Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)

Endpoint summary

Description of key information

LD50(oral) = 560.4 mg/kg bw (based on active ingredient)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

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

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

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 562 mg/kg bw

Based on:

test mat.

Remarks on result:

other: nominal

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 934 mg/kg bw

Based on:

test mat.

Remarks on result:

other: nominal

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

560.4 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The acute toxicity of the target substance was evaluated by means of Read Across approach. The complete justification for the Read Across approach is detailed at section 13.

No studies are available on the substance in itself, therefore the whole data set of the most similar substances were considered in order to perform the assessment. The substances considered for the evaluation are different salification of the Target substance.

A complete summary of the available data is attached. The results of the tests are concordant exept one study conducted on an undefined zink salt that can be considered as disregarded.

The study selected as the most representative and conservative was performed on Similar Substance 3 [DyStar Colours Distribution GmbH, 1985], according to a method similar to OECD 401. Under the test condition the substance sowed an LD50 = 934 mg/kg bw based on nominal concentration, corresponding to LD50 = 560.4 mg/kg bw based on active ingredient.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:

 

For Acute toxicity oral route:

Category 1: ATE <= 5 mg/kg bw

Category 2: 5 < ATE <= 50 mg/kg bw

Category 3: 50 < ATE <= 300 mg/kg bw

Category 4: 300 < ATE <= 2000 mg/kg bw

 

Taking into account the information available (LD50 = 560.4 mg/kg bw based on active ingredient) the substance has to be classified as Category 4 (H302) for acute oral toxicity.