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EC number: 939-651-9 | CAS number: 1474044-70-6
- 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
No data on repeated dose toxicity with SDIBP is available. Therefore in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read across to sodium xylene sulphonate (CAS No. 1300-72-7), for repeated dose toxicity was performed. The 90-day rat oral study, conducted in 1969, is generally comparable to the OECD 408 guideline study and included the following observations: clinical signs, survival, body weight, feed consumption, gross pathology and non-neoplastic histopathology. The NOAEL was 763 mg a.i. per kilogram body weight per day based on loss of relative weight of the spleen. The 90-day dermal study was a guideline study with mouse (OECD 411) published by the US National Institutes of Health. The NOAEL for females is 540 mg a.i./kg bw / day and the NOAEL for males is 440 mg a.i./kg bw /day based on epidermal hyperplasia.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1968
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline not specified, but with detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no functional observations or ophthalmoscopy
- Principles of method if other than guideline:
- Groups of 30 young rats (15 males and 15 females) were exposed by diet for 90 days to three concentrations. A control group was included. Observations were made of behavior, appearance, growth, food and water intake and a number of haematological factors. At the end of the experiment (during week 14) ten organs of each surviving rat were weighed and examined histologically for pathological changes. Liver enxyme activities were also determined.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIVO-colony
- Age at study initiation: newly weaned
- Weight at study initiation: 41-60 g
- Fasting period before study: no data
- Housing: metal wire screen cages (5 to a cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 degrees centigrade
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: To: no data - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: test chemical mixed directly with stock diet
DIET PREPARATION
- Rate of preparation of diet (frequency): once a fortnight
- Mixing appropriate amounts with (Type of food): stock diet consisting of 28% yellow maize, 26% whole wheat, 10% rolled oats, 10% soybean oil meal, 8% fish meal and <5% each of meat scraps, dried whey, soybean oil, grass meal, minerals, sodium chloride and vitamin preparation.
- Storage temperature of food: room temperature
VEHICLE
- Justification for use and choice of vehicle (if other than water): no vehicle - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks / 90 days
- Frequency of treatment:
- in ad libitum diet
- Remarks:
- Doses / Concentrations:
0.2%, 1.0% and 5.0%
Basis:
nominal in diet - No. of animals per sex per dose:
- 15
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: previous range finding test
- Rationale for animal assignment (if not random): according to body weight - Positive control:
- none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Observations: general appearance and behaviour
- Time schedule: no data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly for the first week only
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 6 and week 12
- Anaesthetic used for blood collection: No data
- Animals fasted: No
- How many animals: 10 males and 10 females from each dose group
- Parameters checked in table [No.4] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: terminally
- Animals fasted: No data
- How many animals: 10 males and 10 females from each dose group
- Parameters checked in table [No.5 and No.6] were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: urinalysis from pooled samples from 10 males and 10 females from each dose group in 7th week.
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.7 and No.8] were examined.
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: kidney funcion from samples of 10 males and 10 females in 13th week. Serum protein electrophoresis of 10 males and 10 females of control and high dose groups at 13 weeks. Liver enzyme activity at termination. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- > 763 - < 3 534 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Critical effects observed:
- not specified
- Conclusions:
- Test compound possesses a very low order of toxicity. 1% in the diet (corrresponding to a daily intake of 763 mg a.i./kg bw) was a no toxic effect level. At 5% in the diet (corresponding to 4092 mg a.i./kg bw) there were slight indications of deleterious effecs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 763 mg/kg bw/day
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- February 23 - May 26, 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Protocols and results reviewed and accepted by the National Toxicology Program's Board of Scientific Counselor's Technical Reports Review Subcommittee, USA National Institutes of Health. The study was used as dose finding study for a carcinogenicity study and therefore the number of endpoints was limited.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- clinical signs reported weekly; no food consumption; no ophthalmoscopy, no clinical chemisty; no haematology
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: 7 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 1 animal per cage; polycarbonate cages and stainless steel racks (rotated every 2 weeks), with heat-treatted hardwood chip bedding and spun-bonded polyester cage filters changed every week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 to 23.9
- Humidity (%): 15 to 63
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: February 23 To: May 26, 1988 - Type of coverage:
- not specified
- Vehicle:
- ethanol
- Details on exposure:
- TEST SITE
- Area of exposure: clipped interscapular skin
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: once at start of study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 microliters
