Tosylchloramide sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 1985 - 14 February 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was performed according to standard guideline and under GLP. Other test subtance was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: U.S. Environmental Protection Agency (EPA Publication 54019-82-025)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Tosylchloramide sodium

EC Number:

204-854-7

EC Name:

Tosylchloramide sodium

Cas Number:

127-65-1

Molecular formula:

(C7H4SO2NCl)Na

IUPAC Name:

sodium chloro(4-methylbenzenesulfonyl)azanide

Details on test material:

Ketjensept TC 500 gram (purity not described). The effect concentration is reported as active ingredient.

Label: KETJENSEPT TC 500 gram (Chloramine-T trihydrate, CAS 7080-50-4)
Received From: R.W. Greeff & Co., Inc. 901 Dove Street, Suite 228 Newport Beach, California 92660
Date Received: December 19, 1984
Quantity Received: 1 kilogram
Physical Description: Fine white powder
Storage: Room temperature
Density: Not applicable
Purity and Composition: Not provided by sponsor
Stability: Not provided by sponsor
Concentration Administered: 8.00% w/v concentration in deionized water

Test animals

Species:

rat

Strain:

other: Hsd: (Sd) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Houston Texas, USA
- Age at study initiation: young adult
- Weight at study initiation: males : 288 – 310 gram; female: 216 – 259 gram
- Fasting period before study: at least sixteen hours prior to treatment
- Housing: Cage Type: suspended wire bottom stainless steel. Housing: 1 - 3 per cage. Transfer to Clean Cages: Weekly. Litter Pan Lining: Paper and aspen bedding. Litter Pan Lining Change: Three times weekly.
- Diet (e.g. ad libitum): ad libitum, Purina Formulab Chow #5008
- Water (e.g. ad libitum): ad libitum, automatic
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: 31 January 1985 - 14 February 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 8.00% w/v
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

8% w/v, this corresponds to and LD50 > 381.6 mg/kg for Chloramine-T.

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: Observations for mortality and pharmacologic and/or toxicologic effects were made at least three times on the day of treatment and at least once daily thereafter for fourteen days (day of treatment considered Day 0). Individual body weights were recorded just prior to treatment and on Days 8 and 14.
- Necropsy of survivors performed: yes; A gross necropsy examination was conducted on each animal at termination of the study.
- Other examinations performed: none

Statistics:

no data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 381.6 mg/kg bw

Remarks on result:

other: The acute oral LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Chloramine-T.

Mortality:

No mortality.

Clinical signs:

other: Prominent in-life observations included activity decrease, constricted pupils, piloerection, dilated pupils, and sensitivity to touch.

Gross pathology:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. category 4

Remarks:

according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)

Conclusions:

The acute oral LD50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Tosylchloramide sodium.

Executive summary:

An acute oral toxicity study was conducted on male and female albino rats using test material KETJENSEPT TC 500 gram (hereafter referred to as KETJENSEPT TC). This study was designed and performed in STILLMEADOW, Inc.'s AAALAC accredited laboratory under Pesticide Assessment Guidelines promulgated by the U.S. Environmental Protection Agency (EPA Publication 54019-82-025) and was in compliance with Good Laboratory Practice Standards (Fed. Reg. 48, 53946, 1983). The test material was administered as an 8.00% w/v concentration in deionized water. Five males and five females were dosed at a level of 5010 mg/kg (4.77 ml/kg). No animals died during the study. The acute oral LD-50 for actual KETJENSEPT TC as indicated by the data is greater than 5010 mg/kg (4.77 ml/kg) when administered as a 8.00% w/v concentration in deionized water to albino rats. This corresponds to and LD50 > 381.6 mg/kg for Tosylchloramide sodium.

The substance is classified as Acute oral toxic Cat 4 (H302) according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).