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EC number: 203-004-2 | CAS number: 102-08-9
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
No specific study on fertility is available on DPTU.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
DPTU was not teratogenic in rats in test conditions but embryolethal and fetotoxic at 100 and 200 mg/kg/d. The NOAEL for developmental toxicity is 50 mg/kg bw.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: From IFFA CREDO Breeding Laboratories (St Germain sur l'arbresle, France)
- Age at study initiation: no data
- Weight at study initiation: males = 350 g ; females = 200-220 g
- Fasting period before study: no data
- Housing: Bred females were individually housed in clear polycarbonate cages with hardwood shavings as bedding.
- Diet (e.g. ad libitum): UAR Alimentation Villemoisson, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 1 or 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- °C
- Humidity (%): 55 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): a light cycle from 7AM to 7 PM - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- - Total volume applied: 5 ml/kg body wt
- Control group: received the vehicle alone (20 animals) - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1M / 3 F
- Length of cohabitation: overnight
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from gestational days 6 to 20
- Frequency of treatment:
- daily, at approximately the same time each time
- Dose / conc.:
- 25 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 20 or 21 females
- Control animals:
- yes, concurrent vehicle
- Maternal examinations:
- - Maternal observations: daily, for evidence of treatment-related effects.
- Maternal body weight: recorded on day 0 and every 3 days from days 6 to 21 of gestation.
- Food consumption: recorded on days 6, 11, 16 and 21. - Ovaries and uterine content:
- - On day 21 of gestation, the females were killed by an intrapulmonary injection of T61.
- Examination of uterine content: The uterus were removed and weighed. The uterine horns were then opened and the numbers of implantation and resorption sites and of live and dead fetuses were recorded. - Fetal examinations:
- - Examination of fetuses: Live fetuses were removed, weighed, sexed, and examined for external anomalies including those of the oral cavity.
. Half of the viable fetuses from each litter were randomly selected, fixed in Bouin's solution, and examined microscopically as described by Barrow and Taylor for soft tissue anomalies.
. The remaining half of the fetuses were fixed in 70% ethanol and subsequently eviscerated, macerated in 1 % KOH, stained with Alizarin red S, and examined microscopically for skeletal anomalies. - Statistics:
- - Whenever possible, the data were presented as means ± SD.
- Implantation sites, live fetuses and various body weights were analyzed by the one-way analysis of variance, followed by Dunnett's test if differences were found.
- The frequency of nonsurviving implants, resorptions and anomalies among litters was evaluated with the Dixon-Massey test after an arc-sine-square root transformation.
- Rates of pregnancy and fetal sex ratio were analyzed using Fisher's exact test.
- Where applicable, least-squares analysis was carried out. The reported level of statistical significance was p < 0.05. - Indices:
- - absolute weight gain + gravide uterus weight
- pregnancy rate
- mean live fetuses per litter
- mean percentage of nonsurvviving implants per litter (resorption + dead fetuses)
- mean resorption sites per litter
- fetal sex ratio M:F
- mean fetal body weight per litt - Historical control data:
- yes
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs attributed to treatment and no deaths were observed among treated females, in any dosed group.
- Description (incidence and severity):
- n/a
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No significant effect on maternal body weight gain was noted in females given 25 or 50 mg/kg/day.
Maternal absolute weight gain was significantly decreased at 100 mg/kg/day compared to control. - 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
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increases in the mean percentage of nonsurviving implants and early embryonic resorptions were observed at 200 mg/kg/day (p < 0.05), concomitant with a non-significant decrease in the mean number of live fetuses per litter.
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- Pregnancy rates were equivalent across groups: around 90% in both treated and control groups.
- Details on maternal toxic effects:
Treatment did not alter significantly the mean numbers of implantation sites, at any dose.- Dose descriptor:
- NOAEL
- Effect level:
- > 200 mg/kg bw/day
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance induced a dose-related reduction in both male and female fetal weights which were significantly different from the control at 100 and 200 mg/kg/day (p < 0.05 and p < 0.01, respectively). Indeed, DPTU produced foetoxicity which characterized by significant decreases in fetal weight in a dose-related manner.
- Description (incidence and severity):
- n/a
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The male-to-female sex ratio was comparable across groups (around 1 in both treated and control groups).
- Changes in litter size and weights:
- effects observed, treatment-related
- Description (incidence and severity):
- n/a
- External malformations:
- not specified
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- no specific pattern of malformation was distinguished and the incidences of the skeletal variants were comparable to that of controls.
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- A treatment-related increase in the incidence of subcutaneous cranial hemorrhage occurred at 200 mg/kg/day.
