Registration Dossier
Registration Dossier
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EC number: 203-004-2 | CAS number: 102-08-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Acute toxicologic evaluation of diphenyl-thiourea
- Author:
- Bomhard E.
- Year:
- 1 996
- Bibliographic source:
- J Am Coll Toxicol., 1996; vol15 (suppl.1): S70.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Male and female rats were exposed to one only dose of DPTU (2000 mg/kg bw). Mortality and clinical signs were observed during 14 days.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,3-diphenyl-2-thiourea
- EC Number:
- 203-004-2
- EC Name:
- 1,3-diphenyl-2-thiourea
- Cas Number:
- 102-08-9
- Molecular formula:
- C13H12N2S
- IUPAC Name:
- 1,3-diphenyl-2-thiourea
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: around 185g (males) and around 170g (females)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- physiological saline
- Details on oral exposure:
- Volume administered: 10 ml/kg
Suspension in physiologic saline with the addition of 2% Cremophor EL. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The animals were observed for clinical signs, mortality, body weights and gross pathological changes.
Post dose observation period: 14 days - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: Apathy and piloerection were observed. Onset of these symptoms was about 30min after administration but by day 2, all animals were free of clinical signs.
- Gross pathology:
- no effects
- Other findings:
- NECROPSY FINDINGS: no abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality is observed at 2000 mg/kg bw. The acute oral LD50 for male and female rats is > 2000 mg/kg bw.
- Executive summary:
One group of 5 male and 5 female young adult rats (185/170 g) was dosed at 2000 mg/kg. The animals were observed for mortality, body weights, clinical signs and gross pathological changes through day 14.
No mortality was observed. Clinical signs included apathy and piloerection. Onset of symptoms was about 30 min post administration. By day 2, all animals were free of clinical signs. Final necropsy at day 14 revealed no abnormalities. The acute oral LD50 for male and female rats is > 2000 mg/kg bw.
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