Registration Dossier
Registration Dossier
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EC number: 680-798-0 | CAS number: 886577-76-0
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 - 19 July 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted Dec 2001
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2-isocyanato-2-methyl-3-(prop-2-enoyloxy)propyl prop-2-enoate
- Cas Number:
- 886577-76-0
- Molecular formula:
- C11H13NO5
- IUPAC Name:
- 2-isocyanato-2-methyl-3-(prop-2-enoyloxy)propyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: The test substance should be stored refrigerated and protected from light- Stability: Possibility of polymerization by heat or light
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River Laboratories Japan, Inc., Japan- Age at study initiation: 8.5 weeks- Weight at study initiation: Group 1 (300 mg/kg bw): 198.7 - 206.6 g; Group 2 (300 mg/kg bw): 205.4 - 214.2 g; Group 3 (2000 mg/kg bw): 208.7 - 219.2 g- Fasting period before study: Animals were fasted from the morning on the day before the administration of the test substance- Housing: 3 animals per group were housed in aluminium cages (W 17.5 cm x D 23 cm x H 18.0 cm) with stainless nets in the front and floor.- Diet: pelleted diet (American PMI feed Inc., USA), ad libitum- Water: drinking water (Chiba City Waterworks Bureau, Japan), ad libitum- Acclimation period: 6 days ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3 - Humidity (%): 50 ± 20 - Air changes (per hr): 12 - Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 24 Jun 2005 To: 15-19 Jul 2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE - Justification for choice of vehicle: since the test substance reacts with an aqueous solvent, it was not possible to use it for the preparation. As a result of an investigation of the solvent, it was found that 20% (w/v) solution could be prepared with corn oil, which was selected as the solvent in this study. - Lot/batch no.: 1L2174 MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw CLASS METHOD - Rationale for the selection of the starting dose: The starting dose of 300 mg/kg bw was used according to the OECD test guideline 423.
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (300 mg/kg bw) and 3 (2000 mg/kg bw)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: animals were observed for general conditions immediately for 30 min and after 1, 3 and 6 h on Day 1 and thereafter daily during the observation period; individual body weights were determined on Day 0 (immediately before administration), 3 and 7 days after administration of the test substance and on Day 14 prior to sacrifice. - Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 300 mg/kg bw: 0/6 females died2000 mg/kg bw: 2/3 females died on Day 0 and Day 1, respectively
- Clinical signs:
- other: 300 mg/kg bw: a major decrease in locomotor activity was noted in 1/6 females after 1 - 6 h after treatment with the test substance, in 2/6 females 3 - 6 h after administration, in 1/6 females 3 h after administration and in 1/6 females 6 h after treatmen
- Gross pathology:
- 300 mg/kg bw: Necropsy revealed no substance-related findings.2000 mg/kg bw: - In the 2 animals that died: red discoloration of the glandular stomach was observed, while in 1 of the 2 animals that died blood-like content was noted in the glandular stomach.- In the surviving female (1/3) splenic hypertrophy, hyperplasia of the mucosa of the forestomach, traces of hemorrhage in the serosa of the forestomach, and adhesion of the forestomach to adjacent organs (spleen, liver, peritoneum and diaphragm) was observed.
Any other information on results incl. tables
Table 1 Clinical signs
| Dose (mg/kg bw) | Finding | 0 h | 1 h | 3 h | 6 h | D 1 | D 2 | D 3 | D 4 - 14 |
| 300 mg/kg bw | Normal | 2/3 | 1/3 | 1/3 | 1/3 | 3/3 | 3/3 | 3/3 | 3/3 |
| Decrease in locomotor activity | 0/3 | 1/3 | 1/3 | 1/3 | 3/3 | 3/3 | 3/3 | 3/3 | |
| Soiled fur Periproctal | 0/3 | 1/3 | 1/3 | 2/3 | 0/3 | 0/3 | 0/3 | 0/3 | |
| Loose stool | 1/3 | 2/3 | 2/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | |
| Bloody stool | 0/3 | 2/3 | 2/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | |
| 300 mg/kg bw | Normal | 3/3 | 2/3 | 0/3 | 0/3 | 1/3 | 3/3 | 3/3 | 3/3 |
| Decrease in locomotor activity | 0/3 | 0/3 | 3/3 | 2/3 | 1/3 | 0/3 | 0/3 | 0/3 | |
| Soiled fur Periproctal | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 0/3 | 0/3 | 0/3 | |
| Loose stool | 0/3 | 1/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | |
| Diarrhea | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | ||
| Bloody stool | 0/3 | 1/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | |
| 2000 mg/kg bw | Normal | 0/3 | 0/3 | 0/3 | 0/2 | 0/1 | 0/1 | 0/1 | 1/1 |
| Prone position | 0/3 | 0/3 | 0/3 | 1/2 | 0/1 | 0/1 | 0/1 | 0/1 | |
| Decrease in locomotor activity | 1/3 | 2/3 | 3/3 | 2/2 | 0/1 | 0/1 | 0/1 | 0/1 | |
| Hypothermia | 0/3 | 0/3 | 0/3 | 2/2 | 0/1 | 0/1 | 0/1 | 0/1 | |
| Piloerection | 0/3 | 0/3 | 0/3 | 2/2 | 0/1 | 0/1 | 0/1 | 0/1 | |
| Soiled fur Periproctal | 0/3 | 3/3 | 2/3 | 1/2 | 1/1 | 1/1 | 1/1 | 0/1 | |
| Soiled fur (Red/Brown) Eyes | 0/3 | 0/3 | 0/3 | 0/2 | 0/1 | 0/1 | 1/1 | 0/1 | |
| Soiled fur (Red/Brown) Nose | 0/3 | 1/3 | 1/3 | 0/2 | 1/1 | 1/1 | 1/1 | 0/1 | |
| Ptosis | 0/3 | 0/3 | 1/3 | 1/2 | 0/1 | 0/1 | 0/1 | 0/1 | |
| Watery diarrhea | 3/3 | 0/3 | 1/3 | 0/2 | 1/1 | 1/1 | 0/1 | 0/1 | |
| Bloody stool | 3/3 | 0/3 | 1/3 | 0/2 | 0/1 | 0/1 | 0/1 | 0/1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Oral 4, H302
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