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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
Study period:
March 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
EC Number:
264-497-8
EC Name:
1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
Cas Number:
63817-45-8
Molecular formula:
C27H31N2O.Cl
IUPAC Name:
2-ethyl-3-[1-(2-hydroxyethyl)-2,2,4-trimethyl-1,2,3,4-tetrahydroquinolin-6-yl]-2-azatricyclo[6.3.1.0^{4,12}]dodeca-1(11),2,4(12),5,7,9-hexaen-2-ium chloride
Test material form:
solid
Details on test material:
Basic Blue 147 Cl

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 wks
- Weight at study initiation: 163 g (mean)
- Fasting period before study: 16 h
- Housing: Makrolon Type III cages (group of 5 animals)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.5
- Humidity (%): 55 - 65
- Light/darkness (h): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Lutrol
Details on oral exposure:
20 mL/kg bw application volume
Doses:
100, 600, 1000, 3100, 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: h 0 and d 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Probit analysis

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
805 mg/kg bw
Based on:
act. ingr.
95% CL:
> 490 - < 1 232
Mortality:
100: 0/10; 600: 2/10; 1000: 5/10; 3100: 8/10; 5000 mg/kg bw: 10/10 dead
Death occurred between 4 h and 14 d after application.
Clinical signs:
100: no symptoms; 600 - 5000: bad general condition; 1000 mg/kg bw: scrubby fur
Symptoms occurred between 5 min to 1 h after application.
Body weight:
600 mg/kg bw: weight loss
Gross pathology:
No findings

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 (oral, gavage) in male rats was determined to be 805 mg/kg bw (act. ingr.). The substance is classified as Category 4 according to CLP criteria.