Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Specific details on test material used for the study:
Identification: TMP-Ketal
Description: clear colourless liquid
Bach number: DEG 1003554

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
No. of animals per sex per dose:
One rat treated at dose of 300 mg/kg bw
Five rats treated at dose of 2000 mg/kg bw

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No effect
Clinical signs:
No effect
Body weight:
The treated animals exhibited expected body weight gain within the observation period of 14 days.
Gross pathology:
No effect

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral toxicity of TMP Ketal in rats was investigated according to the Guideline OECD 420. No effect was found at dose of 2000 mg/kg bw. The LD50 > 2000 mg/kg bw was obtained.
Executive summary:

The acute oral toxicity of TMP Ketal in rats was investigated according to the Guideline OECD 420. No effect was found at dose of 2000 mg/kg bw. The LD50 > 2000 mg/kg bw was obtained.