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EC number: 603-303-1 | CAS number: 128819-84-1
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 - 26 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- / no justification for exceptional limit dose of 5000 mg/kg bw provided
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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 Dec 2001
- Deviations:
- yes
- Remarks:
- / no justification for exceptional limit dose of 5000 mg/kg bw provided
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- yes
- Remarks:
- / no justification for exceptional limit dose of 5000 mg/kg bw provided
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI, Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Budapest, Hungary
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of trimethylolpropane triglycidyl ether and acrylic acid
- EC Number:
- 603-303-1
- Cas Number:
- 128819-84-1
- Molecular formula:
- C18 H30 O9, C21 H35 Cl O10, C24 H38 O12 and C27 H43 Cl O13 (mainly)
- IUPAC Name:
- Reaction products of trimethylolpropane triglycidyl ether and acrylic acid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light and humidity
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TOXI COOP ZRT., Budapest, Hungary
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation:
group of 1st step: 244 g
group 2nd step: 230 - 231 g
group of 3rd step: 247 - 257 g
- Fasting period before study: animals were fasted over-night before and 3 hours after treatment
- Housing: 3 animals of the same sex per cage in Type II polypropylene/polycarbonate cages, laboratory bedding
- Diet: ssniff® SM R/M-Z+H complete diet for rats and mice (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 27 days (group of 1st step), 28 days (group of 2nd step) and 29 days (group of 3rd step)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/ 12
IN-LIFE DATES:
group of 1st step: From: 09 To: 9 Aug 2016
group 2nd step: From: 10 To: 25 Aug 2016
group of 3rd step: From: 11 To: 26 Aug 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi Annui Oleum Raffinatum (sunflower oil)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The applied vehicle is one of the standard vehicles used in acute toxicity studies.
- Lot/batch no. (if required): 8001528001
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose was selected on basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure (according to OECD 423) with the use of 5000 mg/kg bw as the starting dose in one female rat (group of 1st step). Due to the observed death of this female, dosing was proceeded at 2000 mg/kg bw in three females (group of 2nd step) in accordance with the flow charts provided in Annex 2 of OECD 423. No animal died in the second step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats (group of 3rd step). No animal died in the third step, and hence the test was finished. - Doses:
- 5000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 animal for 5000 mg/kg bw
3 animals for 2000 mg/kg bw per step (6 in total) - Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: at least once during the first 30 minutes after substance application, then 1, 2, 3 and 4 h after gavage (all groups) and thereafter twice per day for 14 days (groups of 2nd + 3rd step)
general observations: at least once during first 30 minutes after substance application, then 1, 2, 3 and 4 h after gavage (all groups) and thereafter daily for 14 days (groups of 2nd + 3rd step)
weighing: on Day 0 (all groups), 7 and on Day 15 (groups of 2nd + 3rd step)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, general state, external appearance, behavior, gross histopathology - Statistics:
- No statistical anylysis were performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - <= 5 000 mg/kg bw
- Based on:
- test mat. (dissolved fraction)
- Mortality:
- After administration of 5000 mg/kg bw, the test female died within 4 h after treatment. No mortality was observed after administration of 2000 mg/kg bw.
- Clinical signs:
- other: 5000 mg/kg bw, group of 1st step: On Day 1 (0.5 - 4 h after treatment) several clinical symptoms were observed: decreased activity (4 / 5 observations), vocalisation (3/5), tremor (1/5), abnormal gait (3/5), bedding digging (1/5), closed eyes (3/5), saliv
- Gross pathology:
- No pathological changes related to the test item were observed.
2000 mg/kg bw, group of 2nd step: In 2/3 animals moderate hydrometra was observed. Hydrometra is a physiological finding and connected to the cycle of the animal. Thus, the effect is not considered as treatment-related.
2000 mg/kg bw, group of 3rd step: In 1/3 animals moderate hydrometra was observed. 1/3 animals showed a colon full of gas, which is regarded as an individual variation. Most likely the observation is a consequence of the anaesthesia.
Any other information on results incl. tables
Table 1: Results of acute oral toxicity study
Dose |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
2000 |
0/3/3 |
1-2 h - day 14 |
--- |
0 |
2000 |
0/0/3 |
--- |
--- |
0 |
5000 |
1/1/1 |
0.5 h - death |
Day 1 |
100 |
LD50 = >2000 - ≤ 5000 mg/kg bw |
||||
*first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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