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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: in accordance with the guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
single oral application by gavage of 1000, 2500, 2750, 3000, 3500, 4000 or 5000/kg bw (male rats) and 500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw to female rats in 0.5 ml lutrol/100g bw to 15 male and 15 female Wistar rats per dose. Observation period: 14 d, gross pathological examination, calculation of LD50 by Probit analysis
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: technical pure

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
1000, 2500, 2750, 3000, 3500, 4000 or 5000 mg/kg bw (male rats)
500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw (female rats)
No. of animals per sex per dose:
15
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 227 mg/kg bw

Any other information on results incl. tables

Mortality (male rats)
up to 2500 mg/kg bw no rat died
from 2750 mg/kg bw onward dose-related increase in mortality (2750 mg/kg bw: 3/15; 5000 mg/kg bw: 15/15)
Signs of intoxication
from 2500 mg/kg bw onwards:
poor condition until the 10th day post application and for at least 3 days accompanied by sedation and difficulties in breathing and at higher doses by quasi-narcotic effects.
LD50 (male rats): 3227 (3060-3430) mg/kg bw
Mortality (female rats)
up to 2500 mg/kg bw no rat died
from 3000 mg/kg bw onward dose-related increase in mortality (3000 mg/kg bw: 1/15; 5000 mg/kg bw: 14/15)
Signs of intoxication
from 1000 mg/kg bw onwards:
poor condition until the 10th day post application and for at least 3 days accompanied by sedation and difficulties in breathing and at higher doses by quasi-narcotic effects.
LD50 (female rats): 3860 (3542-4198) mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information
Executive summary:

method: single oral application by gavage of 1000, 2500, 2750, 3000, 3500, 4000 or 5000/kg bw (male rats) and 500, 1000, 2500, 3000, 4000 or 5000 mg/kg bw to female rats in 0.5 ml lutrol/100g bw to 15 male and 15 female Wistar rats per dose. Observation period: 14 d, gross pathological examination, calculation of LD50 by Probit analysis.

result: LD50 (male rats) = 3227 mg/kg bw; LD50 (female rats) = 3860 mg/kg bw), at necropsy 14 days post application a reduced size of abdominal organs, especially liver size was found. Mucus membrane of the stomach with focus of inflammation, stomach content appeared to be bloody.