Apart from hemorrhage, single occurrences of craniorachischisis and gastroschisis, omphalocele, anophthalmia or microphthalmia, and diaphragmatic hernia were observed in treated groups. - Dose descriptor:
- NOAEL
- Remarks:
- (fetotoxicity)
- Effect level:
- 50 mg/kg bw/day
- Basis for effect level:
- reduction in number of live offspring
- Dose descriptor:
- NOAEL
- Remarks:
- (embryotoxicity)
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- fetal/pup body weight changes
- Dose descriptor:
- NOAEL
- Remarks:
- (teratogenicity)
- Effect level:
- > 200 mg/kg bw/day
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- DPTU was not teratogenic in rats in test conditions but embryolethal and fetotoxic at the doses of 100 and 200 mg/kg bw /day in absence of maternotoxicity.
The NOAEL for developmental toxicity is 50 mg/kg bw. - Executive summary:
Groups of 20 female rats were exposed at 0, 25, 50, 100 and 200 mg/kg of DPTU by gavage from Days 6 to 20 of gestation.
No clinical signs attributed to treatment and no deaths were observed among treated females, in any dosed group. No significant effect on maternal body weight gain was noted in females given 25 or 50 mg/kg/day. Maternal absolute weight gain was significantly decreased at 100 mg/kg/day compared to control. The NOAEL for maternal effet is 200 mg/kg bw because no major effect was observed at any dose.
The male-to-female sex ratio was comparable across groups (around 1 in both treated and control groups).
Treatment did not alter significantly the mean numbers of implantation sites, at any dose. Significant increases in the mean percentage of nonsurviving implants and early embryonic resorptions were observed at 200 mg/kg/day (p < 0.05), concomitant with a nonsignificant decrease in the mean number of live fetuses per litter. Test substance induced a dose-related reduction in both male and female fetal weights which were significantly different from the control at 100 and 200 mg/kg/day (p < 0.05 and p < 0.01, respectively). Therefore the NOAEL for foetoxicity effects is 50 mg/kg bw.
Moreover, embryofetal malformations were observed in the treated groups. A treatment-related increase in the incidence of subcutaneous cranial hemorrhage occurred at 200 mg/kg/day. Apart from hemorrhage, single occurrences of craniorachischisis and gastroschisis, omphalocele, anophthalmia or microphthalmia, and diaphragmatic hernia were observed in treated groups. However no specific pattern of malformation was distinguished and the incidences of the skeletal variants were comparable to that of controls.
No sign of teratogenicity was observed in this study (NOAEL for teratogenicity > 200 mg/kg bw).
To sum up, DPTU was not teratogenic in rats in test conditions but embryolethal and fetotoxic. The NOAEL for developmental toxicity is 50 mg/kg bw.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The Saillenfait study is a reliable study with a klimisch score of 1.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Developmental study of Saillenfait (1991):
Groups of 20 female rats were exposed at 0, 25, 50, 100 and 200 mg/kg of DPTU by gavage from Days 6 to 20 of gestation.
Toxic effects on females and foetus were observed.
No clinical signs attributed to treatment and no deaths were observed among treated females, in any dosed group. No significant effect on maternal body weight gain was noted in females given 25 or 50 mg/kg/day. Maternal absolute weight gain was significantly decreased at 100 mg/kg/day compared to control. The NOAEL for maternal effect is 200 mg/kg bw because no major effect was observed at any dose.
The male-to-female sex ratio was comparable across groups (around 1 in both treated and control groups).
Treatment did not alter significantly the mean numbers of implantation sites, at any dose. Significant increases in the mean percentage of nonsurviving implants and early embryonic resorptions were observed at 200 mg/kg/day (p < 0.05), concomitant with a nonsignificant decrease in the mean number of live fetuses per litter. Test substance induced a dose-related reduction in both male and female fetal weights which were significantly different from the control at 100 and 200 mg/kg/day (p < 0.05 and p < 0.01, respectively). Therefore the NOAEL for foetoxicity effects is 50 mg/kg bw.
Moreover, embryofetal malformations were observed in the treated groups. A treatment-related increase in the incidence of subcutaneous cranial hemorrhage occurred at 200 mg/kg/day. Apart from hemorrhage, single occurrences of craniorachischisis and gastroschisis, omphalocele, anophthalmia or microphthalmia, and diaphragmatic hernia were observed in treated groups. However no specific pattern of malformation was distinguished and the incidences of the skeletal variants were comparable to that of controls.
No sign of teratogenicity was observed in this study (NOAEL for teratogenicity > 200 mg/kg bw).
To sum up, DPTU was not teratogenic in rats in test conditions but embryolethal and fetotoxic. The NOAEL for developmental toxicity is 50 mg/kg bw.
Justification for classification or non-classification
Based on the developemental study in rats, DPTU should be classified as Repro. Cat 2 - H361d as "Suspected of damaging the unborn child" according to the Regulation EU n°1272/2008.
Justification : No sign of teratogenicity was observed in the rat study so the Repro Category 1 is not required. However, embryolethal and fetotoxic effects were observed at 100 mg/kg/day in absence of adverse maternal toxicity.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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