Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted method but limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
5 rats per dose group were observed for 14 days, clinical signs were recorded and LD50 values were calculated.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
yellow-brown colored flakes; test item: WTR7
Purity and stability/homogeneity not indicated

Test animals

Species:
rat
Strain:
other: albino
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Doses:
7.2, 8.6, 10.3, 12.4, 14.9 ml/kg bw; corresponds to 2.16, 2.58, 3.09, 3.72, 4.47 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 190 mg/kg bw
Based on:
test mat.
95% CL:
> 2 730 - < 3 720

Any other information on results incl. tables

Clinical signs as sluggishness was recorded to start 48 h after dosing; death occurred during the second to fourth day after treatment thereafter the animals recoverd. Macroscopic examiation of the survivors revealed white necrotic spots on the kidney of several rats.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an early study with limited documentation groups of 5 male and 5 female albino rats were dosed with TMQ in an acute oral toxicity experiment. Animals were dosed with 2160 to 4470 mg/kg and observed for 14 days. Clinical signs as sluggishness was recorded to start 48 h after dosing; death occurred during the second to fourth day after treatment. The calculated LD50 was 3190 mg/kg (95% CL 2730 -3720 mg/kg).