Registration Dossier
Registration Dossier
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EC number: 229-858-6 | CAS number: 6789-99-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4,5,6,7-tetrahydro-1H-benzotriazole
- EC Number:
- 229-858-6
- EC Name:
- 4,5,6,7-tetrahydro-1H-benzotriazole
- Cas Number:
- 6789-99-7
- Molecular formula:
- C6H9N3
- IUPAC Name:
- 4,5,6,7-tetrahydro-1H-1,2,3-benzotriazole
- Details on test material:
- coarse off-white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SD derived
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Geigy UK
- Age at study initiation: 5 weeks
- Weight at study initiation: 110g (females), 108g (males)
- Fasting period before study: 18 h
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70+/-5
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg - Doses:
- 500, 1000, 1500, 2000, 2500, 3000 mg/kg
- No. of animals per sex per dose:
- 5
- Statistics:
- From the mortality data recorded the LD50 value and its 95% confidence limits were calculated by the method of Litchfield, J.T and Wilcoxon, F. W., 1949, 3. Pharmac. Exp. Ther., 96, 99.
Results and discussion
- Preliminary study:
- In order to determine approximate dose levels for the main study, a range-finding study was carried out using groups of two rats (1 of each sex). The results obtained suggested that the LD50 would be approximately 2000mg/kg.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 100 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 787 - < 2 468
- Mortality:
- yes, see table below
- Clinical signs:
- other: Lethargy was observed starting at the lowest dose levels. In addition, lacrimation (at 1500 and 2000 mg/kg) and piloerection (at 2000 mg/kg) was observed in some animals.
- Gross pathology:
- No Abnormalities detected
Any other information on results incl. tables
MORTALITIES
| mortality | ||||
| Dose (mg/kg bw) | males | females | combined deaths | % |
| 500 | 0/5 | 0/5 | 0/10 | 0 |
| 1000 | 0/5 | 0/5 | 0/10 | 0 |
| 1500 | 0/5 | 1/5 | 1/10 | 10 |
| 2000 | 1/5 | 3/5 | 4/10 | 40 |
| 2500 | 4/5 | 5/5 | 9/10 | 90 |
| 3000 | 4/5 | 4/5 | 8/10 | 80 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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