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Toxicological information

Acute Toxicity: oral

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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:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks
- Weight at study initiation: 175 g
- Fasting period before study: 16 hours before and 4 hours after application
- Housing: 5 per cage (Makrolon cages type III)
- Diet: ad libitum (Altormin R 1324, Altromin GmbH, Lage, Germany)
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5 °C
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no data
Doses:
Male rats: 0.1, 0.18, 0.2, 0.23, 0.25, 0.3 ml/kg bw
Female rats: 0.1, 0.13, 0.15, 0.16, 0.18 ml/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2 times per day (observation) and weighing of survivors 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 was calculated by Probit-analysis (Fink and Hund 1965. Arzneim.-Forsch. 15:624).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
257 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
178 mg/kg bw
Mortality:
Males:
0.18 ml/kg bw: 3/10 animals died 8-24 hours after application
0.2 ml/kg bw: 4/10 animals died 4-24 hours after application
0.23 ml/kg bw: 6/10 animals died 8-24 hours after application
0.25 ml/kg bw: 9/10 animals died 2-8 hours after application
0.3 ml/kg bw: 10/10 animals died 2-24 hours after application

Females:
0.13 ml/kg bw: 3/10 animals died 8-24 hours after application
0.15 ml/kg bw: 6/10 animals died 4 hours - 4 days after application
0.16 ml/kg bw: 8/10 animals died 4 hours - 9 days after application
0.18 ml/kg bw: 10/10 animals died 2 hours - 3 days after application
Clinical signs:
paralysis of the rear extremities, bloody tears, narcosis, prone-/ side position, decreased weight and reduced general condition
Body weight:
decreased weight, no individual data
Gross pathology:
no conspicuous findings

Any other information on results incl. tables

Acute oral toxicity

Dose (ml/kg bw)

Time of death

Dead

Symptoms

Number of rats used

Male rats

0.1

0.18

0.2

0.23

0.25

0.3

 

8-24 h

4-24h

8-24h

2-8h

2-24h

0

3

4

6

9

10

10

10

10

10

10

10

10

10

10

10

10

10

Female rats

0.1

0.13

0.15

0.16

0.18

 

8-24h

4h-4d

4h-9d

2h-3d

0

3

6

8

10

10

10

10

10

10

10

10

10

10

10

Male rats: LD50 = 0.206 ml/kg; density: 1.246 g/l; (= 257 mg/kg bw)

Female rats: LD50 = 0.142 ml/kg; density: 1.246 g/l; (= 177 mg/kg bw)

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification:
DSD: T, R25 Toxic if swallowed
GHS: Acute Oral Category 3, H301
Executive summary:

Loeser, E. (Bayer AG), 1982

The acute oral toxicity of benzothiazole was investigated in male and female SPF rats. 6 male and 5 female groups of 10 animals were dosed with 0.1, 0.18, 0.2, 0.23, 0.25, 0.3 ml/kg bw and 0.1, 0.13, 0.15, 0.16, 0.18 ml/kg bw benzothiazole per gavage and observed for 14 days following exposure for mortality and clinical signs. Mortalities occurred at dose levels equal to and exceeding 0.18 ml/kg bw between 8 and 24 hours after administration in male rats and in female rats at dose levels equal to and exceeding 0.13 ml/kg bw between 8 and 24 hours.

Clinical signs like paralysis of the rear extremities, bloody tears, narcosis, prone-/ side position, decreased weight and reduced general condition were observed.

The calculated LD50 for male rats was 0.206 ml/kg bw (=257 mg/kg bw) and 0.142 ml/kg bw (= 177 mg/kg bw) for female rats.