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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed according to following guidelines:OECD 401, EPA Federal Register Vol.50, No. 188 , (September 27, 1985) and in compliance with the GLP Regulations. No significant deviations can be observed from the study guidelines, which could have an impact on the performed study. Well-documented; however, no data on purity were given.

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:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 6933-6-20
- Physical state: clear yellow liquid
- Analytical purity: not given
- Lot/batch No.: 92-014
- Stability under test conditions: no apparent change in the physical state of the rest article during storage or administration
- Storage condition of test material: no data
- Other: specific gravity=0.98g/ml;

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


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
800, 1250, 1600 and 2000 mg/kg
No. of animals per sex per dose:
10 (5♂ and 5♀)
Control animals:
other: not required according to OECD 401
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, other:
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, orally by gavage. 0/2 animal died at the 500mg/kg dose level; 2/2 animals died at both the 2500 and 5000mg/kg dose levels.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 861.9 mg/kg bw
95% CL:
1 383.5 - 2 505.7
Sex:
female
Dose descriptor:
LD50
Effect level:
1 591.4 mg/kg bw
95% CL:
1 283.5 - 1 973.3
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 716.2 mg/kg bw
95% CL:
1 446.5 - 2 036.1
Mortality:
0/10 animals died at both the 800 and the 1250mg/kg dose levels
5/10 animals died at the 1600 mg/kg dose level
7/10 animals died at the 2000 mg/kg 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:
Category 4 based on GHS criteria
Remarks:
Migrated information
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, 1591.4 (1283.5 - 1973.3) mg/kg and 1716.2 (1446.5 - 2036.1) mg/kg, 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 therafter. 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, 1591.4 (1283.5 - 1973.3) mg/kg and 1716.2 (1446.5 - 2036.1) mg/kg, respectively.