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EC number: 270-109-8 | CAS number: 68411-20-1
- 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
In a subacute study Butanal, reaction products with aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done.
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. As vehicle corn oil was used. The administration volume was 5 mL/kg.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- at least 32 days
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:
0, 25, 100 or 400 mg/kg body weight
Basis:
other: nominal - No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed.
- Sacrifice and pathology:
- Organs and tissues were subjected to gross and histopathological investigation.
- Other examinations:
- Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Detailed clinical observations and in-cage observations revealed increased salivation in females starting at 1 00 mg/kg and in males at 400 mg/kg. In addition, distended abdomen was found in both sexes at 400 mg/kg. In addition, signs of impaired general condition (curved back, labored breathing, bloody nose, bloody muzzle) were seen in some male animals at 400 mg/kg. Furthermore, females showed dark-yellowish urine.
- Mortality:
- no mortality observed
- Description (incidence):
- All animals survived until scheduled necropsy.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights were reduced significantly in male rats at 400 mg/kg and a trend was seen at 100 mg/kg. Females did not show any effects.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food intake was comparable to controls at the doses of25 and 100 mg/kg in males and in all dosed females. At the high dose of 400 mg/kg in males, a decrease in food intake (-15.7%) was found.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- The water intake of males was not altered up to the dose of 100 mg/kg; at 400 mg/kg the water intake was increased. In females, water intake was increased at 1 00 and 400 mg/kg.
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg: ERY, HB, HCT, MCHC were decreased in both sexes. MCH,MCV, and RETI increased in both sexes. In addition, THRO was increased in both sexes and Hep-Quick decreased in females only. For some of the parameters, a trend was already found at 25 mg/kg, however, the difference to controls was in the range of physiological adaptive reactions. In white cell parameters no relevant effect occurred.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical chemistry showed an increase of UREA and an increase of K at 400 mg/kg in both sexes. In addition, an increase in ALA T was found in both sexes at 400 mg/kg which is considered as adaptive change due to liver weight increase. APh (starting at 25 mg/kg), GLUCOSE (starting at 100 mg/kg), CHOL (starting at 100 mg/kg) were lower in both sexes and CREA was lower in females ( 400 mg/kg). These findings are indicators of changes in metabolism, possibly related to the reduced food intake and the lower body weight gain.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- An increase in ALA T was found in both sexes at 400 mg/kg which is considered as adaptive change due to liver weight increase. APh (starting at 25 mg/kg), GLUCOSE (starting at 100 mg/kg), CHOL (starting at 100 mg/kg) were lower in both sexes and CREA was lower in females ( 400 mg/kg). These findings are indicators of changes in metabolism, possibly related to the reduced food intake and the lower body weight gain.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- Functional observations revealed no toxicological relevant effects up to 400 mg/kg. Body temperature was slightly decreased at 100 and 400 mg/kg in females and rearing was decreased at 400 mg/kg in females. Male animals were not affected. The activity determination over the entire 60-minute observation period revealed no statistically significant effect on motor (MA) and locomotor activity (LMA) up to 400 mg/kg.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weights were changed as follows: Adrenals, heart, liver and spleen weights were increased in both sexes at 400 mg/kg. Thymus weights were decreased in both sexes at 400 mg/kg.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Necropsy revealed discoloration of the spleen in all animals at 100 and 400 mglkg and organ enlargement at 400 mg/kg. Discoloration of the liver and kidneys occurred in single animals of both genders at 400 mg/kg. These findings corresponded to an increased blood amount in the spleen and/or to pigment deposition in the named organs.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histopathology showed changes in various organs:
- Spleen: Increased extramedullary hematopoiesis starting at 25 mg/kg in males and at 400 mg/kg in females; increased pigment deposition starting at 25 mg/kg in females and at 100 mg/kg in males; sinus congestion starting at 25 mg/kg; thickening of the splenic capsule starting at 100 mg/kg; Prussian blue stain showed increased iron deposition at 25 mg/kg and above. The extent of the changes at 25 mg/kg was minimal and is
considered in the range of physiological adaptive reactions.
- Liver: Hepatocellular hypertrophy at 100 mg/kg (males only) and at 400 mg/kg in both sexes; increased hepatocellular vacuolation at 400 mg/kg; Oil Red 0 stain showed an increased accumulation of fat in hepatocytes at 400 mg/kg and Prussian blue stain revealed increased iron deposition in Kupffer cells at 400 mg/kg.
- Heart: Myocardial vacuolation starting at 100 mg/kg; myocardial hypertrophy and mononuclear cell infiltration at 400 mg/kg.
