Benzothiazole

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Method according to directive 84/449EEC, B.3.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzothiazole

EC Number:

202-396-2

EC Name:

Benzothiazole

Cas Number:

95-16-9

Molecular formula:

C7H5NS

IUPAC Name:

benzothiazole

Details on test material:

- Name of test material (as cited in study report): Benzothiazol
- Analytical purity: 97.4 %
- Lot/batch No.: 105488/1990
- Product No.: 680 982 00

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: male rats: 10 weeks; female rats: 15 weeks
- Weight at study initiation: males rats: 239 g; female rats: 215 g
- Fasting period before study: no data
- Housing: Macrolon Type II
- Diet (e.g. ad libitum): "fixed-formula" diet, Altromin 1324 pellets, Altromin GmbH & Co. KG, Lage, Germany
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: shaved back
- Type of wrap if used: covered by alu and plaster (Fermoflex Klebeband, Beyersdorf AG, Germany)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with warm water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

500, 1000 and 2000 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: Observation: twice a day; Weighing: 1 week after administration and at day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

According to Spearmann - Kärber (Angewandte Statistik, 6. Aufl. (1984) 178)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 231 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

933 mg/kg bw

Mortality:

Male rats:
500 mg/kg: 0 of 5
1000 mg/kg: 1 of 5 3 days after application
2000 mg/kg: 5 of 5 1-2 days after application

Female rats:
500 mg/kg: 0 of 5
1000 mg/kg: 3 of 5 1-2 days after application
2000 mg/kg: 5 of 5 1 day after application

Clinical signs:

other: At 1000 and 2000 mg/kg bw sedation At 1000 mg/kg bw in 3 male rats chromodakryorrhoe

Gross pathology:

In places black coloured gastric mucosa and at 2000 mg/kg bw fully filled bladder in died rats.
All at the end of the test killed animals were anatomically inconspicuous.

Any other information on results incl. tables

Acute dermal toxicity of benzothiazole in rats

Dose (mg/kg bw)	Dead rats / rats used	Time of death	Mortality (%)
Males
500 1000 2000	0 / 5 1 / 5 5 / 5	- 3d 1d – 2d	0 20 100
Females
500 1000 2000	0 / 5 3 / 5 5 / 5	- 1d – 2d 1d	0 60 100

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification:
DSD: Xn, R21 Harmful in contact with skin
GHS: Acute Dermal Category 3, H311

Executive summary:

Bomhard, Bayer AG, 1995

The GLP study was performed according to guideline study 402. The acute dermal toxicity of benzothiazole was investigated in 5 male and 5 female rats. The animals were dosed with 500, 1000 and 2000 mg/kg body weight benzothiazole. Sedation was observed at dose levels equal to and exceeding 1000 mg/kg body weight. Also chromodakryorrhoe was observed at 1000 mg/kg bw in 3 female rats. Mortalities occurred at dose levels equal to and exceeding 1000 mg/kg bw 1 to 3 days after administration. The calculated LD50 in male rats was 1231 mg/kg body weight and in female rats 933 mg/kg bw.