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EC number: 915-640-4 | 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
Endpoint summary
Administrative data
Description of key information
Several GLP and non-GLP (pre-GLP) studies containing sufficient data for the interpretation and assessment are available, including rat and dog studies, on the ADPODS category members (refer to full read-across ADPODS category justification document).
These category members differ only in structure and length of their alkyl side chains. The extent of predicted oral absorption and experimental irritation potential between all the category members was similar. Therefore, the substance properties and the structural difference would not affect or change the overall systemic toxicity potential for any of the category members including the registered substance.
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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1961-1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
- Justification for type of information:
- Please see read across justification document.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Beagle dogs were divided into matched groups and started on diets containing 0.0 (control), 1.0, 0.5, 0.25, or 0.125% Benax 2A1. Four males and four females comprised each group, except for the 1.0% level, which consisted of two males and four females. The percentage levels given above were approximately equivalent to the administration of 0, 319, 128, 65, and 34 mg/kg/day Benax 2A1, respectively, over the two-year period.
General appearance and behavior, growth, food consumption, hematological values, determinations of serum urea nitrogen content, alkaline phosphatase and transaminase activity and bromsulfophthalein dye retention, final organ and body weights, and gross and microscopic examination of the tissues were conducted. - GLP compliance:
- no
- Remarks:
- pre-GLP
- Limit test:
- no
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female beagle hounds of approximately three months of age were obtained from a commercial kennel and housed at the Biochemical Research Laboratory. The pups remained in the laboratory three months prior to the beginning of the experiment, during which time they were vaccinated for distemper, hepatitis, and leptospira. The stock diet for the first two months was Famo Labomtory Chow; it was then changed to Purina Laboratory Chow for the remaining time. Dogs of each sex per level were housed together and had free access to food and water at all times.
On October 17, 1961, the dogs were divided into matched groups. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Dogs were divided into matched groups and given diets containing 0.0 (control), 1.0, 0.5, 0.25, or 0.125% Benax 2A1. Four males and four females comprised each group, except for the 1.0% level, which consisted of two males and four females. The percentage levels given above were approximately equivalent to the administration of 0, 319, 128, 65, and 34 mg/kg/day Benax 281, respectively, over the two-year period.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0.0 (control), 1.0, 0.5, 0.25, or 0.125% Benax 2A1
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
0, 319, 128, 65, and 34 mg/kg/day Benax 2A1
Basis:
nominal in diet - No. of animals per sex per dose:
- Four males and four females comprised each group, except for the 1.0% level, which consisted of two males and four females.
- Control animals:
- yes, plain diet
- Details on study design:
- Beagle dogs were divided into matched groups and started on diets containing 0.0 (control), 1.0, 0.5, 0.25, or 0.125% Benax 2A1. Four males and four females comprised each group, except for the 1.0% level, which consisted of two males and four females. The percentage levels given above were approximately equivalent to the administration of 0, 319, 128, 65, and 34 mg/kg/day Benax 281, respectively, over the two-year period.
Each dog was weighed weekly for the first three months of the experiment and twice a week thereafter. Food consumption was recorded 3 during the first , 12th, and 16th months, and one week out of each month from 18 months to the end of the experiment. Hematological studies and determinations of serum urea nitrogen content and alkaline phosphatase activity were made before the beginning of the experiment and at three, six, nine, 12, 18, and 24 months. Transaminase activity (SGPT) was determined at one and two years and bromsulfophthalein dye retention at one year. Urea nitrogen content and transaminase and alkaline phosphatase activity was determined. Pre-exposure liver biopsies were performed on one dog of each sex per level, as well as at six, 12, and 18 months on the experiment.
