Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 292-588-2 | CAS number: 90640-67-8
Acute Toxicity: oral
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:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FR Vol.50, No. 188, September 27, 1985
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- purity and storage conditions are not reported
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- EC Number:
- 292-588-2
- EC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Cas Number:
- 90640-67-8
- Molecular formula:
- C6H18N4, C8H20N4
- IUPAC Name:
- Amines, polyethylenepoly-, triethylenetetramine fraction
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system 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:
- other: decreased activity, abnormal gait, abnormal stance, prostration, diarrhea, lacrimation and dyspnea
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
