N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to US EPA and EU protocol. Minor deviations from animal housing and care AAALAC standards were reported, but were considered to have had no effect on the oucome of this study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: US EPA-TSCA 40 CFR Part 798 section 798.1100

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC No° L 251/94

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide

EC Number:

407-430-1

EC Name:

N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide

Cas Number:

3741-80-8

Molecular formula:

C18H17N3S4

IUPAC Name:

bis(1,3-benzothiazol-2-ylsulfanyl)(tert-butyl)amine

Details on test material:

- Name of test material (as cited in study report): CP-22595
- Physical state: off white powder
- Analytical purity: 89.0 - 93.3%
- Purity test date: 21 December 1989 and 06 April 1990.
- Lot/batch No.: 4064285
- Stability under test conditions: confirmed by HPLC experiment
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Trabbitry, Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: ca 2.1 kg
- Housing: individually housed in suspended stainless steel cages in an environment-controlled room
- Diet (e.g. ad libitum): Agway Prolab Rabbit Ration, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
- Animal identification: metal ear tags and cage cards

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70°F (= ca. 16-21°C)
- Humidity (%): 40-60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each animal using small animal clippers. Care was taken during clipping to avoid accidental abrasion to the skin.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: 20x12cm
- % coverage: approximately 10% of the animal's total body surface
- Type of wrap if used: 8-ply gauze dressing covered with plastic wrap + tubular stockinette sleeve

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: test substance was moistened at dosing with distilled water at a ratio of 0.1 mL/0.1 g in order to enhance test substance contact with the skin.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL water / 0.1g test substance
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity:

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (or other?): 15 days
- Frequency of observations and weighing: observation: daily; weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Range-finding study: male and female rabbits received a single dermal application of the test substance at the following levels:
500, 1000, 1500 and 2000 mg/kg bw.
Exposure period: 24 hours.
Following dosing, the animals were observed for mortality for eight consecutive days. No deaths occurred.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during this study.

Clinical signs:

other: The most notable clinical signs consisted of transient incidences of diarrhea, soft stools, fecal stains and mild erythema at the dermal test sites.

Gross pathology:

Internal observations at necropsy consisted of mottled lungs in 2/10 animals. This pulmonary change may have resulted from the method of sacrifice (T61 euthanasia solution).

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS criteria not met

Conclusions:

Under the conditions of this test, the acute dermal LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the rabbit.