Registration Dossier
Registration Dossier
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EC number: 274-572-7 | CAS number: 70331-94-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No standard stated in the study report, however report is robust.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- EC Number:
- 274-572-7
- EC Name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Cas Number:
- 70331-94-1
- Molecular formula:
- C40H60N2O8
- IUPAC Name:
- (1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
- Test material form:
- not specified
- Details on test material:
- Referenced as TVCI within the report.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals: Sprague-Dawley male and female rats obtained from Charles River Breeding Laboratories.
Weight Range: At initiation, 127 – 260 grams.
Diet: Animals were fasted twenty-four hours prior to dosing. Immediately following dosing, the animals were given food; (Wayne Lab-Blox) and water, ad libitum.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- vegetable oil
- Details on oral exposure:
- A constant volume of 25 or 30 ml/kg was maintained using vegetable oil as a diluent.
- Doses:
- 10 gm/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- Mortality and Toxic Effects:
Following dosing, all animals were observed immediately and hourly for eight hours each day for 14 days.
Terminal Studies:
On day 14, post-administration, all animals were killed and a gross necropsy performed. - Statistics:
- None specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occured.
- Clinical signs:
- No changes noted.
- Body weight:
- No changes noted.
- Gross pathology:
- No visible compound-related lesions found.
- Other findings:
- None specified
Any other information on results incl. tables
Animal No. |
Sex |
Weight (grams) |
ml Admin. |
Observed Mortality |
Total Deaths |
||||||||||||||
Day |
|||||||||||||||||||
Initial |
Final |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||
1 |
M |
259 |
354 |
7.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0/10 |
2 |
M |
245 |
319 |
7.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 |
M |
248 |
319 |
7.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 |
M |
260 |
357 |
7.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5 |
M |
235 |
346 |
7.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
F |
153 |
213 |
4.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7 |
F |
150 |
211 |
4.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
F |
142 |
200 |
4.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9 |
F |
144 |
190 |
4.30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
F |
150 |
203 |
4.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Observation: No visible change
Necropsy Findings: No visible lesions
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 >10 gm/kg
- Executive summary:
A single administration was given to five male and five female Sprague-Dawley rats at a dose of 10 gm/kg. No mortality was seen in the rats.
LD50 >10 g/kg
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