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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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
EC Number:
268-750-3
EC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Cas Number:
68134-38-3
Molecular formula:
C20H24ClN3
IUPAC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: Winkelmann, Borchen, Germany- Age: 9 weeks male; 14 weeks female- Weight at study initiation: males: 166-201 g; females: 153-159 g (females)- Housing: 5 animals per macrolon cage type III- Diet (e.g. ad libitum): pellets of Altromin R 1234, ad libitum- Water (e.g. ad libitum): tap water, ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 1.5- Humidity (%): 60 +/- 5- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/mg of 630 mg/kg active substanceRATIONALE FOR SELECTION OF DOSES:The doses chosen in this experiment were based on preliminary data.
Doses:
100, 310, 400, 500 and 630 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 clinical observations: at least twice a day (weekends once a day)- Frequency of weighing: before application, after one week and after 14 days.- Necropsy of survivors performed: yes, all animals
Statistics:
Program Probit-Analyse, Fink and Hund (Arzneim Forsch 15, 1965, 624)

Results and discussion

Preliminary study:
N.A.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 300 - <= 400 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 300 - <= 400 mg/kg bw
Based on:
test mat.
Mortality:
All animals in the 630 mg/kg bw dose groups died after treatment. All the females in the 500 mg/kg bw dose group died within 24 hours.Three male and four males died in the 400 and 500 mg/kg dose group. One female and two females died in the 310 and 400 mg/kg dose group.
Clinical signs:
Treated animals for doses from 310 to 630 mg / kg showed reduction of the general condition and sedation.In addition, males from 400 mg / kg, in the case of female animals from 310 mg / kg onwards, occurred in the abdomen.Animals from the low dose showed no signs of toxicity.
Body weight:
No effects on the body weight were noted.
Gross pathology:
All of the experimental animals under test 100 to 500 mg/kg were without any macroscopic abnormal findings.In the deceased male and female animals doses 310 to 630 mg/kg were found stomach and duodenal arrested and looked out oedematoes.
Other findings:
N.A.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In conclusion, in an acute oral toxicity study, the LD50 was determined to be 300-400 mg/kg bw for male and for female Wistar rats.
Executive summary:

In an acute oral toxicity study (OECD 401), groups of young adult Wistar rats (5/sex) were given a single oral dose of the test item in water.

The oral LD50 (males) was determined to be between 300-400 mg/kg bw.