upon the increase in necrosis/apoptosis of pancreatic acinar cells at 300 mg/kg/day. The NOEL for neurological toxicity was
300 mg/kg/day in females and 1000 mg/kg/day in males, the highest dose level tested. The NOEL for reproductive toxicity or for effects on prenatal/neonatal growth and survival was 1000 mg/kg/day, the highest dose level tested.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- good
- System:
- gastrointestinal tract
- Organ:
- pancreas
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A read across approach was used to evaluate potential toxicity effects of Solvent Blue 79 following repeated oral exposure ( Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione).
An analogue substance Solvent Blue 98 was tested according to OECD guideline 422. The analogue substance is compositionally very similar. It is also anthraquinone based, with aliphatic amine substitutions. Where the Solvent Blue 79 contains ethylhexyl amine groups, methyl amine groups and butylamine groups, the Solvent Blue 98 contains ethylhexyl, methyl and pentyl groups. There is therefore overlap in the compositions and the structures are very similar. Further supporting information on the readacross approach has been provided in section 13 (Read across justification document).
Based on read across to an analogue substance, The value of NOAEL (No Observed Adverse Effect Level) for repeated dose toxicity of Solvent Blue 79 is predicted to be 100 mg/kg body weight/day for females. The value was established for the analogue substance Solvent Blue 98 based upon the increase in necrosis/apoptosis of pancreatic acinar cells at 300mg/kg/day. A NOAEL could not be determined for males due to an increase in necrosis/apoptosis of pancreatic acinar cells in males at all dose levels.
The analogue substance results are summarised below:
Treatment-related clinical observations consisted of blue skin/mucous membranes and/or blue feces in all treated animals which were attributed to the dye nature of the test material.
There were no treatment-related effects on body weight, body weight gain, or feed consumption in males or females in any treated groups compared to controls.
There were no treatment-related effects on reproductive function in either males or females or prenatal/early neonatal growth and survival of offspring in any treated groups compared to controls.
There were no treatment-related effects on sensory evaluation,
rectal temperature or grip performance in males or females from any
dose group. There were no treatment-related effects on motor activity
in males at any dose level or in females at dose levels
≤ 300 mg/kg/day. There was a treatment-related decrease in the total
motor activity of females given 1000 mg/kg/day when compared to
control females. There were no treatment-related changes in the
hematology parameters of males or females in any dose group. Males
given 1000 mg/kg/day had a treatment-related increase in mean
prothrombin time that was interpreted to be non-adverse. Males and
females given 1000 mg/kg/day had treatment-related higher mean
cholesterol concentrations that were interpreted to be
non-adverse. Males given 100, 300 or 1000 mg/kg/day had purple
discoloration of the urine, which was attributed to the dye nature of
the test material present in the urine.
Males and females given 100, 300 or 1000 mg/kg/day had
treatment-related increases in mean absolute and relative liver
weights. The higher liver weights corresponded to hepatocellular
hyperthophy in males and females in all dose groups. Males given
1000 mg/kg/day had treatment-related increases in mean absolute and
relative thyroid gland weights. The higher thyroid gland weights
corresponded to slight diffuse hypertrophy of follicular cells in
males given 1000 mg/kg/day.
All male and female rats given 100, 300 or 1000 mg/kg/day had a blue discoloration of various tissues throughout the body attributed to the presence of the test material. The blue discoloration was most prominent in adipose tissue. Limited gross pathological observations on postpartum day 4 pups revealed blue adipose tissue and stomach contents in pups from all treated groups. This discoloration was attributed to the dye nature of the test material and demonstrated systemic exposure to the pups via the milk.
A treatment-related histopathologic effect in the liver
consisted of very slight to slight hypertrophy of hepatocytes with
increased cytoplasmic eosinophilia. The hypertrophy was present in the
centrilobular/midzonal regions of the hepatic lobule in the male 100
and
300 mg/kg/day groups and all treated female groups. In some males from
the
300 mg/kg/day group and all males in the 1000 mg/kg/day group, the
hypertrophy was panlobular. The hepatocellular hypertrophy was
interpreted to be an adverse effect in the male and female 1000
mg/kg/day groups because the corresponding increases in mean relative
liver weights were at least 25% higher than the control group mean.
A treatment-related histopathologic effect occurred in the
thyroid glands of males given
1000 mg/kg/day and consisted of a slight hypertrophy of the follicular
epithelial cells. This was interpreted to be a non-adverse adaptive
response likely secondary to the induction of liver microsomal enzymes.
Treatment-related histopathologic effects in the pancreas involved the exocrine tissue, not the islets of Langerhans, and consisted of a slight increase in apoptosis/necrosis of acinar cells and in individual autophagic/vacuolated acinar cells. These treatment-related effects were present in all male dose groups and in the female 300 and 1000 mg/kg/day dose groups. The apoptosis/necrosis of pancreatic acinar cells was interpreted to be an adverse effect.
A treatment-related histopathologic effect in the kidneys consisted of a slight increase in the accumulation of hyaline protein droplets in the cytoplasm of tubular epithelial cells of the proximal convoluted tubules in males given 1000 mg/kg/day. This observation was interpreted to be a non-adverse effect because it was not accompanied by degeneration or necrosis of the tubular epithelial cells and because hyaline droplet nephropathy is a male rat specific lesion with no significant relevance to humans.
Results for thePig-aassay showed no significant change in the frequency of RETCD59-or RBCCD59-in animals treated with the test material. Therefore, C.I. Solvent Blue 98 (3 Amine) was negative in thisin vivogene mutationPig-aassay.
A no-observed-effect level (NOEL) for general toxicity could not
be determined for male or female rats due to the occurrence of
treatment-related effects at all dose levels. A
no-observed-adverse-effect level (NOAEL) could not be determined for
males because of the increase in necrosis/apoptosis of pancreatic
acinar cells in males from all treated groups. The NOAEL for females
was 100 mg/kg/day based upon the increase in necrosis/apoptosis of
pancreatic acinar cells at 300 mg/kg/day. The NOEL for neurological
toxicity was
300 mg/kg/day in females and 1000 mg/kg/day in males, the highest dose
level tested. The NOEL for reproductive toxicity or for effects on
prenatal/neonatal growth and survival was 1000 mg/kg/day, the highest
dose level tested.
Justification for classification or non-classification
Based on read across to the analogue source substance solvent blue 98, classification for repeat dose toxicity is not justified. Although an adverse effect was observed in the pancreas, it was interpreted to be insufficient in severity to warrant classification. The functioning of the pancreas was not impacted, and there were no other observations indicating that the organ had been damaged to an extent that it could not perform its biological functions.
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