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EC number: 201-248-4 | CAS number: 80-08-0
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Oral developmental and perinatal/postnatal reproductive toxicity study in rats, including postnatal reproductive toxicity in rats with behavioral and functional evaluation. Pregnant females dosed daily throughout gestation and postpartum.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dapsone
- EC Number:
- 201-248-4
- EC Name:
- Dapsone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-sulfonyldianiline
- Test material form:
- solid
- Details on test material:
- Dapsone (16 tablets, 25 mg each)a was used to prepare the suspensions. The tablets were ground to powder using a mortar and pestle, and
then two suspensions were prepared.
Constituent 1
- Specific details on test material used for the study:
- USP Lot #01110D
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- Daily
- Duration of test:
- F0 animals were sacrificed on day 28 post partum
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 3 mg/kg bw/day
- Dose / conc.:
- 12 mg/kg bw/day
- Dose / conc.:
- 30 mg/kg bw/day
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Body weights, food consumption, clinical signs and duration of gestation. Gross necropsy following weaning.
Litter size, pup viability and nursing behaviour. - Fetal examinations:
- F1 animals were evaluated for performance in a water filled M maze for overt coordination, swimming ability, learning and memory.
F1 males were monitored for the age of preputial separation and F1 females were monitored for the age of vaginal opening.
F1 animals were observed for changes in mating behaviour. F1 males testes and epididymides were weighed. F1 females were exhamined for numbers of corpora lutea, implantation sites and viable fetuses. F2 fetuses were weighed and examined for gross external alterations.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One high dose female was found dead during lactation. No other unscheduled deaths.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significantly reduced in high dose group over the period of gestation. Mean body weight tended to be reduced in high dose females during the lactation perod.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Mirrored body weight effects.
- Food efficiency:
- 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
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Reduced mean implantations at 75 mg/kg/d.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean number of stillborn pups per litter was significantly higher with increased exposure to dapsone.
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12 mg/kg bw/day
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean number of stillborn pups per litter was significanty higher with increased exposure to dapsone but no effects were observed on pup viability post partum.
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Basis for effect level:
- other: No effects observed in the abscence of maternal toxicity
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Treatment of pregnant rats resulted in maternal toxicity, but not effects on physical or behavioural development were noted in the offspring.
All clinical signs were considered incidental, body weight gain was significantly reduced in high dose females and food consumption mirrored body weight observations.
There was no effect of treatment on the duration of the destation period, the number of rats that delivered or the number of dams with pups dying post partum. The number of stillborn pips per litter was increased but only in the presence of effects on maternal body weight and food consumption. No effects were noted on pup viability postpartum. - Executive summary:
An oral gavage developmental and perinatal/postnatal reproduction toxicity study in rats, including a postnatal behavioural/functional evaluation, was conduced in groups of 25 female rats with dose levels of 0, 3, 12 and 30 mg/kg/d. F0 females were administered the test articles daily from gestation day 7 (seventh day following confirmed mating) through day 27 postpartum. F0 animals were sacrificed on day 28 postpartum. 25 F1 animals of each gender (pups of F0 animals) were selected on day 28 postpartum. At approximately 90 days of age the F1 animals were cohabited for up to 21 days with an F1 animal of the opposite gender and from a different litter. F1 males were sacrificed at the conclusion of the cohabitation period. F1 females were sacrificed on gestation day 21 and c-sectioned.
Body weight, clinical signs and food consumption were monitored daily. F0 animals were monitored for duration of gestation, litter size, pup viability and nursing behaviour. Gross necropsy was performed. F1 animals were evaluated on approx. day 70 postpartum for performance in a water filled M maze for overt coordination, swimming ability, learning and memory. F1 males were monitored for the age of preputial separation and F1 females observed for age of vaginal opening. F1 animals were observed for changes in mating behaviour. Reproductive organs were weighed and F1 females were observed for numbers of corpora lutea, implantation sites and viable fetuses. F2 females were weighed and examined for gross external alterations.
Little toxicity was overserved under the conditions of the study, although mean body weight gain was significantly reduced in high-dose F0 females over the period of gestation, indicating that a sufficiently high level of exposure was achieved for the data to be valid. The mean number of stillborn pups was slightly but statistically significantly higher in high dose treatment groups than control. No effects were observed on pup viability, physical development, behaviour, learning ability or reproduction.
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