Registration Dossier
Registration Dossier
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EC number: 235-834-6 | CAS number: 13001-38-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From July 20 to August 21, 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Complete read-across justification is attached in section 13. Source study has reliability 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- no overnight fasting prior dosing based on Swiss Tierschutzkommission.
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- yes
- Remarks:
- no overnight fasting prior dosing based on Swiss Tierschutzkommission.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar Substance 03
- IUPAC Name:
- Similar Substance 03
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hanlbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & animal breeding division, Wölferstrasse 4, CH 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: males 239.7 - 249.7 g; females 175.5 - 188.3 g
- Housing: groups of 3 in Makrolon type-4 cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Fasting period before study: 1 h
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 23.5 °C
- Humidity: 39 - 61 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 h artificial fluorescent light, 12 h dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle in gavage: 10 ml
- Lot/batch no. (if required): 405374/1 30600
MAXIMUM DOSE VOLUME APPLIED: 10 ml - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observation for mortality: once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration on test day 1 and twice daily during days 2 - 15.
- Frequency of observation body weights: on test day 1 (pre-administration), 8 and 15
- Frequency of observation for clinical signs: each animal was examined for changes in appearance and behaviour once daily during acclimatisation period, 1, 2, 3 and 5 h after test item administration and once daily during days 2 - 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths.
- Clinical signs:
- other: No clinical signs.
- Gross pathology:
- No macroscopic findings at necropsy.
Any other information on results incl. tables
Body weight in g
| dose level (mg/kg) | animal no. | group mean body weights | ||
| day of treatment | day 8 | day 15 | ||
| 2000 (F) | 1 | 175.5 | 184.7 | 191.2 |
| 2 | 188.3 | 196.5 | 203.2 | |
| 3 | 178.2 | 185.8 | 197.7 | |
| 2000 (M) | 4 | 239.7 | 262.9 | 286.0 |
| 5 | 240.4 | 148.4 | 273.5 | |
| 6 | 249.7 | 166.3 | 287.4 | |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 (rat) > 2000 mg/kg bw.
- Executive summary:
Method
Acute toxicity by oral route based on acute toxic class method, according to OECD 423. The study was carried out as limit test. A dose of 2000 mg/kg bw was adminstered by gavage to 3 animal/sex using PEG 300 as vehicle. Animals were observed up to 14 days after dosing.
Results
No deaths occurred, thus an LD50 > 2000 mg/kg was established. Body weight gains during the study period were normal.
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