Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The test was conducted on a similar substance, the complete justification for the Read Across approach is reported at section 13. The original Reliability of the test is 2

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)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Basic Red 046 ZnCl4 bis - Similar Substance 04

IUPAC Name:

Basic Red 046 ZnCl4 bis - Similar Substance 04

Test material form:

not specified

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:

other: PHYSIOLOGICAL MEDIUM

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 b.w

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 562 mg/kg bw

Based on:

test mat.

Remarks on result:

other: nominal

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 934 mg/kg bw

Based on:

test mat.

Remarks on result:

other: nominal

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 560.4 mg/kg bw

Based on:

act. ingr.

Mortality:

yes

Clinical signs:

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:

other: Category 4 According to the CLP Regulation EC n. 1272/2008

Conclusions:

The LD50 of the test substance is 934 mg/kg b.w. corresponding to 560.4 based on active ingredient

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.