- Bone marrow (femur and sternum): Increase in cellularity starting at 100 mg/kg.
- Thyroid gland: Hyertrophy/hyperplasia of follicular cell epithelia at 100 mg/kg and above.
- Kidneys: Tubular swelling/degeneration at 100 mg/kg and above (males only); increased pigment deposition at 100 mg/kg (females only) and at 400 mg/kg in both sexes.
- Adrenals: Increased vacuolation of zona fasciculata cells at 100 mg/kg (males only) and 400 mg/kg in both genders. - Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other:
- Remarks:
- Under the conditions described above, a NOEL (no-observed- effect-level) for Butanal, Reaction Products with Aniline after 4-week daily oral treatment by gavage cannot be established for both sexes due to the findings at the low dose of 25 mg/kg affecting red blood cells and spleen. As the extent of the findings is in the range of physiological adaptive reactions, the low dose of 25 mg/kg is still regarded as NOAEL. At 100 mg/kg and higher, clear-cut adverse effects were identified affecting also other organs. In addition, signs of general toxicity occurred.
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- System:
- other: Spleen, liver, heart, bone marrow, thyroid gland, kidneys, adrenals
- Organ:
- adrenal glands
- bone marrow
- heart
- kidney
- liver
- spleen
- thyroid gland
- Treatment related:
- yes
- Dose response relationship:
- yes
- Conclusions:
- Under the conditions described above, a NOEL (no-observed- effect-level) for Butanal, Reaction Products with Aniline after 4-week daily oral treatment by gavage cannot be established for both sexes due to the findings at the low dose of 25 mg/kg affecting red blood cells and spleen. As the extent of the findings is in the range of physiological adapative reactions, the low dose of 25 mg/kg is still regarded as NOAEL. At 100 mg/kg and higher,
clear-cut adverse effects were identified affecting also other organs. In addition, signs of general toxicity occurred. - Executive summary:
Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. As vehicle cornoil was used. The administration volume was 5 mL/kg.
The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done.
Test substance formulations were stable during the period of use. Content checks during the study revealed correct concentrations of the test substance in the formulations used.
All animals survived until scheduled necropsy.
Detailed clinical observations and in-cage observations revealed increased salivation in females starting at 100 mg/kg and in males at 400 mg/kg. In addition, signs of impaired general condition were seen in some male animals at 400 mg/kg. Furthermore, females showed dark-yellowish urine.
Functional observations revealed no toxicological relevant effects up to 400 mg/kg.
Body weights were reduced significantly in male rats at 400 mg/kg and a trend was seen at 100 mg/kg. Females did not show any effects.
Food intake was comparable to controls at the doses of 25 and 100 mg/kg in males and in all dosed females.
The water intake of males was not altered up to the dose of 100 mg/kg.
Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg. In white cell parameters no relevant effect occurred.
Clinical chemistry showed an increase of UREA and an increase of K at 400 mg/kg in both sexes.
In addition, an increase in ALAT was found in both sexes at 400 mg/kg which is considered as adaptive change due to liver weight increase. APh (starting at 25 mg/kg), GLUCOSE (starting at 100 mg/kg), CHOL (starting at 100 mg/kg) were lower in both sexes and CREA was lower in females (400 mg/kg). These findings are indicators of changes in metabolism, possibly related to the reduced food intake and the lower body weight gain.
Organ weights were changed as follows: Adrenals, heart, liver and spleen weights were increased in both sexes at 400 mg/kg. Thymus weights were decreased in both sexes at 400 mg/kg.
Necropsy revealed discoloration of the spleen in all animals at 100 and 400 mg/kg and organ enlargement at 400 mg/kg. Discoloration of the liver and kidneys occurred in single animals of both genders at 400 mg/kg. These findings corresponded to an increased blood amount in the spleen and/or to pigment deposition in the named organs.
Histopathology showed changes in various organs:
- Spleen: Increased extramedullary hematopoiesis starting at 25 mg/kg in males and at 400 mg/kg in females; increased pigment deposition starting at 25 mg/kg in females and at 100 mg/kg in males; sinus congestion starting at 25 mg/kg; thickening of the splenic capsule starting at 100 mg/kg; Prussian blue stain showed increased iron deposition at 25 mg/kg and above. The extent of the changes at 25 mg/kg was minimal and is considered in the range of physiological adaptive reactions.
- Liver: Hepatocellular hypertrophy at 100 mg/kg (males only) and at 400 mg/kg in both sexes; increased hepatocellular vacuolation at 400 mg/kg; Oil Red O stain showed an increased accumulation of fat in hepatocytes at 400 mg/kg and Prussian blue stain revealed increased iron deposition in Kupffer cells at 400 mg/kg.
