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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well performed and documented toxicological study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The test item is administered oral to groups of rats in different doses.
The animals are examined for 14 days post gavage and sacrificed.
All animals found dead or sacrificed are pathological analysed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Preventol CI 7-100
- Physical state: solid

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPF Cpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 9 (male) 14 (female)
- Weight at study initiation: 174 (male) 167 (female)
- Fasting period before study: 16 hours
- Housing: Makrolon cages type III
- Diet: Altromin R1324 ad libitum except fasting period
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1.5 °C
- Humidity (%): 60 +-5 %
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml / kg
- Justification for choice of vehicle: DMSO is appropriate solvent for the test item
Doses:
500/630/730/800/1000/1300 mg / kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, first day 1, 2, 4, 8, 24 hours
- Necropsy of survivors performed: yes
Statistics:
Calculation of LD50 and confidence interval for p < 0.05 was performed according to Rosiello, J. Tox. Environ. Health, 3, 1977, 797

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 720 mg/kg bw
Based on:
test mat.
95% CL:
> 700 - < 800
Mortality:
in the lowest dose group all animals survived, with increasing dose, the mortality increases up to 100 % in the highest dose group
Clinical signs:
decrease of general condition, Loss of body weight, ventral and lateral position, sedation, paralysis of rear extremities, bloodily mouth
Body weight:
no data
Gross pathology:
The animals died during the study showed an irritation of the stomach mucosa

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
4(or5)-methyl-1H-benzotriazole is harmful to rats by oral gavage. The LD50 is 720 mg/kg bw