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EC number: 205-286-2 | CAS number: 137-26-8
- 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:
- 5 Aug - 2 Oct 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- not specified
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- The room temperature was on various occasions, for a total of 18 hours, below the protocolled 19°C. This deviation was not considered to has affected the outcome of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- thiram
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO (CPB), Zeist, The Netherlands
- Age at study initiation: 11-14 weeks (male and female)
- Weight at study initiation: 243-359 g (male), 152-186 g (female)
- Fasting period before study: overnight before dosing till approximately 4 hours after administration of the test substance
- Housing: individually housed in Macrolon cages
- Diet: standard laboratory diet (RMH-B, pellet diameter 10 mm, Hope Farms, Woerden, The Netherlands), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 3-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 10 mL/kg bw - Doses:
- 560, 740, 1300, 2400, 4200 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 22 days
- Frequency of observations and weighing: daily for morbitidy, death and clinical signs (except for the day of dosing, were animals were observed 2, 6 and 7.5 h after dosing), animals were weighed on Day 0, 7, 14 and 21
- Necropsy of survivors performed: yes
- Histopathology: At the end of the observation period all surviving animals were scarified and subjected to gross necropsy. Found dead animals were weighed and subjected to gross necropsy.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 700 mg/kg bw
- 95% CL:
- 2.3 - 19.8
- Remarks on result:
- other: Maximum likelihood according to Finney
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 800 mg/kg bw
- Remarks on result:
- other: Maximum likelihood according to Finney
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 600 mg/kg bw
- Remarks on result:
- other: Maximum likelihood according to Finney
- Mortality:
- - 560 mg/kg bw: 0/5 males, 1/5 females (Day 1)
- 740 mg/kg bw: 0/5 males, 1/5 females (Day 2)
- 1300 mg/kg bw: 0/5 males, 0/5 females
- 2400 mg/kg bw: 0/5 males, 3/5 females (Day 9, 13 and 22)
- 4200 mg/kg bw: 4/5 males (Day 5, 6, 6 and 7), 5/5 females (Day 3, 7, 8 and 9)
Summarized results can be found in Attachment 1 in the attached background material. - Clinical signs:
- bodyweight loss
- diarrhoea
- lethargy (hypoactivity)
- salivation
- Body weight:
- greater than 10% body weight loss
- Remarks:
- Please refer to "Any other information on results incl. tables".
- Gross pathology:
- Please refer to "Any other information on results incl. tables".
Any other information on results incl. tables
Clinical Signs:
- 560 mg/kg bw: Lethargy, (half)-closed eyes, moist eyes reduced respiration in males and females from 1 h to Day 2 post-dosing. In addition, ungroomed appearance (on Day 2) and reduced faecal excretion (on Day 5) was noted in 1/5 females.
- 740 mg/kg bw: Lethargy, (half)-closed eyes, moist eyes, reduced respiration in males and females from 1 h to Day 2 post-dosing. In addition, ungroomed appearance (Day 2, and 8), reduced faecal excretion (Days 4 - 7), and emaciation (Days 6 - 9) was noted in some females.
- 1300 mg/kg bw: Lethargy, (half)-closed eyes, moist eyes, head tremors in males and females from 1 to 6 h post-dosing. In addition, emaciation and pale skin colour was noted in 1/5 females (Day 8).
- 2400 mg/kg bw: Lethargy was noted in all animals of both sexes from 1.5 to 5.5 h after dosing. Males showed lethargy also from day 4 to 7 and Day 12-13. Females shoed lethargy from Day 4 - 13, and Day 18 - 20. Rats of both sexes had closed eyes, moist eyes or salivation within 5.5 h post-dosing. Other signs consisting of bloody eye and nose encrustration, diarrhoea were observed in single animals on some days. In several females bloody eye and nose encrustration, tremors, emaciation, reduced respiration, comatous, ungroomed appearance and reduced faecal excretion were noted throughout the study period.
