2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1970-04-07

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:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

EC Number:

248-053-0

EC Name:

2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium chloride

Cas Number:

26850-47-5

Molecular formula:

C19H23ClN4O2S

IUPAC Name:

2-[(E)-{4-[Ethyl(2-hydroxyethyl)amino]phenyl}diazenyl]-6-methoxy-3-methyl-1,3-benzothiazol-3-ium chloride

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 140.5 - 152.3 g (males); 120.7 - 129.8 g (female)
- Fasting period before study: 18 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
Prepared at 250 mg/mL as a suspension in water (sonified for 2 minutes) and diluted serially with vehicle to 102.4 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

2048, 2560, 3200, 4000 and 5000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Statistics:

The LD50 value was determined by the Litchfield-Wilcoxon method.

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

4 300 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 789 - <= 4 881

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

3 700 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 984 - <= 4 588

Mortality:

see Table 1 and 2 in box "Any other information on results incl. tables"

Clinical signs:

Male:
At 2048-5000 mg/kg bw: Reduced activity
At 2560-5000 mg/kg bw: Ptosis, ataxia, diarrhea
At 3200-5000 mg/kg bw: Lethargy, low body position, hypothermia

Female:
At 2048-5000 mg/kg bw: Reduced activity, diarrhea
At 3200-5000 mg/kg bw: Ataxia
At 4000-5000 mg/kg bw: Ptosis, lethargy, low body position, hypothermia

Body weight:

Male:
At 2048-2560 mg/kg bw: Parallel to control

Female:
At 2048 mg/kg bw: Parallel to control
At 2560 mg/kg bw: Slight decrease at end of second week period

Gross pathology:

No findings

Any other information on results incl. tables

Table 1: Mortality Males

Dosage mg/kg bw	Cumulative Mortalities
	Observation day
	1	2	8-14
0	0/6	0/6	0/6
2048	0/6	0/6	0/6
2560	0/6	0/6	0/6
3200	0/6	1/6	2/6
4000	2/6	4/6	4/6
5000	3/6	5/6	5/6

Table 2: Mortality Females

Dosage mg/kg bw	Cumulative Mortalities
	Observation day
	1	2-14
0	0/6	0/6
2048	0/6	0/6
2560	0/6	0/6
3200	0/6	0/6
4000	0/6	2/6
5000	1/6	5/6

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In conclusions, in an acute oral toxicity study the LD50 value was 3700 mg/kg bw for male rats, and 4300 mg/kg bw for female rats.

Executive summary:

In an acute oral toxicity study, groups of fasted Sprague-Dawley rats (6/sex) were given a single oral dose of the test item (92% purity) suspended in water at doses of 0, 2048, 2560, 3200, 4000 and 5000 mg/kg bw and were observed afterwards for 14 days. Reduced activity was seen in all dose groups and both sexes, whereas symptoms like ptosis, diarrhea, ataxia, lethargy and hypothermia were only observed in higher dose groups of both sexes. Based on the mortality, the LD50 value was determined with 3700 mg/kg bw for male rats, and 4300 mg/kg bw for female rats.

 

This information is used in a read-across approach in the assessment of the target substance.

For justification of read-across please refer to the attached read-across report (see IUCLID section 13).