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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:
Oct - Dec 1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to 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)
GLP compliance:
no
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 methyl sulphate
EC Number:
277-232-6
EC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate
Cas Number:
73019-09-7
Molecular formula:
C20H24N3.CH3O4S
IUPAC Name:
1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium methyl sulphate
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
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: male: 9 weeks; female 14 weeks
- Weight at study initiation: male: 166 - 201g; female: 153 - 179g
- Fasting period before study: 16h befor until 4 hours after application
- Housing: Makroloncage Type III in groups of 5
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): mains water ad libitum

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
100, 310, 400, 500, 630 mg/kg
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: day of application: multiple observations; during 3 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
396 mg/kg bw
Based on:
test mat.
95% CL:
> 350 - < 441
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
143 mg/kg bw
Based on:
act. ingr.
Mortality:
all motality occured with in 24h after application, details see Table 1.
Clinical signs:
clinical signes occured 1 minute after application until 3 days after application:
- 310 to 630 mg/kg bw: worse general condition, nausea and sedation
- additionally male from 400 mg/kg bw and female from 310 mg/kg bw: abdominal/lateral position
Body weight:
No effect
Gross pathology:
Male and female animals from dose 310 to 630 mg/kg bw with coloured stomach and small intestine wall. Additionally: stomach without mucosal fold.
Other findings:
No significant difference between male and female animals.

Any other information on results incl. tables

Table 1: results

dose
[mg/kg bw]

sex

animals

dead after

dead

symptomatical

treated

100

m

0

0

5

 -

310

m

0

5

5

 -

400

m

3

5

5

1h

500

m

4

5

5

1 - 24h

630

m

5

5

5

1h

 

 

 

 

 

 

100

f

0

0

5

 -

310

f

1

5

5

24h

400

f

2

5

5

1h

500

f

5

5

5

1h - 24h

630

f

5

5

5

1h

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute LD50 (oral) to male and female rats was calculated to be 396 mg/kg bw under the conditions of the test. Based on the active ingredient, the LD50 is 143 mg/kg bw. The test substance is classified as Category 3 according to CLP criteria.