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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:
other: Study 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:
no guideline followed
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Stabilisator C, diphenylthioharnstoff
- Analytical purity: 99%

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
- Weight at study initiation: around 185g (males) and around 170g (females)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
physiological saline
Remarks:
Suspension in physiologic saline with the addition of 2% Cremophor EL
Details on oral exposure:
Volume administered: 10 ml/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
one group = 5 males + 5 females
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 data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: (no mortality)
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC 1272/2008 (CLP)
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 obiserved for mortality, body weights, clinical signs and gross pathological changes through day 14.

No mortality was observed. Clinical signs included aptathy and piloerection. Onset of symptoms was about 30 min porst 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.