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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity tests on 113 environmental chemicals.
Author:
Hasegawa R, Nakaji Y, Kurokawa Y and Tobe M.
Year:
1989
Bibliographic source:
Sci. Rep. Res. Inst. Tohoku Univ. C 36: 1-4 and 10-16

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Mice were exposed to ETU by a single oral administration. The LD50 was determined in males and females.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Other name = Ethylenethiourea (ETU)
purity = "highest purity available"
ETU was purchased from various commercial source or was contributed by cooperating chemical companies.

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Laboratory Animal Center (Hamamatsu, Japan)
- Age at study initiation: 5 weeks old
- Weight at study initiation: no data
- Fasting period before study: 15 hours before administration
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS : no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
olive oil
Details on oral exposure:
No data
Doses:
6 increasing dose levels were selected and tested to confirm both LDO and LD100 values.
No. of animals per sex per dose:
10 animals/dose
Control animals:
not specified
Details on study design:
Clinicals signs and symptoms were monitored during the experimental period. animals were given regular laboratory chow 6 hr after a single administration and the number of dead animals were counted until the 14th day. Anatomical examination was performed immediately after death or at terminal sacrifice on day 14.
Statistics:
The fifty percent of lethal dose (LD50) was calculed using the Litchfield and Wilcoxon method.

Results and discussion

Preliminary study:
no data
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
4 350 mg/kg bw
95% CL:
4 020 - 4 710
Sex:
male
Dose descriptor:
LD50
Effect level:
4 150 mg/kg bw
95% CL:
3 640 - 4 730
Mortality:
yes
Clinical signs:
Acute toxic symptoms observed were hypoactivity and tonic convulsion.
Body weight:
no data
Gross pathology:
no data
Other findings:
Changes in tissues were observed : atrophy of spleen and thymus.

Applicant's summary and conclusion

Conclusions:
LD50 for rats (male/female) were 4125/4350 mg/kg/day in this study.
Executive summary:

Mice were exposed to ETU by a single oral administration. The LD50 was determined in males and females. LD50 for rats (male/female) were 4125/4350 mg/kg/day in this study.