Registration Dossier
Registration Dossier
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EC number: 280-055-7 | CAS number: 82864-58-2
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 May 22th to June 6th, 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Source study has reliability 1. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nosan no. 8147, 2000
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Specie: Rattus norvegicus.
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: young adult rats 8 - 10 weeks old.
- Variation in weight: not greater than 20 % of the mean weight.
- Housing: 3 animals per cage.
- Diet: pelleted commercial diet (Biobase Biotec), ad libitum. Feed is analysed by testing laboratory periodically for microbiological contaminants
- Water: filtered water, ad libitum.
- Fasting period before study: animals were fasted approxirnately 14 hours prior to the test substance administration. Animals returned to ad Iibitum feeding apprornmately 3 hours after dosing.
- Acclimatization period: 5 days prior to dosing in a controlled room.
- Selection: animals exhibiting abnormal signs during the acclimatization period were not used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 62 %
- Photoperiod: 12 hours cycle dark/light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- Rationale for the selection of the starting dose: as test substance was suspected not to be toxic, 2000 mgkg bw was the selected dose for starting. The time interval between treatment groups was determined by the onset, duration and severity of toxic signs.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Two groups of 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: body weights were recorded shortly before administration, weekly thereafter and at the end of the study. Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1).
- Necropsy of survivors performed: at the end of 14 days, carbon dioxide was used for euthanasia of the animals. Gross pathology examination was performed for 100 % of the animals. Necropsy findings were registered for the intestinal tract (duodenum, jejunum, ileum, cecum) and the major organs such as liver, kidney, heart, spleen, Iymph nodes, respiratory tract (lungs, trachea, bronchi, diaphragm), thyroid, oesophgus, stomach, pancreas, muscles, bladder, uteus and gonads. After examination, animals were wrapped and disposed as a special residue of the Municipal Health Service.
- Other examinations performed: sign and symptoms were recorded at least once each workday for individual animals. A check for dead or moribund animals were made once at least once each workday and once on Saturdays, Sundays and on public holidays. Clinical observations included possible changes in skin and fur, eyes and mucous membranes, dyspnoea, changes in the behaviour, tremors, convulsions, salivation, diarrhea, prostration, coma and death.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed among the tested animals.
- Clinical signs:
- No treatment related signs were observed after a single administration.
- Body weight:
- Body weight changes were within the range of physiological variability.
- Gross pathology:
- No macroscopic changes were observed in any of the major organs of the examined animals.
Any other information on results incl. tables
Individual and group rnean body weight (bw) of animals treated at 2000 mg/kg bw of the test substance
| Animals | Bw (g) | |||
| Day 1 | Day 7 | Day 14 | Bw changes | |
| 1 | 172.9 | 202.5 | 219.7 | + 46.8 |
| 2 | 185.8 | 206.9 | 221.4 | + 35.6 |
| 3 | 163.6 | 185.6 | 198.6. | + 35.0 |
| 4 | 176.7 | 194.1 | 204.8 | + 28.1 |
| 5 | 184.2 | 212.0 | 223.9 | + 39.7 |
| 6 | 184.9 | 189.5 | 197.9 | + 13.0 |
| Mean | 178.0 | 198.4 | 211.0 | + 33.0 |
Individual clinical observation of animals treated at 2000 mg/kg bw of the test substance
| Animals | Days of observation | ||||||
| 1 | 2 | 3 – 5 | 6 | 7 | 8 | 9 – 14 | |
| 1 | NA | NA | NA | NA | NA | NA | NA |
| 2 | NA | NA | NA | NA | NA | NA | NA |
| 3 | NA | NA | NA | NA | NA | NA | NA |
| 4 | NA | NA | NA | NA | NA | NA | NA |
| 5 | NA | NA | NA | NA | NA | NA | NA |
| 6 | NA | NA | NA | NA | NA | NA | NA |
NA: no alterations
Individual necropsies of animals treated at 2000 mg/kg bw of the test substance
| Macroscopic observations | Females | |||||
| 1 | 2 | 3 | 4 | 5 | 6 | |
| Oesophagus | NA | NA | NA | NA | NA | NA |
| Trachea | NA | NA | NA | NA | NA | NA |
| Thyroid | NA | NA | NA | NA | NA | NA |
| Lungs | NA | NA | NA | NA | NA | NA |
| Bronchi | NA | NA | NA | NA | NA | NA |
| Heart | NA | NA | NA | NA | NA | NA |
| Diaphragm | NA | NA | NA | NA | NA | NA |
| Stomach | NA | NA | NA | NA | NA | NA |
| Intestine | NA | NA | NA | NA | NA | NA |
| Spleen | NA | NA | NA | NA | NA | NA |
| Pancreas | NA | NA | NA | NA | NA | NA |
| Liver | NA | NA | NA | NA | NA | NA |
| Lymph nodes | NA | NA | NA | NA | NA | NA |
| Muscles | NA | NA | NA | NA | NA | NA |
| Kidney | NA | NA | NA | NA | NA | NA |
| Bladder | NA | NA | NA | NA | NA | NA |
| Ovarium | NA | NA | NA | NA | NA | NA |
| Uterus | NA | NA | NA | NA | NA | NA |
NA: no alterations
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
The study was carried out to assess acute toxicity following a single oral administration to rats of the test substance according to the OECD guideline 423. Wistar rats (Rattus norvegicus) were selected and maintained under controlled environmental conditions. Based on individual body weight, dosing of the test substance was calculated in mg/kg body weight (bw). Two groups of three female rats received 2000 mg/kg bw. Animals were observed for 14 days.
At the end of this period, no mortality or signs of evident toxicity were observed. Gross pathology examination was performed on all tested animals. No macroscopic alterations were observed in any of the major organs of the examined animals. Under the test conditions, the LD50 was found to be greater than 2000 mg/kg bw. Therefore, the test substance is not acutely toxic via the oral route.
Conclusion
LD50 > 2000 mg/kg bw
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