- 4200 mg/kg bw: Lethargy was noted in all animals of both sexes from 2 to 6 h after dosing, and from Day 4 (females) or Day 6 (males) until death of animals. Other signs, which were observed during the study were emaciation, ungroomed appearance, reduced or absent faecal excretion, pale skin colour, bloody nose or eyes encrustration, laboured breathing in animals of both sexes. Males showed also diarrhoe and tremors, whereas females had closed eyes.
Summarized results can be found in Attachment 1 in the attached background material.
Body weight:
- 560 mg/kg bw: All male and female animals gained weighed during the observation period. In the post-administration period Day 0 – 7, a small weight loss was observed (mean: males -2.7%, females -3.0%), but all animals recovered afterwards. (final mean body weight gain over the observation period: males +18.7%, females +14.3%)
- 740 mg/kg bw: All male and female animals gained weighed during the observation period. In the post-administration period Day 0 – 7, a small weight loss was observed (mean: males -6.5%, females -10.7%), but all animals recovered afterwards (final mean body weight gain over the observation period: males +18.5%, females +16.5%)
- 1300 mg/kg bw: All male and female animals gained weighed during the observation period. In the post-administration period Day 0 – 7, weight loss was observed (mean: males -7.9%, females -5.2%), but all animals recovered afterwards (final mean body weight gain over the observation period: males +12.5%, females +16.6%).
- 2400 mg/kg bw: All male animals gained weighed during the observation period. In the post-administration period Day 0 – 7, weight loss was observed (mean -16.7%), but all animals recovered afterwards (final mean body weight gain over the observation period: +14.7%). Females showed weight loss during the Day 0 – 7 observation period (mean -18.6%), and a partial recovery afterwards (final mean body weight gain over the observation period:-6.3%).
- 4200 mg/kg bw: Weight loss until deaths in all animals.
Summarized results can be found in Attachment 1 in the attached background material.
Pathology:
- 560 mg/kg bw: Autolysis of abdominal organs, yellow to white stomach content, and blood clots were observed in 1/5 females. In males no anomalies were observed.
- 740 mg/kg bw: Autolysis of abdominal organs, foamy white stomach content, blood clots in antral lumen were observed in one female. In males no anomalies
- 1300 mg/kg bw: No abnormalities in males and females were observed.
- 2400 mg/kg bw: Autolysis of abdominal organs, enlarged left adrenal, stomach erosive and containing small blood clots were observed in 1/5 females. In another female small spleen and ovaries, pale kidneys and intestine, no intestinal content, damaged stomach containing white granular substance. Histopathology evaluation of these lesions showed local pyelonephritis of kidney and focal erosion of the stomach. In males no anomalies
- 4200 mg/kg bw: In all males and females stomach findings consisting of white discoloration, petechiae, attachment to diaphragm, liver and spleen, white to grey discoloured thick fluid containing blood clots, erosion, speckled fibrosis, hyperemia, bloody stomach fluids, slightly thickened stomach, enlarged stomach, or bedding and mucous substance in stomach. Histopathological evaluation showed gastritis and local erosion, necrosis of the apical mucosa. 4/5 males and 2/5 females had duodenum findings consisting of perforations from 0.5 - 1 cm in length, necrotic areas, greenish mucous fluid with blood clots, or blood clots. Histopathology of one female revealed ulcus, and purulent inflammation in the distal end. Further findings in males were speckled liver lobes (local chronic inflammation with necrosis), testicular atropy (diffuse interstitial and tubular necrosis), and focal peripheral coagulation necrosis of liver, small focal haemorrhages of kidney cortex. In females kidney findings were vacuolisation of proximal tubular cells, increased protein presence in distal tubules and Bowmans space, cortical petechiae, dilatation of distal tubules, diffuse hypertrophy, glomerular necrosis. One female had also enlarged adrenals and a mucous substance in the intestine.
Summarized results can be found in Attachment 1 in the attached background material.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The study was conducted according to EPA-OPP 81-1 and under GLP conditions. Under the conditions of this study, the acute oral LD50 of thiram was 3700 mg/kg bw for males and 1800 mg/kg bw for female rats.
In accordance with Regulation (EC) No 1272/2008 the test susbtance should be classified as acute toxic category 4 and the hazard statement H302 “harmful if swallowed" should be assigned.
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