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EC number: 201-286-1 | CAS number: 80-51-3
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with the OECD guideline 421, and in compliance with GLP standard.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-oxydi(benzenesulphonohydrazide)
- EC Number:
- 201-286-1
- EC Name:
- 4,4'-oxydi(benzenesulphonohydrazide)
- Cas Number:
- 80-51-3
- Molecular formula:
- C12H14N4O5S2
- IUPAC Name:
- 4-[4-(hydrazinesulfonyl)phenoxy]benzene-1-sulfonohydrazide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 4,4'-Oxybis(benzenesulfonyl hydrazide)
- Analytical purity: no data
- Purity test date: 99.3 wt%
- Lot/batch No.: 403650
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- no data
- Details on mating procedure:
- no data
- Duration of treatment / exposure:
- Male: total of 46 days beginning 14 days before mating
Female: From 14 days before mating to day 4 of lactation throughout the mating and pregnancy period - Frequency of treatment:
- daily
- Details on study schedule:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 3, 10, 30 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- no data
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All animals were observed twice a day
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded in males and females on days 1, 2, 5, 7, 10, and 14 of the administration during the pre-mating period. Thereafter, males were weighed on the days 21, 28, 35, 42, and 46 of the administration, and the day of necropsy. Females were weighed on days 0, 1, 3, 5, 7, 10, 14, 17, 20 of gestation and on day 0, 1, and 4 of lactation, and the day of necropsy (day 5 of lactation).
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Means of food consumptions were calculated for each rat per day.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OTHER:
CAGE SIDE OBSERVATIONS: Yes / No / No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations:
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 / 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): Yes / No / No data
- Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- Not examined
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities,
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
no data
GROSS NECROPSY
- Gross necropsy consisted of: At necropsy, all animals were macroscopically examined external condition.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following organs were weighted; brain, heart, liver, kidneys, adrenals, thymus, testes, epididymides, and ovaries.
The main organs of all animals were fixed in 10 % neutral buffered formalin. The testes and epididymides were fixed with Bouin’s solution and preserved in 70 % alcohol. The reproductive organs (ovaries, epididymides, and testes) in the control and highest dose groups were performed on histological examination. - Postmortem examinations (offspring):
- no data
- Statistics:
- Statistical analysis was performed using the one-way ANOVA and Kruskal-Wallis’s test. Dunnett’s test’s test and Mann-Whitney’s U test were used for post-hoc comparison. Statistical analysis of fetuses was carried out using the litter as an experimental unit.
- Reproductive indices:
- •Estrous cycle: normality (%), length (day)
•Copulation index (%) = (No. of pairs with successful copulation / No. of pairs mated) X 100
•Fertility index (%) = (No. of pregnant rats/No. of pairs with successful copulation) X 100
•Gestation index (%) = (No. of females with live pups / No. of pregnant females) X 100
•Gestation length (day)
•Nursing index (%) = (No of females nursing live pups on day 4 of lactation / No. of females with live pups delivery) X 100
•Implantation index (%) = (No. of implantations / No. of corpora lutea) X 100
•Delivery index (%) = (No. of pups born / No. of implantations) X 100 - Offspring viability indices:
- •Sex ratio of life pups = No. of male pups born / No. of female pups born
•Live birth index (%) = (No. of live pups on day 0 of lactation /No. of pups born) X 100
•Viability index on day 4 of lactation (%) = (No. of live pups on day 4 of lactation / No. of live pups on day 0 of lactation) X 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
no data
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Body weight gain and food consumption in all groups were not affected by the test article administration.
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
no data
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
No compound-related effects were observed in reproductive and developmental parameters.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
no data
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No compound-related effects were observed in reproductive and developmental parameters.
ORGAN WEIGHTS (PARENTAL ANIMALS)
The relative weight of the kidneys was significantly increased at 10 mg/kg bw/day. Significant increases in the absolute and relative weights of the kidneys in both sexes and in the relative weight of the liver in males were found at 30 mg/kg bw/day.
GROSS PATHOLOGY (PARENTAL ANIMALS)
no data
HISTOPATHOLOGY (PARENTAL ANIMALS)
There was no relevant change in comparison to the control.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on reproductive parameters (male/female) at highest tested dose level.
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on reproductive parameters (male/female) at highest tested dose level.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
No compound-related effects were observed in reproductive and developmental parameters.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on reproductive parameters (male/female) at highest tested dose level.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Treatment related:
- no
- Dose response relationship:
- no
Applicant's summary and conclusion
- Conclusions:
- The toxicity to reproduction of OBSH was evaluated in a reproduction/debelopmental toxicity screening test. The study was performed in accordance with the OECD guideline 421.
The NOEL for repeated dose toxicity in parents was considered to be 3 mg/kg bw/day, and the NOEL for reproductive and developmental toxicity was 30 mg/kg bw/day. - Executive summary:
The toxicity to reproduction of OBSH was evaluated in a reproduction/developmental toxicity screening test. OBSH was administered to rats by oral gavage at doses 0, 3, 10 or 30 mg/kg bw/day. The study was performed in accordance with the OECD guideline 421.
The NOEL for repeated dose toxicity in parents was considered to be 3 mg/kg bw/day, and the NOEL for reproductive and developmental toxicity was 30 mg/kg bw/day.
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