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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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)-2-{4-[ethyl(2-hydroxyethyl)amino]phenyl}diazen-1-yl]-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:

other: Tif:RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 157-190 g
- Fasting period before study:
- Housing: 5/cage/sex
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 3, 1982 To: March 29, 1982

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

400

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 and 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

300, 1000, 2500, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily, a.m. and p.m. on working days
Signs and Symptoms: daily
Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

From the body weights, the group means and their standard deviations were calculated.
The LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39.357-65, 1944)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 004 mg/kg bw

Based on:

test mat.

Remarks:

API: 55.6%

95% CL:

>= 966 - <= 7 827

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 152 mg/kg bw

Based on:

test mat.

Remarks:

API: 55.6%

95% CL:

>= 660 - <= 82 457

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 120 mg/kg bw

Based on:

test mat.

Remarks:

API: 55.6%

95% CL:

>= 1 279 - <= 4 373

Mortality:

No deaths occurred at 300 mg/kg bw.
At 1000 mg/kg bw, 1 male and 2 females died within two days.
At 2500 mg/kg bw, 2 males and 2 females died within two days.
At 5000 mg/kg bw, all males and 3 females died on Day 1; one further female died on Day 13.

Clinical signs:

Only signs of unspecific toxicity were observed at all dose levels, such as, sedation, dyspnoea, exaphthalmos, ruffled fur, curved body position

Body weight:

All surviving animals showed regular body weight development

Gross pathology:

No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

calculated for 100% API

Executive summary:

Upon a acute oral administration and a 14 day post-treatment observation period, the following lethal doses (with 95 % confidence limits) were

determined for Basic Blue 41 Cl (purity 55.6%).

LD50 in male rats: 2004 (966-7827) mg/kg bw.

LD50 in female rats: 2152 (660-82457) mg/kg bw.

LD50 in rats of both sexes: 2120(1279-4373) mg/kg bw.

Signs of unspecitic toxicity were seen at all dose levels.

According to the company standard Basic Blue 41 has a slight acute toxicity when administered orally to the albino rat.

Calculated for 100% API, the LD50 lies between 300 and 2000 mg/kg bw, and hence results in classification in Category 4 based on GHS CLP criteria.