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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 231 mg/kg bw
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:
At 1000 and 2000 mg/kg bw sedation
At 1000 mg/kg bw in 3 male rats chromodakryorrhoe
Body weight:
After application of 1000 mg/kg bw decreased growth of the male rats in the first week.
Equal to and exceeding 500 mg/kg bw preliminary decreased body weight of the female rats
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.