- Heart: Myocardial vacuolation starting at 100 mg/kg; myocardial hypertrophy and mononuclear cell infiltration at 400 mg/kg
- Bone marrow (femur and sternum): Increase in cellularity starting at 100 mg/kg
- Thyroid gland: Hyertrophy/hyperplasia of follicular cell epithelia at100 mg/kg and above
- Kidneys: Tubular swelling/degeneration at 100 mg/kg and above (males only); increased pigment deposition at 100 mg/kg (females only) and at 400 mg/kg in both sexes
- Adrenals: Increased vacuolation of zona fasciculata cells at 100 mg/kg (males only) and 400 mg/kg in both genders
Conclusion:
Under the conditions described above, a NOEL (no-observed- effect-level) for Butanal, Reaction Products with Aniline after 4-week daily oral treatment by gavage cannot be established for both sexes due to the findings at the low dose of 25 mg/kg affecting red blood cells and spleen. As the extent of the findings is in the range of physiological adapative reactions, the low dose of 25 mg/kg is still regarded as NOAEL. At 100 mg/kg and higher, clear-cut adverse effects were identified affecting also other organs. In addition, signs of general toxicity occurred.
Reference
All animals survived until scheduled necropsy.
Detailed clinical observations and in-cage observations revealed increased salivation in females starting at 100 mg/kg and in males at 400 mg/kg. In addition, distended abdomen was found in both sexes at 400 mg/kg. In addition, signs of impaired general condition (curved back, labored breathing, bloody nose, bloody muzzle) were seen in some male animals at 400 mg/kg. Furthermore, females showed dark-yellowish urine.
Functional observations revealed no toxicological relevant effects up to 400 mg/kg. Body temperature was slightly decreased at 100 and 400 mg/kg in females and rearing was decreased at 400 mg/kg in females. Male animals were not affected. The activity determination over the entire 60-minute observation period revealed no statistically significant effect on motor (MA) and locomotor activity (LMA) up to 400 mg/kg.
Body weights were reduced significantly in male rats at 400 mg/kg and a trend was seen at 100 mg/kg. Females did not show any effects.
Food intake was comparable to controls at the doses of 25 and 100 mg/kg in males and in all dosed females. At the high dose of 400 mg/kg in males, a decrease in food intake (-15.7%) was found.
The water intake of males was not altered up to the dose of 100 mg/kg; at 400 mg/kg the water intake was increased. In females, water intake was increased at 100 and 400 mg/kg.
Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg: ERY (erytrocytes), HB (hemoglobin), HCT (hematocrit), MCHC (mean corpuscular hemoglobin concentration) were decreased in both sexes. MCH (mean corpuscular hemoglobine), MCV (mean corpuscular volume), and RETI (reticulocytes) increased in both sexes. In addition, THRO (platelets/thrombocytes) was increased in both sexes and Hep-Quick decreased in females only. For some of the parameters, a trend was already found at 25 mg/kg, however, the difference to controls was in the range of physiological adaptive reactions.
In white cell parameters no relevant effect occurred.
Clinical chemistry showed an increase of UREA and an increase of K at 400 mg/kg in both sexes.
In addition, an increase in ALAT was found in both sexes at 400 mg/kg which is considered as adaptive change due to liver weight increase. APh (starting at 25 mg/kg), GLUCOSE (starting at 100 mg/kg), CHOL (starting at 100 mg/kg) were lower in both sexes and CREA was lower in females (400 mg/kg). These findings are indicators of changes in metabolism, possibly related to the reduced food intake and the lower body weight gain.
Organ weights were changed as follows: Adrenals, heart, liver and spleen weights were increased in both sexes at 400 mg/kg. Thymus weights were decreased in both sexes at 400 mg/kg.
Necropsy revealed discoloration of the spleen in all animals at 100 and 400 mg/kg and organ enlargement at 400 mg/kg. Discoloration of the liver and kidneys occurred in single animals of both genders at 400 mg/kg. These findings corresponded to an increased blood amount in the spleen and/or to pigment deposition in the named organs.
Histopathology showed changes in various organs:
- Spleen: Increased extramedullary hematopoiesis starting at 25 mg/kg in males and at 400 mg/kg in females; increased pigment deposition starting at 25 mg/kg in females and at 100 mg/kg in males; sinus congestion starting at 25 mg/kg; thickening of the splenic capsule starting at 100 mg/kg; Prussian blue stain showed increased iron deposition at 25 mg/kg and above. The extent of the changes at 25 mg/kg was minimal and is considered in the range of physiological adaptive reactions.
