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EC number: 219-350-2 | CAS number: 2422-88-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2017 - 28 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008 (including most recent amendments)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147
- Version / remarks:
- November 2000 (including most recent partial revisions)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tributyl-2-thiourea
- EC Number:
- 219-350-2
- EC Name:
- Tributyl-2-thiourea
- Cas Number:
- 2422-88-0
- Molecular formula:
- C13H28N2S
- IUPAC Name:
- 1,1,3-tributylthiourea
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tri butyl thiourea
- Appearance: Clear pale to medium brown liquid
- Storage conditions: At room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han) (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8-9 weeks old
- Weight at study initiation: 139 - 166 g
- Fasting period before study: yes
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages containing sterilized sawdust as bedding material and paper as cage-enrichment.
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): set to maintain 18 to 24°C
- Humidity (%): set to maintain 40 to 70%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: from: 30 January 2017 to: 28 February 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.12 mL/kg bw
DOSAGE PREPARATION (if unusual): The test item was kept at room temperature for a maximum of 4 hours prior to dosing and dosed undiluted (as delivered).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to OECD test guideline 423. - Doses:
- Dosing was performed in a stepwise manner, starting at a dose level of 2000 mg/kg body weight. The presence of mortality determined the lower dosing of 300 mg/kg body weight.
- No. of animals per sex per dose:
- 3 female animales per dosing group; 1 groups of females was exposed to 2000 mg/kg bw, 2 groups of 3 females were exposed to 300 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (mortality/viability): twice daily
- Frequency of weighing: day 1 (pre-administration), 8 and 15 and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. - Statistics:
- No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals treated at 2000 mg/kg were found dead on Day 2. No further mortality occurred in the treatment group of 300 mg/kg body weight.
- Clinical signs:
- At 2000 mg/kg, hunched posture, uncoordinated movements, slow breathing, piloerection, diarrhoea, salivation watery discharge from the eyes and/or ptosis were noted for the animals on Days 1 and/or 2.
At 300 mg/kg, hunched posture and piloerection were noted for all animals on Day 1. - Body weight:
- The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
- Gross pathology:
- At 2000 mg/kg, beginning autolysis was noted for the animals found dead at Day 2. This finding was considered not indicative of toxicity.
At 300 mg/kg, reddish discoloration of the thymus was noted for one animal. No further abnormalities were found at macroscopic post mortem examination of the animals.
Any other information on results incl. tables
The results were evaluated according to:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments).
- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of items and mixtures (including all amendments).
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- /Category 4 (labeled as H302) based on Regulation (EC) No 1272/2008
- Conclusions:
- In an acute toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 was established to be within the range of 300-2000 mg/kg body weight. Based on the results obtained in this study, Tri butyl thiourea should be classified as Category 4 based on GHS and Regulation (EC) No. 1272/2008 (labeled as H302: harmful if swallowed).
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