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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA FR Vol.50, No. 188, September 27, 1985
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
purity and storage conditions are not reported
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc.,Wilmington, Massachusetts
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 175-224 g
- Fasting period before study: yes
- Housing:individually in stainless steel 1/2'' wire mesh cages, sized in accordance with the "Guide for the Care and Use of Laboratory Animals'' of the Institute of Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Harlan Teklad Lab Blox, ad libitum
- Water (e.g. ad libitum):no data
- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
800, 1250, 1600 and 2000 mg/kg bw
No. of animals per sex per dose:
10 (5♂ and 5♀)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: pharmacological and toxicological effects: at 1, 4 and 24 hours after dosing and once a day through 14 days; viability: once a day; body weight: d0, d7 and d14 or were found dead
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The method of Litchfield and Wilcoxon via Innovative programing Associates,LABCAT Module Version 4.22.

Results and discussion

Preliminary study:
Dose-range -finding: 3 groups of 2 rats (1♂ and 1♀ per group) fasted and administrated test article at the dose levels: 500, 2500 and 5000mg/kg bw, orally by gavage. 0/2 animal died at the 500mg/kg bw dose level; 2/2 animals died at both the 2500 and 5000mg/kg bw dose levels.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 861.9 mg/kg bw
Based on:
test mat.
95% CL:
1 383.5 - 2 505.7
Sex:
female
Dose descriptor:
LD50
Effect level:
1 591.4 mg/kg bw
Based on:
test mat.
95% CL:
1 283.5 - 1 973.3
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 716.2 mg/kg bw
Based on:
test mat.
95% CL:
1 446.5 - 2 036.1
Mortality:
0/10 animals died at both the 800 and the 1250mg/kg bw dose levels
5/10 animals died at the 1600 mg/kg bw dose level
7/10 animals died at the 2000 mg/kg bw dose level
Clinical signs:
decreased activity, abnormal gait, abnormal stance, prostration, diarrhea, lacrimation and dyspnea
Body weight:
normal weight gain has been observed
Gross pathology:
Necropsy of the animals dying on study revealed fluid-filled and distended intestines and stomachs and discolored lungs and intestines. No visible lesions were observed in any animal at terminal necropsy .

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 4 (H302) according to Regulation (EC) No 1272/2008
Conclusions:
Based on the results from the Acute Exposure Oral Toxicity in rats, the acute oral LD50 for males, females and combined sexes was determined to be 1861.9 (1383.5 - 2505.7) mg/kg bw, 1591.4 (1283.5 - 1973.3) mg/kg bw and 1716.2 (1446.5 - 2036.1) mg/kg bw, respectively.
Executive summary:

An acute oral toxicity study with TETA was carried out in Sprague Dawley rats. Groups of 5 rats per sex were treated per gavage at 800, 1250, 1600 or 2000 mg/kg bw and were observed for 14 days thereafter. Mortality was 0, 0, 50 and 70%, respectively. The acute oral LD50 for males, females and combined sexes was determined to be 1861.9 (1383.5 - 2505.7) mg/kg bw, 1591.4 (1283.5 - 1973.3) mg/kg bw and 1716.2 (1446.5 - 2036.1) mg/kg bw, respectively.