Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-09-17 to 2014-12-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform GLP study, well documented report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): (Benzothiazol-2ylthio) Acetic Acid
- Physical state: light yellow white powder
- Analytical purity: 97.58 %
- Purity test date: 2014-05-05
- Lot/batch No.: 41273
- Expiration date of the lot/batch: 2016-01-23
- Storage condition of test material: Cool and dry (+2°C to + 8°C)

Test animals

Species:
rat
Strain:
other: Wistar rats, strain Hsd Han: WIST conventionally bred
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: moistened with Milli-Q water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
There were no clinical signs of toxicity.
Body weight:
All rats gained weight during experimental period except few rats, where in the 8th day body weights were slightly decreased
Gross pathology:
There were no abnormalities detected at the necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the present study results, the acute dermal lethal dose LD50 of (Benzothiazol-2-ylthio)acetic acid is greater than 2000 mg/kg body weight in male and female Wistar rats
Executive summary:

The acute dermal toxicity of (Benzothiazol-2-ylthio)acetic acid was tested in male and female Wistar rats.

Based on the individual body weight, the test item at the dose of 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding sufficient volume of the Milli-Q water and completely transferred on to a cotton gauze (size: Males: 9 x 6 cm; Females: 8 x 5 cm of 6 ply) and applied directly to the clipped skin of the animal to cover about 10% of body surface of the animal. It was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours. After the 24 hour contact period, the dressing was removed and the applied area was washed with water using clean towel and wiped dry with a cotton hand towel.

All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. There were no clinical signs of toxicity and mortality. All rats gained weight during experimental period except few rats wherein the 8thday body weights were slightly decreased. At the end of observation period, all surviving animals were euthanized and subjected to necropsy. There were no abnormalities detected at the necropsy.

Based on the present study results, the acute dermal LD50 of (Benzothiazol-2-ylthio)acetic acidis greater than 2000 mg/kg body weight in male and female Wistar rats.