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EC number: 807-595-3 | CAS number: 6965-58-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- (2-methylpropanoyl)thiourea
- EC Number:
- 807-595-3
- Cas Number:
- 6965-58-8
- Molecular formula:
- C5H10N2OS
- IUPAC Name:
- (2-methylpropanoyl)thiourea
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material (as cited in study report): N-Isobutyrylthiourea
- Substance type: organic
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 9-12 weeks old
- Weight at study initiation: 156 - 210 g
- Fasting period before study:Prior to the administration food was withheld from the test animals for 18-19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
- Housing: The animals were kept individually groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102141114)
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1239)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- In order to get the test item in a solution or suspension, which is applicable to the animals, cottonseed oil (Sigma-Aldrich, lot MKBQ5465V, expiry date: 31 May 2015) was evaluated as vehicle and was found to be adequate.
Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.
For animals no. 1, 3 and 5, 1.75 mg of the test item were dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 1.75 mg/kg body weight at a dose volume of 10 mL/kg body weight.
For animals no. 2, 4 and 6, 5.50 mg of the test item were dissolved in the vehicle to gain a final volume of 10 mL and to achieve a dose of 5.50 mg/kg body weight at a dose volume of 10 mL/kg body weight.
The dose formulations were made shortly before each dosing occasion. - Doses:
- 1.75 and 5.50 mg/kg body weight
- No. of animals per sex per dose:
- 3 females (nulliparous and non-pregnant) per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: see any other information on materials and methods incl. tables
- Necropsy of survivors performed: yes
- Other examinations performed: see any other information on materials and methods incl. tables
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3.102 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1.75 - 5.5
- Mortality:
- All three out of three animals treated with the test item at a dose of 5.50 mg/kg body weight had to be sacrified for ethical reasons on the day of the treatment.
- Clinical signs:
- other: The most relevant clinical findings in the animals treated with the test item at a dose of 5.50 mg/kg bw were reduced spontaneous activity, piloerection, eyes half closed, bradykinesia, kyphosis, prone position, tachypnoea, abnormal breathing and ataxia.
- Gross pathology:
- Macroscopic findings of surviving animals: At necropsy, no macroscopic findings were observed in any animal.
Macroscopic findings of animals not having survived until the end of the observation period: Necropsy revealed liquid residues of the test item in abdominal cavity. - Other findings:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 based on GHS criteria
- Conclusions:
- Under the conditions of the present study the estimated LD50 of the test item N-Isobutyryl-thiourea in rats is 3.102 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study according to OECD 425 with N-Isobutyryl-thiourea all three animals treated with a dose of 5.50 mg/kg body weight had to be sacrified for ethical reasons on the day of treatment. The most relevant clinical findings in the animals treated with the test item at a dose of 5.50 mg/kg bw were reduced spontaneous activity, piloerection, eyes half closed, bradykinesia, kyphosis, prone position, tachypnoea, abnormal breathing and ataxia.
All three out of three animals treated with the test item at a dose of 1.75 mg/kg bw survived until the end of the study showing signs of toxicity. The most relevant clinical findings in the animals treated with the test item at a dose of 1.75 mg/kg bw were reduced spontaneous activity, piloerection and eyes half closed.
Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain.
Macroscopic findings of surviving animals:
At necropsy, no macroscopic findings were observed in any animal.
Macroscopic findings of animals not having survived until the end of the observation period:
Necropsy revealed liquid residues of the test item in abdominal cavity.
Therefore under the conditions of the present study the estimated LD50 of the test item N-Isobutyryl-thiourea in rats is 3.102 mg/kg body weight.
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