- Liver: Hepatocellular hypertrophy at 100 mg/kg (males only) and at 400 mg/kg in both sexes; increased hepatocellular vacuolation at 400 mg/kg; Oil Red O stain showed an increased accumulation of fat in hepatocytes at 400 mg/kg and Prussian blue stain revealed increased iron deposition in Kupffer cells at 400 mg/kg.
- Heart: Myocardial vacuolation starting at 100 mg/kg; myocardial hypertrophy and mononuclear cell infiltration at 400 mg/kg
- Bone marrow (femur and sternum): Increase in cellularity starting at 100 mg/kg
- Thyroid gland: Hyertrophy/hyperplasia of follicular cell epithelia at100 mg/kg and above
- Kidneys: Tubular swelling/degeneration at 100 mg/kg and above (males only); increased pigment deposition at 100 mg/kg (females only) and at 400 mg/kg in both sexes
- Adrenals: Increased vacuolation of zona fasciculata cells at 100 mg/kg (males only) and 400 mg/kg in both genders
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
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
All animals survived until scheduled necropsy. Functional observations revealed no toxicological relevant effects up to 400 mg/kg.
Body weights were reduced significantly in male rats at 400 mg/kg bw. At the high dose of 400 mg/kg in males, a decrease in food intake (-15.7%) was found. The water intake of males was increased at 400 mg/kg. In females, water intake was increased at 100 and 400 mg/kg.
Hematology revealed statistically significant changes in red blood parameters in both sexes at 100 mg/kg and/or 400 mg/kg: ERY, HB, HCT, MCHC were decreased in both sexes. MCH, MCV, and RETI increased in both sexes. In addition, THRO was increased in both sexes and Hep-Quick decreased in females only. For some of the parameters, a trend was already found at 25 mg/kg, however, the difference to controls was in the range of physiological adaptive reactions.
In white cell parameters no relevant effect occurred.
Clinical chemistry showed an increase of UREA and an increase of K at 400 mg/kg in both sexes.
In addition, an increase in ALAT was found in both sexes at 400 mg/kg which is considered as adaptive change due to liver weight increase. APh (starting at 25 mg/kg), GLUCOSE (starting at 100 mg/kg), CHOL (starting at 100 mg/kg) were lower in both sexes and CREA was lower in females (400 mg/kg). These findings are indicators of changes in metabolism, possibly related to the reduced food intake and the lower body weight gain.
Organ weights were changed as follows: Adrenals, heart, liver and spleen weights were increased in both sexes at 400 mg/kg. Thymus weights were decreased in both sexes at 400 mg/kg.
Necropsy revealed discoloration of the spleen in all animals at 100 and 400 mg/kg and organ enlargement at 400 mg/kg. Discoloration of the liver and kidneys occurred in single animals of both genders at 400 mg/kg. These findings corresponded to an increased blood amount in the spleen and/or to pigment deposition in the named organs.
Histopathology showed changes in various organs:
- Spleen: Increased extramedullary hematopoiesis starting at 25 mg/kg in males and at 400 mg/kg in females; increased pigment deposition starting at 25 mg/kg in females and at 100 mg/kg in males; sinus congestion starting at 25 mg/kg; thickening of the splenic capsule starting at 100 mg/kg; Prussian blue stain showed increased iron deposition at 25 mg/kg and above. The extent of the changes at 25 mg/kg was minimal and is considered in the range of physiological adaptive reactions.
- Liver: Hepatocellular hypertrophy at 100 mg/kg (males only) and at 400 mg/kg in both sexes; increased hepatocellular vacuolation at 400 mg/kg; Oil Red O stain showed an increased accumulation of fat in hepatocytes at 400 mg/kg and Prussian blue stain revealed increased iron deposition in Kupffer cells at 400 mg/kg.
- Heart: Myocardial vacuolation starting at 100 mg/kg; myocardial hypertrophy and mononuclear cell infiltration at 400 mg/kg
- Bone marrow (femur and sternum): Increase in cellularity starting at 100 mg/kg
- Thyroid gland: Hypertrophy/hyperplasia of follicular cell epithelia at100 mg/kg and above
- Kidneys: Tubular swelling/degeneration at 100 mg/kg and above (males only); increased pigment deposition at 100 mg/kg (females only) and at 400 mg/kg in both sexes
- Adrenals: Increased vacuolation of zona fasciculata cells at 100 mg/kg (males only) and 400 mg/kg in both genders
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
key study used
Justification for classification or non-classification
Due to the hematological and histopathological findings of butanal, reaction products with aniline (aniline content: 0.4 %) a classification as Stot Re 2, H373 (GHS) is justified.
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