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

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977-04-21

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

only one hour exposure

Principles of method if other than guideline:

The exposure time was one hour.

GLP compliance:

no

Test type:

traditional 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 material form:

solid

Details on test material:

see below

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 211-240 g males
158-186 g females
- Fasting period before study: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 87
- Atmospheric pressure: 758 mmHg

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 300 litres
- Temperature, humidity, pressure in air chamber: 25 °C, 87%, 758 mmHg
- Air flow into exposure chamber: 49.2 litres/min
- Air flow through MSA Dust Sampler (5.0 micron MSA filter): 7.8 litres/min
- Dust "dropped" into exposure chamber (through 60 mesh sieve, opening 0.25 mm): 600 g
- Concentrations in exposure chamber: 1.2829 mg/L (5 min), 1.0125 mg/L (30 min), 0.8269 mg/L (50 min)

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

1 h

Concentrations:

1.0408 mg/L (mean concentration)

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: not specified
- Other examinations performed: clinical signs, body weight
- other: Test item was dried over night at 60 °C

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC0

Effect level:

1.041 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.041 mg/L air

Based on:

test mat.

Exp. duration:

1 h

Mortality:

No mortality observed

Clinical signs:

other: no signs of toxicity observed

Body weight:

The body weight gain was subnormal in both males and females.
males: 40.7 g (30-57 g)
females: 18.6 g (10-24 g)

Gross pathology:

not specified

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the LC0 of the test item is greater than 1.0408 mg/L.

Executive summary:

In an acute inhalation toxicity study, groups of young adult Osborne-Mendel rats (5/sex) were exposed by inhalation route to the test item in air for 1 hour to the whole body at a mean concentration of 1.0408 mg/L. Animals then were observed for 14 days. There were no treatment related clinical signs nor mortality, though the body weight gain was sub normal. Based on these results, the LC0 of the test item is greater than 1.0408 mg/L.

The test item is considered to be of low toxicity and does not warrant for classification.