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Description of key information

In order to determine the acute oral and acute dermal property of the test item two in vivo studies performed in 1985 are provided. The oral lethal dose (LD50) was determined to be 1580 mg/kg bw. The lethal dose (LD50) after dermal application was determined to be greater than 2000 mg/kg bw. No study is available for acuteinhalation toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-05-22 to 1985-06-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All scientific necessary information for evaluation is available. Only the translation of the study report is available. The study was performed according to OECD guideline 401.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Not mentioned in report
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: 0.5% Methylcellulose 400 cps
Doses:
First trial: 1500, 2000 and 2500 mg/kg bw and
Due to mortalities seen with the first three dose levels, additional three dose levels were tested : 1000, 3000, 500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The test started with three dose levels: 1500, 2000 and 2500 mg/kg bw
Due to mortalities seen with the first three dose levels, additional three dose levels were tested : 1000, 3000, 500 mg/kg bw. Gross pathology was investigated at all animals that died during the observation period as well as at all surviving animals at termination of observation period.
Statistics:
according to method published by J. Litchfield and F. Wicoxon (J. Parmacology, 1949, 95-99)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 580 mg/kg bw
Based on:
test mat.
95% CL:
> 1 405 - < 1 776
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of above mentioned study the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 1580 mg/kg bw.
Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered per oral gavage as a solution in 0.5% methyl cellulose 400 cps in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity" referenced as EU Method B.1 (Acute Toxicity (Oral)).

Ten fasted animals per dose group (five per sex) were given a single oral dose of test material at dose levels of 1500, 2000 and 2500 mg/kg bw. Mortality occurred between 2 hours and 6 days after treatment. Due to mortalities seen in each dose group additional three dose levels ( i.e. 500, 1000, 3000 mg/kg bw) were tested in rat groups of 5 females and 5 males per dose thereafter. At 3000 mg/kg bw dose level 5 females and 5 males died within 2 days after treatment. At 1000 mg/kg bw dose 2 females and one male died within 7 days. At the 500 mg/kg bw dose group no mortality occurred. Clinical signs observed at all treated animals during the first 24 hours after treatment were hypoactivity. Some of the rats that died between day 5 and 7 after application appeared cachectic. Necropsy of the animals that died during the study period revealed hyperemia and/or erosion and/or haemorrhagic ulceration of the mucosa of the stomach. No abnormalities were noted at all surviving animals that were killed at end of study period.

Based on the results of above mentioned study, the median lethal dose (LD50) of the test substance after single oral administration to male and female rats, observed over a period of 14 days is 1580 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 580 mg/kg bw
Quality of whole database:
Scientificly well performed and reported guideline conform study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
Reference:
Composition 0
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 information:
Composition 1
Species:
rat
Strain:
other: Wistar rats, strain Hsd Han: WIST conventionally bred
Sex:
male/female
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Scientificly well performed and reported guideline conform GLP study.

Additional information

In order to evaluate the acute oral toxicity of the test substance (Benzothiazol-2-ylthio) acetic acid, an acute oral toxicity study was performed in rats (5 males and 5 females per group). Single oral doses of 1500, 2000 and 2500 mg/kg bw as solution in 0.5 methyl cellulose were applied by gavage. Due to mortalities seen in all dose groups additional three dose groups of (500, 1000 and 3000 mg/kg bw) were tested. Based on the results of this test, the oral lethal dose (LD50) was determined to be 1580 mg/kg bw.

In order to evaluate the acute dermal toxicity of the test substance, an acute dermal toxicity test was performed in wistar rats (5 per sex). A dose of 2000 mg/kg bw test substance moistened with Milli-Q water was applied on to cotton gauze pads direct to the shaved skin of the rats. This pad was covered semi occlusive and held in contact with adhesive tape wound around the torso for 24 hours. After the period of 24 hours the dressing was removed and the applied area was washed with water and wiped dry. All animals were observed for a period of 14 days. No mortality and no clinical signs of toxicity occurred. Based on the results of this test, the dermal lethal dose (LD50) was determined to be greater than 2000 mg/kg bw.

As the vapour pressure of the test substance is low and exposure by inhalation is not relevant, no study on acute inhalation toxicity in animals was performed.


Justification for selection of acute toxicity – oral endpoint
Guideline conform study in rats.

Justification for selection of acute toxicity – dermal endpoint
Guideline conform study in rats.

Justification for classification or non-classification

For the oral toxicity, the test substance (Benzothiazol-2-ylthio)acetic acid has to be classified Category 4, according to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

For the dermal toxicity, the test substance (Benzothiazol-2-ylthio)acetic acid has to be classified Catergory 4, according to Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, as no mortality was observed.

In accordance with column 2 of REACH Regulation (EC) No 1907/2006 Annex VIII no further testing for inhalation toxicity is required taking the vapor presure into account and when the exposure of humans via inhalation is not likely and not a relevant route of exposure. The vapour pressure of the test substance is very low and inhalation is not exposure relevant. No study on inhalation was performed with (Benzothiazol-2-ylthio) acetic acid.