5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)

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

Study period:

From March 29 to May 22, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Source study has reliability 1. Details on the read across are attached in section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Acclimation period: 5 days
- Source: Winkelmann, Borchen
- Age at study initiation: 8 weeks (M), 10 weeks (F)
- Average weight at study initiation: 179 g (M), 178 g (F)
- Housing: Makrolon Cages Type III, with antidust pellet Holgranulat (FIRMASSNIFF, Soest/Westfallen)
- Diet: Altromin®1324 Pellets (Altromin GmbH, Lage)
- Water: drinkable water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 ± 10%
- Photoperiod: 12h / 12h (light from 6 to 18)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mg/kg

Doses:

200, 350, 500, 1000 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day
- Frequency of weighing: before administration, after 1 week to the administration, at the end of observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Spearmann & Kärber Method

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 395 mg/kg bw

Based on:

test mat.

95% CL:

ca. 164 - ca. 626

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 275 mg/kg bw

Based on:

test mat.

95% CL:

ca. 188 - ca. 738

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 177.8 mg/kg bw

Based on:

act. ingr.

Effect levels 4

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 124 mg/kg bw

Based on:

act. ingr.

Mortality:

Male:
200 mg/kg (no animal died, 0 % mortality)
350 mg/kg (3 animals died after 1h from administration, 60 % mortality)
500 mg/kg (3 animals died from 2 to 4 h after administration, 60 % mortality)
1000 mg/kg (5 animals died after 1h from administration, 100 % mortality)

Female:
200 mg/kg (1 animal died after 2h from administration, 20 % mortality)
350 mg/kg (4 animals died from 1 to 4 h after administration, 80 % mortality)
500 mg/kg (5 animals died after 2h from administration, 100 % mortality)
1000 mg/kg (5 animals died after 1h from administration, 100 % mortality)

Clinical signs:

other: Sedation, abdominal position, cramps, gasping

Gross pathology:

Negligible hystological examination

Other findings:

At pathological-anatomical examination of animals dead upon doses of 200 to 1000 mg/kg, the gastric mucosa had passed, the fundus of the stomach and the intestines reddened; in a male and female of dose 350 and in several animals at doses of 500 and 1000 mg/kg, the lung was red.

Any other information on results incl. tables

Males

dose	200	350	500	1000
vol. administered	10	10	10	10
no. died animals	0	3	3	5
no. of animals with symptoms	0	5	5	5
no. used animals	5	5	5	5
beginning of symptoms		30'	15'	15'
end of symptoms		1d	1d	1h
death		1h	from 2h to 4h	1h
	no. of animals/intensity (1 = low, 2 = medium, 3 = high)
general condition		3/1
sedation		5/3	5/3	5/3
abdominal position		4/1	4/1	5/1
cramps		1/1
gasping		4/1		5/1

Females

dose	200	350	500	1000
vol. administered	10	10	10	10
no. died animals	1	4	5	5
no. of animals with symptoms	2	5	5	5
no. used animals	5	5	5	5
beginning of symptoms	30'	30'	15'	15'
end of symptoms	2h	4h	2h	1h
death	2h	from 1h to 4h	2h	1h
	no. of animals/intensity (1 = low, 2 = medium, 3 = high)
sedation	2/1	4/3	5/3	5/3
abdominal position	2/1	4/1	5/1	5/1
gasping	2/2	4/1	5/1	5/1

Applicant's summary and conclusion

Interpretation of results:

other: cat. 3, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 (male) = 395 mg/kg.
LD50 (female) = 275 mg/kg.

Executive summary:

Method

The substance was tested according to the EU method B.1. Five rats per sex per dose have been used at concentrations of 200, 350, 500, 1000 mg/kg. Effects and mortality were recorded.

Results

Clinical signs and mortality were observed from 15 minute to 1 day after the administration. LD50 of the substance for male rats is 395 mg/kg (177.8 mg/kg a.i.), and for female rats is 275 mg/kg (124 mg/kg a.i.).

Clinical signs in terms of sedation, abdominal position, cramps and gasping were noted. Males dosed at dose of 200 mg/kg (90 mg/kg a.i.) were without symptoms.