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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Nov -13 Dec 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
EC Number:
281-589-3
EC Name:
5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
Cas Number:
83969-12-4
Molecular formula:
C17H27N6S.CH3O4S
IUPAC Name:
4-{2-[(2E)-5-[bis(propan-2-yl)amino]-3-methyl-2,3-dihydro-1,3,4-thiadiazol-2-ylidene]hydrazin-1-ylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium methyl sulfate
Test material form:
liquid
Details on test material:
Basic Blue 159 methyl sulfate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 wks (male), 14 wks (female)
- Weight at study initiation: mean 181 g (male), 176 g (female)
- Fasting period before study: 16 h
- Housing: Makrolon Type III cages (group of 5 animals)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60 rh
- Light/darkness (h): 12/12
- Acclimation period: min. 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Application volume: 10 mL/kg bw
Doses:
males: 50, 100, 200, 250, 500, 800 mg/kg bw
females: 50, 100, 200, 250, 310 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: daily
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Probit analysis

Results and discussion

Preliminary study:
Probit analysis
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
216 mg/kg bw
Based on:
test mat.
95% CL:
172 - 272
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
124 mg/kg bw
Based on:
act. ingr.
95% CL:
99 - 156
Mortality:
50 mg/kg bw: no mortality
100 mg/kg bw: 0-20%
200 mg/kg bw: 20%
250 mg/kg bw: 80%
310 (female) & 800 (male) mg/kg bw: 100%
Mortality occurred between 1h - 1d after application
Clinical signs:
50 mg/kg bw: no symptoms
100 - 800 mg/kg bw: bad general condition, sedation, prone or later position, bristled fur
200 -800 mg/kg bw: algospams
310 / 800 mg/kg bw: gasping
All symptoms occurred ca. 30 min after application and disappeared until day 2.
Body weight:
Males: no influence
Females: slight growth inhibition from 200 mg/kg bw
Gross pathology:
100 - 800 mg/kg bw: stomach mucosa elapsed, stomach/gut contents reddened and bloated
250 - 800 mg/kg bw: lungs reddened
All survivors from 50 - 500 mg/kg bw were pathologically w/o finding

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The LD50 (oral, gavage) in male and female rats was determined to be 124 mg/kg bw. The substance is classified as Category 3.
Executive summary:

An acute oral toxicity study was carried out with the test item in male and female rats. Five rats/sex/dose groups received a single gavage of the test item dissolved in distilled water at dose levels of 50, 100, 200, 250, 500, 800 mg/kg bw for males and 50, 100, 200, 250, 310 mg/kg bw for females. The animals were observed for signs of toxicity for 14 days thereafter.

Clinical signs observed in animals after a single administration of 100 to 800 mg/kg bw Basic Blue 159 were poor general condition, piloerection, sedation and prone or lateral position. Occasionally, tonic-clonic convulsions, laboured respiration and stilted gait occurred. A slight delay in body weight development was observed in females at a dose of 200 mg/kg bw in the first week of the study. In the pathological-anatomical examination of the deceased male and female rats at doses of 100 to 800 mg/kg bw, non-specific damage to the gastrointestinal tract and in part reddening of the lungs were observed. A dose of 50 mg/kg was tolerated without any clinical signs.

The following deaths were observed during the post-treatment phase:

Dose [mg/kg bw]

No of deaths

Time of death

Mortality rate [%]

males

50

0

-

0

100

0

-

0

200

1

4 h

20

250

4

4-8 h

80

500

4

1 h

80

800

5

2-4 h

100

females

50

0

-

0

100

1

1 h

20

200

1

1 d

20

250

4

4-8 h

80

310

5

4-8 h

100

The resulting oral LD50 for males and females together was calculated to be 216 mg/kg bw (CI 172 to 272 mg/kg bw) based on test material. This calculated to 124 mg/kg bw for the active ingredient.