At the end of the two-year period the animals were fasted overnight and weighed before examination at autopsy. The lungs, heart, liver, kidney, spleen, testes, and brain were removed and weighed. Portions of each organ,as well as spinal cord, peripheral nerve, pituitary, thyroid, adrenal, aorta, lymph node, thymus, esophagus, stomach, small and large intestine, pancreas, urinary bladder, ovary, uterus, and skeletal muscle were preserved. The tissues were then sent to the International Research and Development Corporation in Mattawan, Michigan, for preparation of hematoxylin-eosin stained sections and microscopic examination. - Positive control:
- Non
- Observations and examinations performed and frequency:
- Each dog was weighed weekly for the first three months of the experiment and twice a week thereafter. Food consumption was recorded 3 during the first , 12th, and 16th months, and one week out of each month from 18 months to the end of the experiment.
- Sacrifice and pathology:
- Hematological studies and determinations of serum urea nitrogen content and alkaline phosphatase activity were made before the beginning of the experiment and at three, six, nine, 12, 18, and 24 months. Transaminase activity (SGPT) was determined at one and two years and bromsulfophthalein dye retention at one year. Urea nitrogen content and transaminase and alkaline phosphatase activity was determined. Pre-exposure liver biopsies were performed on one dog of each sex per level, as well as at six, 12, and 18 months on the experiment.
At the end of the two-year period the animals were fasted overnight and weighed before examination at autopsy. The lungs, heart, liver, kidney, spleen, testes, and brain were removed and weighed. Portions of each organ,as well as spinal cord, peripheral nerve, pituitary, thyroid, adrenal, aorta, lymph node, thymus, esophagus, stomach, small and large intestine, pancreas, urinary bladder, ovary, uterus, and skeletal muscle were preserved. The tissues were then sent to the International Research and Development Corporation in Mattawan, Michigan, for preparation of hematoxylin-eosin stained sections and microscopic examination. - Other examinations:
- None
- Statistics:
- No data
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Benax 2A1 was fed in the diets of male and female beagle hounds for a period of two years at the concentrations of 1.0, 0.5, 0.25, or 0.125%. Food consumption data indicated that the dietary concentrations given above administered the test substance in amounts of 319, 128, 65 and 34 mg/kg/day respectively. No evidence of adverse effect whatsoever was observed in the dogs given the 0.5% dietary level or below as judged by general appearance and behavior, growth, food consumption, hematological values, determinations of serum urea nitrogen content, alkaline phosphstase and transaminase activity, and bromsulfophthalein dye retention, final body and organ weights, and gross and microscopic examination of the tissue.
The two males and four females which received 1.0% Benax 2A1 in their diets showed growth retardation. Because male dog #330 and female dog #343 lost approximately one-third of their original weights, they were sacrificed after 14 months of the experiment. The final weight of the other male was essentially the same as his original weight, while two of the remaining females lost weight and the third gained. The 1.0% level was not readily acceptable to the dogs. Persistent scratching at the feeders was noted during the early months of the experimental period. This was noted to some extent also in the group of dogs receiving the 0.5% level. Food consumption records for the first month reflect this observation in that the unusually high figures in comparison with the controls was due to spillage and wastage. Therefore, it is possible that the growth retardation in the dogs maintained on the diet containing 1.0% Benax 2A1 may be related somewhat to decreased food intake, at least during the early part of the experiment. Intestinal irritation, as evidenced by loose stools and diarrhea which these dogs exhibited for the first 45 days on the experiment, also may have contributed to their failure to gain weight.
Alkaline phosphatase determinations at various intervals throughout the two-year period showed a slight increase in activity in both of the male dogs and in two of the four females on the 1.0% level. However, the determination of two other liver function tests, that of bromsulfophthalein dye retention at approximately one year and transaminase activity at one and two years, gave normal results in comparison with the control values.
An increased liver/body weight ratio was found in the male dog which was sacrificed after 14 months. The organ/body weight ratio of the kidney of the 1.0% male which was carried through to the end of the two-year period was also increased. However, these variations are due to decreased body weights, since there was no increase in the organ weights when considered on the absolute basis in grams.
Hematological values, serum urea nitrogen determinations, and gross and microscopic examination of the tissues gave no indication of any adverse effects in the dogs which received 1.0% Benax 2A1 in their diets when compared with the controls. - Dose descriptor:
- NOAEL
- Effect level:
- 128 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Based on growth retardation, loose stools and diarrhea, and increased alkaline phosphatase observed in dogs given 319 mg/kg/day or 1.0% in diet. Note: 128 mg/kg/day= 0.5% on diet.
