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EC number: 700-879-7 | CAS number: 1379822-00-0
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-03-05 to 2013-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine
- EC Number:
- 700-879-7
- Cas Number:
- 1379822-00-0
- Molecular formula:
- NA: UVCB substance
- IUPAC Name:
- (3E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8-tetramethyl-1-(morpholin-4-yl)-7,10,14-trioxa-4-azaheptadec-3-en-16-ol; 4-[(3E,20E)-12-[(2-{2-[(E)-[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino]propoxy}propoxy)methyl]-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine; 4-[(3E,20E)-12-ethyl-2,2,5,8,16,19,22,22-octamethyl-23-(morpholin-4-yl)-7,10,14,17-tetraoxa-4,20-diazatricosa-3,20-dien-1-yl]morpholine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age of animals: Young adult rats, 8 weeks old in group 1 and 2
- Weight at study initiation: 196 - 200 g
- Fasting period before study: the day before treatment
- Housing: 3 animals/sex/cage
- Diet: ssniff® SM R/M-Z+H complete diet, ad libitum
- Water: tap water from watering bottles ad libitum
- Acclimation period: 5 days in first step and 6 days in second step
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 - 15 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): 12/12, artificial light, from 6 am. to 6 pm.
IN-LIFE DATES: From: 2013-03-05 To: 2013-03-21
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: common vehicle
- Lot/batch no.: 19T3
DOSAGE PREPARATION: Formulations were prepared just before the administration and stirred continuously during the treatment.
CLASS METHOD
- Rationale for the selection of the starting dose: No severe acute toxicity was expected. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2x 3 female animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, after the treatment and once per day for 14 days thereafter
- Frequency of weighing: on day 0 (shortly before the treatment), on day 7 and on day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All female rats in step 1 (2000 mg/kg bw dose) survived until the end of the 14-day observation period.
In step 2, one rat dosed at 2000 mg/kg bw SIKA Hardener MTJ died on the treatment day 2 hours after the treatment. The death might be a consequence of systemic toxic effect of the test item. - Clinical signs:
- other: In group 1 treated with 2000 mg/kg bw of the test item clinical signs of reaction comprised of decreased activity (14 cases of 57 observations), abnormal gait (6/57), ventral position (7/57), blood around the nose (5/57), piloerection (7/57), decreased gr
- Gross pathology:
- One rat treated with 2000 mg/kg bw dose of the test item spontaneously died during the study. Five animals treated with 2000 mg/kg bw dose of test item survived until the scheduled necropsy on Day 15.
Slight hydrometra was observed in two females of the group 1 and moderate hydrometra was found in one female of the same group. Hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals. - Other findings:
- not applicable
Any other information on results incl. tables
Summary of lethality
Groups |
Treatment |
Lethality |
|
Test item |
Dose (mg/kg bw) |
Females |
|
1 |
SIKA Hardener MTJ Step 1 |
2000 |
0/3 |
2 |
SIKA Hardener MTJ Step 2 |
2000 |
1/3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item SIKA Härter MTJ (SIKA Hardener MTJ) in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 2000 mg/kg bw).
- Executive summary:
- In this acute oral toxicity study, two groups of female rats (Crl(WI)Br) were given a single oral dose of the test item SIKA Hardener MTJ at a concentration of 2000 mg/kg bw. The starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Since only one animal died in the second step, no further testing was required. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the treatment day in died animal and on the 15th day after the treatment in survivor animals. Lethality, Clinical symptoms and Body weight: One of six animals treated with 2000 mg/kg bw SIKA Hardener MTJ died on the treatment day 2 hours after the treatment. In the first step, CNS - and emotion symptoms (decreased activity, vocalisation), decreased muscular tension (body-, abdominal-, grip- and limb tone, skin turgor) and disturbances of the autonomic functions (dyspnoea, piloerection, blood around the nose) and coordination (abnormal gait, ventral position) were observed in animals between treatment day and Day 1. In the second step, CNS - and emotion symptoms (decreased activity, tremor, closed eyes) and disturbance of the coordination (ventral position) were observed in animals on the treatment day between 30 min and 1 hour after the treatment. The body weight development was normal in all animals. Gross pathology: Altogether 1 animal died, and 5 animals were sacrificed as scheduled during the study. All organs of the animals treated with 2000 mg/kg bw dose proved to be free of treatment related gross pathological changes. The method used is not intended to allow for the calculation of a precise LD50 value. However, for this acute oral toxicity study with the test item SIKA Hardener MTJ in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 ≥ 2000 mg/kg bw).
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