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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

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:
Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
EC Number:
281-650-4
EC Name:
Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
Cas Number:
84000-94-2
Molecular formula:
C36H42Cl4N12Zn
IUPAC Name:
bis(3-[(E)-2-{4-[benzyl(methyl)amino]phenyl}diazen-1-yl]-1,4-dimethyl-1H-1,2,4-triazol-4-ium); tetrachlorozincdiuide
Constituent 2
Chemical structure
Reference substance name:
Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
EC Number:
281-692-3
EC Name:
Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)
Cas Number:
84012-52-2
Molecular formula:
C36H42Cl4N12Zn
IUPAC Name:
bis[5-({4-[benzyl(methyl)amino]phenyl}diazenyl)-1,4-dimethyl-4,5-dihydro-1H-1,2,4-triazol-1-ium] tetrachlorozincate(2-)
Test material form:
solid
Details on test material:
Basic Red 46 ZnCl4 Multi-const.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH
- Weight at study initiation:
males (161- 178) g
females (172 - 181) g
- Fasting period before study: the animals are given no feed 16 hours before administration, but water is available ad libitum.
- Housing: 5 rat housing in a stainless steel wire mesh cages, type DK-III
- Diet: kliba-labordiaet. fa. klingentalmuehle ag ch-4303 ka i seraugst, switzerland.ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully air-conditioned room by central air-conditioning system
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light between 6:00 AM to 6:00 PM

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
Form of administration: suspension

Amounts administered:
- Dose (mg/kg) 1210 825 562
- Conc. (w/v) 12.10 8.25 5.62
- Adm. vol. (ml/kg) 10 10 10
Doses:
562, 825, 1210 mg/kg bw
No. of animals per sex per dose:
5 per sex per doses
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14
- Frequency of observations and weighing: recording of signs and symptoms several times on the day of administration, at least once each workday. check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: gross-pathological examination
Statistics:
The slope factor was calculated by probit analysis, cambridge university press, 3rd ed., 1971

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 934 mg/kg bw
Based on:
test mat.
95% CL:
> 785 - < 1 145
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 560.4 mg/kg bw
Based on:
act. ingr.
Mortality:
yes
Clinical signs:
other: dyspnoea, apathy, staggering, urine red, salivation, poor general state
Gross pathology:
snout, paws and mucosa of stomach discolored by the test substance

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 (oral, gavage) of the test substance to male/female rats is 934 mg/kg bw corresponding to 560 mg/kg bw based on active ingredient. The substance is classified as Category 4.
Executive summary:

The substance has been tested for acute toxicity by oral route. The substance was administered by gavage at nominal concentrations of 562, 825 and 1210 mg/kg bw to 5 females and 5 males rats. Signs and symptoms are registered several times on the day of administration and at least once each workday. The check for moribund and dead animals was registered twice each workday and once on holidays. Under the test conditions the substance couse dyspnoea, apathy, staggering, urine red, salivation and poor general state. The autopsy reveals snout, paws and mucosa of stomach discolored by the test substance. The LD50 of the test substance is 934 mg/kg b.w. corresponding to 560.4 mg/kg b.w based on active ingredient.