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Diss Factsheets

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:
1971
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

Constituent 1
Chemical structure
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

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