- Critical effects observed:
- not specified
- Conclusions:
- The systemic NOEL in Beagle dogs was determined to be 0.5% or 128 mg DOWFAX 2A1/kg bw/day.
- Executive summary:
Male and female beagle hounds were maintained for two years on diets containing 0.5, 0.25, or 0.125% Benax/DOWFAX 2A1 (equivalent to 128, 65, and 34 mg/kg/day) without evidence of adverse effect as judged by general appearance and behavior, growth, food consumption, hematological values, determinations of serum urea nitrogen content, alkaline phosphatase and transaminase activity and bromsulfophthalein dye retention, final organ and body weights, and gross and microscopic examination of the tissues compared to control animals. At the highest dose level (1% or 319 mg/kg/day, study LOAEL), growth was retarded in the male and female dogs fed Benax/DOWFAX 2A1. These dogs also had loose stools and diarrhea for the first 45 days of the experiment; slightly increased alkaline phosphatase activity in both male dogs and in two out of four female dogs; variations in a few organ/body weight ratios with no difference in organ weights when considered on the absolute basis in grams. Hematological determinations, serum urea nitrogen and transaminase values, determination of bromsulfophthalein dye retention, and gross and microscopic examination of the tissues gave no indication of adverse effects when compared with the controls. Based on these effects, the systemic NOEL in Beagle dogs was determined to be 0.5% or 128 mg DOWFAX 2A1/kg bw/day.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 128 mg/kg bw/day
- Study duration:
- chronic
- Species:
- dog
- Quality of whole database:
- acceptable
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 adverse effect observed
Additional information
ORAL STUDIES OVERVIEW:
No repeat-dose studies are available on the registered substance. Data from ADPODS category members are available to satisfy this requirement and derive DNELs (see category document for justification). Chronic dietary dog study with DOWFAX 2A1 category member was used for DNEL deviation (Klimisch=2) as the two ADPODS category members (DOWFAX 3B2 and 2A1) differ only by length of two carbons of the alkyl side chain and thus are closest neighbors within the ADPODS category. In this key study, male and female beagle hounds were maintained for two years on diets containing 0, 34, 65, 128, 319 mg/kg/day DOWFAX 2A1. No evidence of adverse effect was evident at exposure concentrations of equal to or greater than 128 mg/kg/day as judged by general appearance and behavior, growth, food consumption, hematological values, determinations of serum urea nitrogen content, alkaline phosphatase and transaminase activity and bromsulfophthalein dye retention, final organ and body weights, and gross and microscopic examination of the tissues. Growth was decreased in the male and female dogs fed highest dose of 319 mg/kg/day DOWFAX 2A1 (study LOAEL). This test group also had loose stools and diarrhea for the first 45 days of the experiment; slightly increased alkaline phosphatase activity in males and half of females; and variations in a few relative organ/body weight ratios. Based on all these observations, the general systemic toxicity NOAEL (and point of departure for DNEL derivation) for this chronic dog study has been set at 128 mg/kg/day.
In the supporting chronic rodent study (Klimisch=2), groups of 30 male and female rats were maintained for a period of two years on diets containing 0, 15, 50, 150, 500 mg DOWFAX 2A1/kg bw/day without evidence of adverse effect as judged by general appearance and behavior, mortality, incidence of tumorous growths, food consumption, hematological studies, serum urea nitrogen and alkaline phosphatase determinations, bone marrow examination, final average body and organ weights, and gross and microscopic examination of the tissues. Study LOAEL was based on depressed growth and statistically significant decrease in the final average body weight at the end of two years seen in female rats fed 500 mg/kg/day DOWFAX 2A1; the general systemic toxicity NOAEL for this study was 150 mg/kg/day.
