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Diss Factsheets
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EC number: 235-834-6 | CAS number: 13001-38-2
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Human & Environmental Risk Assessment on ingredients of European household cleaning products .
- Author:
- HERA risk assessments
- Year:
- 2 003
- Bibliographic source:
- HERA targeted risk assessment . May, 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study of test material was performed on rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- EC Number:
- 248-421-0
- EC Name:
- Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
- Cas Number:
- 27344-41-8
- Molecular formula:
- C28H22O6S2.2Na
- IUPAC Name:
- 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonic) acid
- Details on test material:
- - Name of test material (IUPAC name): 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonic) acid
- Common name: 4,4'-Bis(2-sulfostyryl)biphenyl
- Molecular formula: C28H20Na2O6S2
- Molecular weight: 562.572 g/mol
- Smiles notation: c1(c2ccc(\C=C/c3c(cccc3)S(=O)(=O)[O-])cc2)ccc(\C=C/c2c(cccc2)S(=O)(=O)[O-])cc1.[Na+].[Na+]
- InChl: 1S/C28H22O6S2.2Na/c29-35(30,31)27-7-3-1-5-25(27)19-13-21-9-15-23(16-10-21)24-17-11-22(12-18-24)14-20-26-6-2-4-8-28(26)36(32,33)34;;/h1-20H,(H,29,30,31)(H,32,33,34);;/q;2*+1/p-2/b19-13-,20-14-;;
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- No data available
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAI f (SPF) hybrid
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:9 weeks
- Weight at study initiation:
- Fasting period before study: Females were caged individually in Macrolon cages containing standardized soft wood bedding material.
- Housing:
- Diet (e.g. ad libitum): standard pelleted rat food (Nafag No. 890; Gossau, Switzerland) ad libitum
- Water (e.g. ad libitum):water ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%):30-70%,
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): daily cycle of 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous solution of carboxymethylcellulose (0.5% w/w).
- Details on exposure:
- Details on exposure
Test material dissolved in aqueous solution of carboxymethylcellulose (0.5% w/w).
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test material dissolved in aqueous solution of carboxymethylcellulose (0.5% w/w).
- Concentration in vehicle:0,1000mg/kg bw/day
- Amount of vehicle (if gavage): 20ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage:one male rat was housed with 3 females
- Length of cohabitation: No data available
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy:vaginal lavage showed spermatozoa or a vaginal plug was observed; this was designated as gestation day zero
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: [no / yes (explain)]No data available
- After successful mating each pregnant female was caged (how): an individual
- Any other deviations from standard protocol:No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days (6 through day 15 of gestation)
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 1000mg/kg bw/day
- No. of animals per sex per dose:
- Total :48
0 mg/kg :24 female
1000mg/kg:24 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- SACRIFICE
All animals survived to necropsy on gestation day 21
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGTHS
About one-half of each litter was taken for visceral evaluation by the Wilson slicing technique after fixation. The remaining fetuses from each litter were fixed, cleared with KOH solution and then treated with alizarin red S for examination of skeletal features. - Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no remarkable cage-side observations during the study.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival of treated rats were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of treated rats was observed as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated rats was observed as compared to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- All animals survived to necropsy on gestation day 21, except for one dam from the treated group, found dead on gestation day 15. Necropsy revealed no pathological findings. Necropsy of all other animals did not reveal adverse effects or abnormal findings
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- 2.The number of implantation sites and preimplantation losses were comparable in the two groups. Early resorption rate was not affected by treatment, and there were no late resorptions, abortions or dead fetuses. Thus, the number of viable fetuses was comparable in the two groups. Statistical analysis of these endpoints did not show significant differences from the control group.
There was no evidence for an impairment of reproductive functions in animals
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- histopathology: non-neoplastic
- reproductive performance
- Remarks on result:
- other: No effects on reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- body weights were not affected by treatment.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- The findings observed during fetal examinations were of equal frequency in the control and treated groups; thus, treatment-related effects on fetal external, visceral, or skeletal development did not occur in this study.
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Fetal sex ratios were not affected by treatment.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: No developmental toxic effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In reproductive and developmental toxicity study , NOAEL was considered to be 1000mg/kg bw/day as no effects on reproductive and developmental parameters were observed . When female rats were treated wtih test material orally.
- Executive summary:
In reproductive and developmental toxicity study , femaleTif:RAI f (SPF) hybrid ratsrats were treated wtih test material in dose concentration 0,1000mg/kg orallyfrom day 6 through day 15 of gestation, inclusive.Test materialwas administered by gavage in an aqueous solution of carboxymethylcellulose (0.5% w/w). The control group received the vehicle solution. The dose volume in both groups was 20 ml/kg body weight, based on the daily body weight.24 females in each group, a proven fertile male rat of the same strain was placed in a mating cage with 3 females each. The female was removed and indicated as pregnant if vaginal lavage showed spermatozoa or a vaginal plug was observed; this was designated as gestation day zero.All the animals observed for body weight ,food consumption and mortality. There were no remarkable cage-side observations during the study. Maternal body weights and food consumption were not affected by treatment. All animals survived to necropsy on gestation day 21, except for one dam from the treated group, found dead on gestation day 15. Necropsy revealed no pathological findings. Necropsy of all other animals did not reveal adverse effects or abnormal findings.Three animals in the control group were not pregnant, and one in the treated group died on gestation day15. Thus, the number of pregnant animals with viable fetuses at necropsy was 21 and 23 for the control and treated group, respectively.
The number of implantation sites and preimplantation losses were comparable with the control groups. Early resorption rate was not affected by treatment, and there were no late resorptions, abortions or dead fetuses. Thus, the number of viable fetuses was comparable with control groups. Statistical analysis of these endpoints did not show significant differences from the control group.Fetal sex ratios and body weights were not affected by treatment. The findings observed during fetal examinations were of equal frequency in the control and treated groups; thus, treatment-related effects on fetal external, visceral, or skeletal development did not occur in this study.Hence,NOAEL was considered to be 1000mg/kg bw/day as no effects on reproductive and developmental parameters were observed. When female rats were treated wtih test material orally
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