Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Test method details not published

Data source

Reference
Reference Type:
publication
Title:
Toxicologic characteristics of thiourea and its dioxide
Author:
Zhislin LE, Ovetskaia NM
Year:
1972
Bibliographic source:
Gig Tr Prof Zabol. 1972, Jun; 16(6) 51-52 (russ.) (Gigiena truda i professional'nye zabolevaniia] Toxline citation: http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~d3hGJg:3

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The author' own guideline
Principles of method if other than guideline:
LD50 was determined by intraperitoneal injection to white rats of aqueous solutions of the substances by probit analysis and in modification by V.B. Prozorovskiy when observed during 14 days. To characterize the cumulative properties of the two groups of rats 10 in each every day for 20 days, 1/5 LD50 thiourea (TU) and thiourea dioxide (TUD) was injected intraperitoneally (688.5 and 84.6 mg / kg, respectively). According to the formula proposed by S. Cherkinsky et al., accumulation factor was assessed. On 21 day, the surviving animals were introduced TU and TUD at a dose of LD50, and the death was recorded within 2 weeks.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
LD50was determined by intraperitoneal injection to white rats of aqueous solutions of the substances by probit analysis and in modification by V.B. Prozorovskiy when observed during 14 days. To characterize the cumulative properties of the two groups of rats 10 in each every day for 20 days, 1/5 LD50TU and TUD was injected intraperitoneally (688.5 and 84.6 mg / kg, respectively). According to the formula proposed by S. Cherkinsky et al., accumulation factor was assessed. On 21 day, the surviving animals were introduced TU and TUD at a dose of LD50, and the death was recorded within 2 weeks.
Doses:
84.6 mg/kg bw
No. of animals per sex per dose:
Female+male: 10
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
>= 418.6 - <= 437.7 mg/kg bw
Based on:
not specified
Mortality:
The repeated introduction of Thiourea (TU) developed reduced sensitivity to the substance: subsequent introduction of LD50 caused the death of a single animal.
Clinical signs:
no data
Body weight:
The repeated introduction of thiourea dioxide (TUD) resulted in weight loss much larger than during the introduction of thiourea (TU); the relative weight of most of the internal organs, in contrast, was higher.
Gross pathology:
no data

Applicant's summary and conclusion

Conclusions:
In single intraperitoneal introduction, thiourea dioxide (TUD) LD50 is 423 ± 14,7 mg / kg, thiourea (TU) is 3442 ± 103,2 mg / kg. The accumulation coefficient of TUD is 1.83 (expressed).
Executive summary:

Single intraperitoneal introduction of an aqueous solution of thiourea dioxide (tautomer of formamidine sulfinic acid) revealed a LD50 of 423±14.7 mg/kg,