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Toxicological information

Acute Toxicity: oral

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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:
1996
Bibliographic source:
J Am Coll Toxicol., 1996; vol15 (suppl.1): S70.
Reference Type:
study report
Title:
Unnamed
Year:
1992
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

Constituent 1
Chemical structure
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-diphenylthiourea
Test material form:
solid: particulate/powder

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:
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.
Body weight:
no effects
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.