- Concentration (if solution): 0, 5, 15, 44, 133 and 400 mg/mL
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): ethanol, because in water alone the test substance beaded up
- Amount(s) applied (volume or weight with unit): 100 microliters of 50% ethanol and 50% distilled water
- Concentration (if solution): 50%
- Lot/batch no. (if required): no data
- Purity: no data
USE OF RESTRAINERS FOR PREVENTING INGESTION: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC verification of each dose at beginning, midpoint and end of study
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days per week
- Remarks:
- Doses / Concentrations:
17, 50, 140, 440 and 1300 mg active ingredient/kg bw for males and 20, 60, 170, 540 and 1620 mg active ingredient/kg bw for females
Basis:
analytical per unit body weight - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: wide range for screening study
- Rationale for animal assignment (if not random): random - Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations were not included in the report.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Kaplan and Meier
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- 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:
- not examined
- 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:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY - no treatment related effects
BODY WEIGHT AND WEIGHT GAIN - slight increase in body weight of males at highest dose
ORGAN WEIGHTS - increase in kidney weight of males but not dose dependent
GROSS PATHOLOGY - no treatment related effects
OTHER FINDINGS - epidermal hyperplasia of application site in males and females at the highest dose - Dose descriptor:
- NOAEL
- Effect level:
- >= 440 mg/kg bw (total dose)
- Sex:
- male
- Basis for effect level:
- other: overall effects other: epidermal hyperplasia (also seen in females at highest dose)
- Critical effects observed:
- not specified
- Conclusions:
- NOAEL = 440 mg a.i./kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 440 mg/kg bw/day
Additional information
There is no data available on repeated dose toxicity with SDIBP. A read-across was performed from sodium xylene sulphonate (CAS No. 1300-72-7), in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5.
The 90-day oral study is generally comparable to the OECD 408 guideline study (Huntsman, 1969). In that study, the highest dose for female rats - 4092 mg active ingredient (a.i.) per kilogram body weight per day - resulted in a loss in relative weight of the spleen. The 2nd highest dose for females - 763 mg a.i. per kilogram body weight per day- had no measureable adverse effects and therefore establishes the repeat dose oral NOAEL for the test substance. The highest oral dose for male rats - 3534 mg a.i. per kilogram body weight - had no measurable adverse effects. No adverse effects were reported in the 90 day rat study. Test compound possesses a very low order of toxicity. 1% in the diet (corrresponding to a daily intake of 763 mg a.i./kg bw) was a no toxic effect level. At 5% in the diet (corresponding to 4092 mg a.i./kg bw) there were slight indications of deleterious effecs. The overall effects were determined as hematology (decreased red blood cells; decreased activity of a transaminase in serum); urinalysis (decreased specific gravity of urine); organ weights (decreased spleen weight); histopathology (minimal changes in the liver).
The dermal repeated dose study was a guideline study (similar to OECD 411) published by the US National Institutes of Health, 1998a. This 90-day dermal study is a mouse study where the highest doses for males (1300 mg active ingredient per kilogram body weight per day) and the highest dose for females (1620 mg a.i./kg bw /day) resulted in epidermal hyperplasia. No other adverse effects were observed. The NOAEL for females is 540 mg a.i./kg bw /day and the NOAEL for males is 440 mg a.i./kg bw /day which is therefore the repeat dose dermal NOAEL for the test substance. No adverse effects were reported in the 90 day mouse study.
The two important routes of exposure have been addressed. Hence no need for an inhalation repeated dose.
Category Justification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances.
Applying the category approach read-across concept to SDIBP, data will be used from a representative member of the hydrotropes category to avoid unnecessary (animal) testing. The endpoints for which the read-across approach to SDIBP is applied, are: toxicokinetics, short-term toxicity to fish, toxicity to microorganism, acute toxicity (inhalation and dermal), skin irritation/corrosivity, skin sensitisation, genetic toxicity (in vitro, in vivo), repeated-dose toxicity (oral and dermal), screening for carcinogenicity, and screening for reproductive / developmental toxicity.
Hazard assessment related key information for SDIBP:
SDIPB and the hydrotrope members exhibit similar levels of low toxicity. Acute toxicity values are above the classification limits, they are not sensitizing and show no genotoxic effects. Both exhibit neglible irritation to the skin, but are moderately irritating to the eyes (Cat 2B). Together with the chemical structure similarity and their similar chemical properties, it is deemed correct to fill the existing data gaps on mammalian toxicity of SDIPB with the data of the hydrotrope category.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: spleen
Repeated dose toxicity: dermal - systemic effects (target organ) other: skin
Justification for classification or non-classification
No classification is warranted for the repeated dose toxicity as indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
Value used for CSA (route: oral): NOAEL 763 mg/kg bw/day
Target organs: cardiovascular / hematological: spleen
Value used for CSA (route: dermal): NOAEL 440 mg/kg bw/day
Target organs: other: skin
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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