In a supporting subchronic rodent study (Klimisch=2), rats were administered 0, 0.01, 0.03, 0.1, 0.3 and 1.0 % DOWFAX 2A1 in the diet for 90 days. Livers of male rats at the 1% level showed central lobular necrosis of the parenchymal cells, and fatty degeneration and early, but slight fibrosis with some slight bile duct epithelium proliferation in the portal areas. At 1% dose level, females showed decreased growth together and similar histopathology to males, as well as statistically significant increase in the average liver and kidney weights. Based on the above findings the study NOAEL was 0.3% in the diet.
In another supporting subchronic study (Klimisch=2), dogs were administered 0, 40, 131 or 350 mg/kg/day DOWFAX 2A1 in the diet for 95 days. The dogs in the 350 mg/kg/day dose group dogs consumed 73% of the food quantity compared to the control group. The corresponding decrease in body gain weight and relative organ weights was proportional to the decrease in food consumption in comparison with the controls. However, there was no difference in absolute organ weights when compared with the controls. There was an increase in the serum alkaline phosphatase values in the highest intake group without accompanying pathological changes in the liver nor any significant difference in the liver/body weight ratio when compared with the controls. Based on the above findings the study NOAEL was 131 mg/kg/day.
In the 2003 GLP OECD422 screen with another category member (Klimisch=1), groups of 12 male and 12 female CD rats were administered DOWFAX 8390 surfactant 7 days/week, by gavage at dose levels of 0, 25, 75, and 250 mg/kg/day. Gavage administration of 250 mg DOWFAX 8390/kg/day resulted in increased incidences of soft/decreased feces (males only), accompanied by slightly increased prothrombin times (males only), increased serum ALT, and increased serum AST (females only) levels. At 75 mg/kg/day, prothrombin times were increased in males only. Urinalysis in the males revealed a slight increase in urine pH at all dose levels thought to be associated with the properties of the test material and/or its metabolites. There were no treatment-related effects on body weights, body weight gains, feed consumption, detailed clinical observations, neurological end points, reproductive/developmental end points, organ weights, or histopathology at any dose level tested. No toxicologically significant effects occurred in the 25 mg/kg/day group (systemic study NOAEL) following bolus administration of DOWFAX 8390.
In a supporting subchronic rodent study with DOWXAF 8390 (Klimisch=2), rats were given 0, 50, 100, 200 or 600 mg of substance daily in the diet for 90-91 days. Increased kidney weights accompanied by microscopic observations were observed only at the highest dose levels. The kidney morphology and function were not different from control rats at the two groups with lower material intake. The SGPT activity was increased at all dose levels in the male rats in the absence of any histological or other biochemical evidence of liver damage. No other alterations/effects were observed at any dose level. The subchronic study NOAEL was 200 mg/kg/day for rats.
In another supporting subchronic dog study with DOWXAF 8390 (Klimisch=2), dogs were given 0, 50, 100 or 200 mg/kg/day material in the diet for 90 days. Increased kidney and liver weights in male and female dogs, without associated histological alterations, were seen at the high dose level. Thus, no significant toxicological effects were observed among any of the groups of dogs administered DOWFAX 8390. The subchronic study NOAEL was 200 mg/kg/day for dogs.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: Longest repeat dose study with DOWFAX 2A1 category member of close alkyl chain length was chosen that also established the lowest study NOAEL within the dietary ADPODS dataset. All durations of exposure to this category of materials have showed similar effects in test animals.
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
Longest repeat dose study with DOWFAX 2A1 with lowest NOAEL. All
durations of exposure to test material showing similar effects in test
animals.
Justification for selection of repeated dose toxicity dermal -
systemic effects endpoint:
sufficient data available on the registered substance for assessment.
Justification for selection of repeated dose toxicity dermal - local
effects endpoint:
sufficient data available on the registered substance for assessment.
Repeated dose toxicity: via oral route - systemic effects (target
organ) digestive: liver; urogenital: kidneys
Justification for classification or non-classification
Non-classification for the registered substance (Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]) is based on the chronic NOAEL of 128 mg/kg/day of a category member in accordance with the CLP.
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