Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
After treatment the rats received stock diet and tap water as libitum.
They were observed for signs of intication during 14 day period, after which autopsies were carried out on the survivors.
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
Doses:
10.0 ml per kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No deaths occured
Clinical signs:
Within a few hours adter dosing the rats showed signs of sluggishness and decreased activity.
Later on the rats recovered and looked quite healthy during the remaining part of the observation period.
Macroscopic examination of the survivors at autopsy revealed no treatment related gross alterations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
From these results it appears that the LD60 of Sinodor 688 exceeds 10 ml per kg body weight.